WOODLANDS MULTISPECIALITY

HOSPITAL LIMITED
8/5, Alipore Road, Kolkata – 700 027
Phone: 033-24567075-89
Email: [email protected]
Website: www.woodlandshospital.in

QUALITY MANUAL
(Department of Pathology)
As per ISO 15189: 2022 standards Requirements

Document Number : WMHL/PATH/QM/01

Copy Number : Master
Copy Holder : Quality Manager
Issue Number : 02
Issue Date : 10.08.2023
 Woodlands Multispeciality Hospital Limited
(Department of Pathology)
Doc No. QUALITY MANUAL Section No.: QMS 00
WMHL/PATH/QM/01 ISO 15189:2022

QUALITY MANUAL RELEASE AUTHORIZATION

This Quality Manual is released under the authority of the Head of the Department &
Quality Manager of Woodlands Multispeciality Hospital Limited (Department of
Pathology), The Quality Manager is the designated authority to issue this Quality Manual
in the Laboratory Quality Management System. This manual is the sole property of
Woodlands Multispeciality Hospital Limited (Department of Pathology).

SIGNATURE OF HEAD OF THE DEPARTMENT

DR.-MAINAK CHAKRABORTY
MBBS, MD (PATHOLOGY)
Dated: 10.08.2023

Prepared & Issued By: QM Issue No. 02 Issue Date: 10.08.2023 Approved By:
HOD
Rev. No.: 00 Rev. Date: NIL Page 1 of 1

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AMMENDMENT SHEET
Sl. No. Page Section/ Date of Amendment Made Reasons of Signature of
No. Clause Amendment Amendment Person
No. Authorizing
Amendment
01 All All 10.08.2023 Issue no 01 dated Transition from
19.08.2023 is withdrawn ISO 15189:2012
and issue no 02 dated to ISO
10.03.2023 is re-issued in 15189:2022
system

Prepared & Issued By: QM Issue No. 02 Issue Date: 10.08.2023

Approved By:
HOD
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TABLE OF CONTENTS
CROSS
REFERENCE WITH TOTAL NO. REVISION
SECTION TITLE/CONTENT
ISO 15189 : 2022 OF PAGES STATUS
CLAUSES
COVERPAGE - 1 00

QUALITY MANUAL RELEASE AUTHORIZATION 00

QMS 00 - 1
AMMENDMENT SHEET 00
QMS 01 - 1
TABLE OF CONTENTS 00
QMS02 - 5
FOREWORD 00
QMS 03 - 1
PURPOSE 00
QMS 04 - 1
SCOPE 00
QMS 05 - 1
QUALITY MANUAL REVISION PROCEDURE 00
QMS 06 - 1
DISTRIBUTION OF QUALITY MANUAL 00
QMS 07 - 1
QUALITY POLICY 00
QMS 08 - 1

QMS 09 NORMATIVE REFERENCE & ABBREVIATIONS - 4 00

Quality Manual Sections as per ISO 15189: 2022 Clauses

GENERAL REQUIREMENT
00
QMS 4.1 IMPARTIALITY - 2

4.2.1 00
4.2.2
QMS 4.2 CONFIDENTIALITY 3
4.2.3

00
-
QMS 4.3 REQUIREMENTS REGARDING PATIENTS 2

STRUCTURAL & GOVERNACE REQUIREMENTS

00
QMS 5.1 LEGAL IDENTITY - 1

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CROSS
REFERENCE WITH TOTAL NO. REVISION
SECTION TITLE/CONTENT
ISO 15189: 2022 OF PAGES STATUS
CLAUSES
5.2.1 00
QMS 5.2 LABORATORY DIRECTOR 5.2.2 1
5.2.3
5.3.1 00
QMS 5.3 LABORATORY ACTIVITIES 5.3.2 2
5.3.2
5.4.1 00
QMS 5.4 STRUCTURE AND AUTHORITY 2
5.4.2
00
QMS 5.5 OBJECTIVES AND POLICES - 1

00
QMS 5.6 RISK MANAGEMENT - 1

RESOURCE REQUIREMENTS

6.1 & 6.2, 6.2.1,

6.2.2,6.2.3, 00
QMS 6.0 RESOURCE REQUIREMENTS 6.2.4,6.2.5 5

6.3.1,6.32,6.3.3,
6.34,6.3.5. 00
QMS 6.3 FACILITIES AND ENVIRONMENTAL CONDITIONS 3

6.4.1
6.4.2
6.4.3
QMS 6.4 EQUIPMENT 6.4.5 5 00
6.4.6
6.4.7

6.5.1 00
EQUIPMENT CALIBRATION & METROLOGICAL 6.5.2
QMS 6.5 6.5.3 3
TRACEABILITY

6.6.1 00
6.6.2
6.6.3
QMS 6.6 REAGENTS AND CONSUMABLES 6.6.4 5
6.6.5
6.6.6
6.6.7

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SECTION TITLE/CONTENT
ISO 15189: 2022 OF PAGES STATUS
CLAUSES
6.7.1 00
QMS 6.7 SERVICE AGREEMENTS 6.7.2 2

6.8.1 00
EXTERNALLY PROVIDED PRODUCTS AND 6.8.2
QMS 6.8 3
SERVICES 6.8.3

PROCESS REQUIREMENTS

1 00
QMS 7.0 PROCESS REQUIREMENTS 7.0
00
QMS 7.1 GENERAL - 1

00
7.2.1
7.2.2
7.2.3
QMS 7.2 PRE-EXAMINATION PROCESS 7.2.4 8
7.2.5
7.2.6
7.2.7

7.3.1 00
7.3.2
7.3.3
14
QMS 7.3 EXAMINATION PROCESS 7.3.4
7.3.5
7.3.6
7.3.7
7.4.1 00
QMS 7.4 POST-EXAMINATION PROCESSES 7.4.2 8

00
QMS 7.5 NON-CONFORMING WORKS - 2

7.6.1 00
7.6.2
7.6.3
CONTROL OF DATA AND INFORMATION 7.6.4
QMS 7.6 7.6.5 3
MANAGEMENT

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SECTION TITLE/CONTENT
ISO 15189: 2022 OF PAGES STATUS
CLAUSES
7.7.1 00
QMS 7.7 COMPLAINTS 7.7.2 2
7.2.3
CONTINUITY AND EMERGENCY PREPAREDNESS 00
QMS 7.8 PLANNING - 1

MANAGEMENT REQUIREMENTS

8.1 00
8.1.1
QMS 8.1 GENERAL REQUIREMENTS 8.1.2 2
8.1.3

8.2.1 00
8.2.2
8.2.3
QMS 8.2 MANAGEMENT SYSTEM DOCUMENTATION 1
8.2.4
8.2.5

8.3.1 00
CONTROL OF MANAGEMENT SYSTEM
QMS 8.3 8.3.2 3
DOCUMENTS
8.4.1 00
8.4.2
QMS 8.4 CONTROL OF RECORDS 2
8.4.3

8.5.1 00
ACTIONS TO ADDRESS RISKS AND 8.5.2
QMS 8.5 2
OPPORTUNITIES FOR IMPROVEMENT

8.6.1 00
8.6.2
QMS 8.6 IMPROVEMENT 2

8.7.1 00
8.7.2
QMS 8.7 NON-CONFORMITIES & CORRECTIVE ACTIONS 8.7.3 2

8.8.1 00
8.8.2
QMS 8.8 EVALUATIONS 8.8.3 4

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SECTION TITLE/CONTENT
ISO 15189: 2022 OF PAGES STATUS
CLAUSES
8.9.1 00
QMS 8.9 MANAGEMENT REVIEWS 8.9.2 4
8.9.3
APPENDICES

00
APPENDIX – I PERSONNEL INTERRELATIONSHIP MATRIX - 1

00
APPENDIX-II LIST OF ASSOCIATED DOCUMENTS - 2

00
APPENDIX-III ORGANIZATION CHART - 1

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ISO 15189:2022

FOREWORD

Half a century ago, the idea of privately run Nursing Home was envisaged in Kolkata and several
such were opened, the best known being "Riordans" and the "Elgin"; unfortunately both were
housed in rented buildings not really suitable for this purpose. When they were eventually taken
over by the East India Clinic, it was realized that they were quite inadequate for the
requirements of modern medical care and that a new building was essential.

A considerable period was taken up in negotiating and inspecting various sites. Eventually a fine
open site was secured in Alipore, being a part of the land owned by the Maharaja of Cooch
Behar, on which stood a large house occupied by him known as "Woodlands Palace ", hence the
name of the present Hospital.

On January 8th 1958, Dr. B. C. Roy, the then Chief Minister of West Bengal, himself a distinguised
doctor, laid the foundation stone and building really commenced. From August 17th 1959, the
new nursing home was officially "open" the first three patients being admitted on the 18th, the
first operation being performed, and the first two babies born, on the next day.

Now we have been a common destination for thousands of families in Kolkata and in the Eastern
Region in search of top-of-the-line medical attention for four generations, spanning sixty years.
Today, Woodlands Multispeciality Hospital has added more disciplines, keeping in mind
growing needs of patients. Popularity of Clinics run by the Hospital mirrors the trust of patients
and their families.
Patient care remains core to the fundamental philosophy of the Hospital. We sincerely believe
"Whenever you need care" we are there to serve you.

Laboratory of Woodlands Multispeciality Hospital Limited under the Department of Pathology

has implemented the Quality Management System in conformity with the international
standards of ISO 15189:2022 and NABL 112.

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PURPOSE

This Manual describes the Quality Management System prevailing in Woodlands

Multispeciality Hospital Limited (Department of Pathology) so as to comply with ISO
15189:2022 it includes the following:

 Policies, Practices and Procedures of Woodlands Multispeciality Hospital

Limited, Department of Pathology.
 Provides guideline to follow standard practices in carrying out various
activities pertaining to Laboratory operation.
 Provides information about responsibilities of personnel working in Woodlands
Multispeciality Hospital Limited, Department of Pathology.
 Acts as a reference document for assessment as per ISO 15189:20 22.
 This Quality Manual is prepared as per ISO 15189:2022 standards to satisfy the
Accreditation requirements prescribed by NABL.
 To minimize the effort of Document adequacy audit and to provide guidance
during internal audit, every clause and sub-clause of ISO 15189:2022 is
addressed and maintained as in the original clause and sub clause.
 Quality Manual section numbers are given as per ISO 15189:2022 clauses.
 As prescribed in the ISO 15189:2022 standards, the Quality Manual includes or
makes reference to the supporting procedures. The relevant procedures are
described in the Quality Manual and additional supporting procedures are
addressed in the relevant Quality Manual sections. All Formats used in the
Quality Manual are linked with the supporting procedures, written as
“Associated Procedure”.

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SCOPE:

ISO 15189:2022 Quality management system in the laboratory is developed in the

following discipline of the laboratory:

1. Clinical Biochemistry

2. Clinical Pathology

3. Hematology

4. Histopathology

5. Cytopathology

6. Microbiology & Serology

7. Molecular Biology

The details of tests conducted under these groups are stated in scope of service along
with test methods and detection limits.

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QUALITY MANUAL REVISION PROCEDURE

Quality Manual is revised as per document control procedure described in WMHL/QMSP/16.

Quality Manager or any of the members of the Quality Management System may propose in
the form of document change note with required justification. Laboratory Director will
approve this proposal if justification is valid. Laboratory retains one obsolete copy of the
Quality manual and others Quality Manual copies are being archived.

This Quality Manual is issue no. 02 and issue date is 10.08.2023. Whenever Quality manual is
amended, revision no. of the particular page will be changed. Revised content of the Quality
manual will be identified by Italic fonts.
Distribution of Quality manual is done as per Master list of documents. The document is
prepared for internal purpose. In case any uncontrolled copy outside the organization is
required, it will be issued by the Quality Manager.
Evidence of issue and approval of the Quality Manual is maintained in every page of the
Quality Manual

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DISTRIBUTION OF QUALITY MANUAL:

Distribution of Quality Manual is controlled through document control

procedure; each copy is numbered as indicated below:

Holder Copy No

Quality Manager Master

01

Laboratory director 02

Outside Lab Uncontrolled – Hard Copy

Uncontrolled – Soft Copy

Any consultant and other staff of the quality system can use the copy no. 01 & 02.
Photocopy as required will be done from the master copy.

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QUALITY POLICY

Woodlands Multispeciality Hospital Limited (Department of Pathology) provides total health

care to its patients, with the highest levels of skill, professionalism and ethical practice,
leading to their effective care and treatment at affordable costs. Woodlands Multispeciality
Hospital Limited facilitates medical education and is committed to deliver quality test results
as per established and validated test method. This shall be achieved through developing a
transparent Quality Management System as per the requirements of NABL, competent
personnel familiarized with Quality Management System, teamwork and commitment of the
employees to strive to achieve Customer (Patient/Physician) satisfaction.

OBJECTIVES:

 Implementation and maintenance of Quality Management System as per ISO 15189: 2022.
 All employees of the laboratory will be trained on the Policy, procedure and documentation
developed for quality management system.
 To maintain strict internal quality control according to guide lines lay down by NABL.
 Participation in Inter laboratory and External Quality Assurance programmes to evaluate
test competency.
 To create awareness among the laboratory employees regarding quality management.
 To try and upgrade continuously to keep aware of the latest test methods and implement
developments in laboratory quality management.

SIGNATURE OF HEAD OF THE DEPARTMENT

DR.-MAINAK CHAKRABORTY
MBBS, MD (PATHOLOGY)
Dated: 10.08.2023

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NORMATIVE REFERENCE & ABBREVIATION:
NORMATIVE REFERENCE:
Following documents are used to prepare Quality Manual and implementation of ISO 15189: 2022
Quality Management Systems.
1. ISO 15189: 2022
2. NABL – 112
ABBREVIATIONS
Following Abbreviations are used in Quality Manual
Woodlands Multispeciality Hospital Limited - WMHL
Quality Manager - QM
Quality Manual Section - QMS
Quality Management System Procedure - QMSP
Work Instruction - WI
Standard Operating Procedure - SOP
Internal Quality Audit - IQA
Non Conformity Report - NCR
Consultant Pathologist - CP
Consultant Biochemist - CB
Laboratory Director - LD
In Charge - I/C
Company - Co.
Section - Sec.
Document - Doc.
Deputy - Dy.
Technical - Tech.
Senior - Sr.
Junior - Jr.
Laboratory Technologist - LT
National Physical Laboratory - NPL
National Accreditation Board for Testing & - NABL
Calibration Laboratories
Bureau of Indian Standards - BIS
Indian Standard - IS
Number - No.
Form & Format - FM
Register - RG
FIFO - First In First Out
Process Map - PM
External Quality Assessment Services - EQAS
Laboratory Information System - LIS

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DEFINITION:
CUSTOMER: Patient, Physician/Consultant, Institution who are recommending test may be
called as Customer of The Laboratory.

Terms and definition as per ISO 15189:2022 clauses 3.1 to 3.32:

3.1 Bias/Measurement bias: Estimate of a systematic measurement error.

3.2 Biological reference interval/ reference interval: Specified interval of the distribution of values taken
from a biological reference population.

3.3 Clinical decision limit: Examination result that indicates a higher risk of adverse clinical outcomes,
or is diagnostic for the presence of a specific disease.

3.4 Commutability of a reference material/ commutability: property of a reference material,

demonstrated by the closeness of agreement between the relation among the measurement results for a
stated quantity in this material, obtained according to two given measurement procedures and the
relation obtained among the measurement results for other specified materials.

3.5 Competence: Demonstrated ability to apply knowledge and skills to achieve intended results.

3.6 Complaint: expression of dissatisfaction by any person or organization to a laboratory,

relating to the activities or results of that laboratory, where a response is expected.

3.7 Consultant: person who provides expert advice professionally.

3.8 Examination: set of operations having the objective of determining the numerical value, text value
or characteristics of a property.

3.9 Examination procedure: specifically described set of operations used in the performance of an
examination according to a given method.

3.10. External quality assessment/EQA: evaluation of participant performance against pre-

established criteria by means of interlaboratory comparisons.

3.11. Impartiality: objectivity with regard to the outcome of tasks performed by the medical laboratory.

3.12 Interlaboratory comparison: organization, performance and evaluation of measurements or

examinations on the same or similar materials by two or more independent laboratories in
accordance with pre-determined conditions.
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3.13 Internal quality control/IQC/quality control/QC: internal procedure which monitors the testing
process to verify the system is working correctly and gives confidence that the results are reliable
enough to be released.

3.14 In vitro diagnostic medical device/ IVD medical device: device, whether used alone or in
combination, intended by the manufacturer for the in vitro examination of specimens derived from the
human body solely or principally to provide information for diagnostic, monitoring or compatibility
purposes and including reagents, calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus or other articles.

3.15 Laboratory management: person(s) with responsibility for, and authority over a laboratory.

3.16 Laboratory user: individual or entity requesting services of the medical laboratory.

3.17 Management system: set of interrelated or interacting elements of an organization to establish

policies and objectives, and processes to achieve those objectives.

3.18 Measurement accuracy/ accuracy of measurement/ accuracy: closeness of agreement between

a measured quantity value and a true quantity value of a measurand.

3.19 Measurement uncertainty/MU: non-negative parameter characterizing the dispersion of the

quantity values being attributed to a measurand, based on the information used.

3.20 Medical laboratory/laboratory: entity for the examination of materials derived from the
human body for the purpose of providing information for the diagnosis, monitoring, management,
prevention and treatment of disease, or assessment of health.

3.21 Patient: person who is the source of material for an examination.

3.22 Point-of-care testing/POCT: examination performed near or at the site of a patient.

3.23 Post-examination processes: processes following the examination including review of

results, formatting, releasing, reporting and retention of examination results, retention and storage of
clinical material, sample and waste disposal.

3.24 Pre-examination processes: processes that start, in chronological order, from the user’s request
and include the examination request, preparation and identification of the patient collection
of the primary sample(s) transportation to and within the laboratory, ending when the
examination begins.

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3.25 Primary sample/ specimen: discrete portion of a body fluid or tissue or other sample associated
with the human body taken for examination study or analysis of one or more quantities or
characteristics to determine the character of the whole.

3.26 Quality indicator: measure of the degree to which a large number of characteristics of an object
fulfils requirements.

3.27 Referral laboratory: external laboratory to which a sample or data is submitted for examination.

3.28 Sample: one or more parts taken from a primary sample.

3.29 Trueness/ measurement trueness: closeness of agreement between the average of a large
number of replicate measured quantity values and a reference quantity value.

3.30 Turnaround time: elapsed time between two specified points through pre-examination,
examination, and post examination processes.

3.31 Validation: confirmation of plausibility for a specific intended use or application through the
provision of objective evidence that specified requirements have been fulfilled.

3.32 Verification: confirmation of truthfulness, through the provision of objective evidence that
specified requirements have been fulfilled.

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Doc No. NG/QM/01 QUALITY MANUAL Section No.: QMS 4.1
ISO 15189:2022
4.0 GENERAL REQUIREMENTS:
4.1 IMPARTIALITY
a) Our Laboratory which are engaged in medical testing, are open to all medical laboratory activities
conducted impartially. These activities are organized and managed to ensure impartiality. There is no
discrimination based on patient age, sex, social or economic status, or whether the patient represents
any corporate customers. This policy is also upheld when selecting vendors, subcontractors, or referral
labs.

b) The management of our Laboratory is committed to impartiality. An impartiality policy is prepared

and communicated to all, and the management monitors it by supervising their activities.

c) The laboratory adheres to a steadfast commitment to impartiality within its quality management
system, in accordance with the ISO 15189 standard. The laboratory recognizes the critical importance
of ensuring that its activities remain impartial and unbiased, free from any undue influence or
pressures that could compromise the integrity of its testing processes and results.

Independence and Objectivity:

The laboratory maintains a culture of independence and objectivity in all its laboratory activities. It
ensures that decisions related to testing, analysis, reporting, and quality assurance are made Solely.
Clear and transparent communication regarding the laboratory's commitment to impartiality shall be
maintained both internally and externally. This commitment is communicated to all laboratory
personnel, stakeholders, clients, and regulatory bodies, reinforcing the importance of unbiased testing
practices. Considerations.

Conflict of Interest:
The laboratory establishes mechanisms to identify and manage potential conflicts of interest that could
arise among its personnel, management, or stakeholders. Conflicts of interest that could jeopardize
impartiality is disclosed and appropriately addressed to prevent any compromise to the quality of
testing.

Commercial and Financial Pressures:

The laboratory is rigorously upholding the principle of impartiality by safeguarding its decisions
against any commercial or financial pressures. It neither seek nor accept any undue incentives,
rewards, or inducements that could potentially influence the accuracy or integrity of its testing results

Transparency and Communication:

Clear and transparent communication regarding the laboratory's commitment to impartiality is
maintained both internally and externally. This commitment is communicated to all laboratory
personnel, stakeholders, clients, and regulatory bodies, reinforcing the importance of unbiased testing
practices

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Doc No. NG/QM/01 QUALITY MANUAL Section No.: QMS 4.1
ISO 15189:2022

Supplier and Client Relationships:

Relationships with suppliers and clients is managed with utmost transparency and fairness. The
laboratory avoids situations where such relationships could compromise its impartiality. Selection of
suppliers, subcontractors, and clients is based solely on merit, quality, and suitability of services

d) Continuous Monitoring and Review:

The laboratory's management ensure regular monitoring and review of activities to identify any
potential risks to impartiality. This includes periodic assessments of the laboratory's policies,
procedures, and practices to mitigate any factors that could compromise
impartiality. Relationships that could potentially compromise the laboratory's impartiality,
including ownership, management, shared resources, and financial connections, are
recognized. However, the presence of such relationships does not automatically pose a
threat to the laboratory's impartiality. The laboratory evaluates each case individually and
takes necessary steps to uphold impartiality.

e) If any threat to impartiality is detected, the laboratory acts promptly to eliminate or

minimize its impact, safeguarding impartiality. The laboratory demonstrates transparently
how it addresses and mitigates such threats.

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.: QMS 4.2
WMHL/PATH/QM/01
ISO 15189:2022
4.2 Confidentiality
4.2.1 Management of information
The laboratory's Patient Information Management Policy aligns with the ISO 15189 standard, ensuring
a comprehensive approach to handling patient data. Recognizing the critical importance of patient
privacy and confidentiality, the policy outlines the laboratory's commitment to responsibly manage all
patient information obtained or generated during laboratory activities.

Legally Enforceable Agreements:

The laboratory establishes legally enforceable agreements to establish its responsibility for managing
patient information. These agreements ensure that the laboratory adheres to the highest standards of
privacy and security when handling sensitive patient data.
Privacy and Confidentiality:
Patient information management encompasses both privacy and confidentiality. The laboratory
diligently safeguards patient privacy by ensuring that personal data is protected from unauthorized
access, usage, or disclosure. Additionally, confidentiality measures prevent any unauthorized sharing of
patient information that could compromise the integrity of the data.
Transparency with Users and Patients:
The laboratory is committed to transparency in its operations. It informs users and patients in advance
about the information it intends to make public. This proactive approach empowers users and patients
with awareness and control over the dissemination of their data.
Proprietary and Confidential Information:
With the exception of information that users or patients willingly share publicly, or information agreed
upon for specific purposes like complaint resolution, all other data is considered proprietary and
confidential. This designation underscores the laboratory's dedication to protecting sensitive patient
information from unauthorized exposure.
Commitment to Compliance:
The laboratory upholds its Patient Information Management Policy to remain compliant with ISO
15189 requirements and applicable privacy regulations. By adhering to this policy, the laboratory
reinforces its commitment to responsible patient data management and maintains the trust of its users
and patients.
In summary, the Patient Information Management Policy is a cornerstone of the laboratory's
commitment to maintaining the privacy, confidentiality, and integrity of patient information. By
implementing legally enforceable agreements, ensuring transparency, and treating patient data with
the utmost confidentiality, the laboratory ensures that it operates with the highest ethical and
professional standards in patient information management.

4.2.2 Release of information

Disclosure Under Legal Obligations:
When circumstances necessitate the laboratory to release confidential information based on legal
requirements or contractual agreements, the policy ensures that the affected patient is promptly
notified about the disclosure. This notification practice serves to maintain transparency and uphold the
patient's right to be informed about the use of their confidential information.

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Doc No. QUALITY MANUAL Section No.: QMS 4.2
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ISO 15189:2022

Protection of External Source Information:

The policy extends its commitment to maintaining confidentiality by safeguarding information received
from external sources, such as complainants or regulators, concerning the patient. This implies that
details provided by third parties will be treated with the same level of confidentiality as patient
information originating from within the laboratory.
Confidentiality of Source Identity:
In cases where external sources provide information, the policy places great importance on preserving
the anonymity of these sources. The laboratory ensures that the identity of the source remains
confidential and is not disclosed to the patient without explicit consent from the source. This provision
respects the privacy of the source while maintaining transparency with the patient.
Balancing Disclosure and Privacy:
The policy strikes a balance between disclosure requirements and the privacy rights of both patients
and external sources. By adhering to this policy, the laboratory navigates complex scenarios where
confidential information needs to be shared while respecting legal obligations and maintaining ethical
standards.
Ethical and Regulatory Compliance:
This policy not only underscores the laboratory's ethical commitment to responsible information
management but also ensures compliance with ISO 15189 standards. By treating confidential
information with utmost care, the laboratory cultivates trust with patients, sources, and stakeholders.
In essence, the "Confidential Information Disclosure Policy" is an integral aspect of the laboratory's
quality management system. It ensures that confidentiality, legal requirements, and ethical
considerations are harmoniously addressed when handling confidential information from various
sources within the laboratory's scope.
A non-disclosure agreement is signed by all employees and maintained in the Laboratory
4.2.3 Personnel responsibility
All personnel, including committee members, contractors, external bodies' personnel, and individuals
granted access to laboratory information while acting on behalf of the laboratory, are bound by a
stringent commitment to maintain the confidentiality of all information acquired or generated during
laboratory operations.
Scope of Confidentiality:
Personnel are required to treat all information obtained or created during laboratory activities as
strictly confidential. This includes data, reports, records, patient information, research findings, and any
other sensitive information related to the laboratory's operations.

Personnel Accountability:
All personnel, regardless of their role or affiliation with the laboratory, are individually accountable for
upholding the confidentiality of information they encounter. This responsibility extends to committee
members, contractors, external parties, and others acting on behalf of the laboratory
Committee Members and External Parties:
Committee members, contractors, and personnel of external bodies engaged by the laboratory are
equally bound by this policy. They must adhere to the same standards of confidentiality as internal
personnel

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Doc No. QUALITY MANUAL Section No.: QMS 4.2
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Information Access and Usage:
Information accessed or generated during laboratory activities shall be used solely for authorized
purposes within the context of the laboratory's operations. Unauthorized dissemination, sharing, or use
of information is strictly prohibited
Safeguarding Data
Personnel take appropriate measures to safeguard information from unauthorized access, disclosure,
or loss. This includes secure storage, controlled access, and adherence to data protection protocols
Non-Disclosure Agreement (NDA):
Certain personnel, especially external parties or contractors, may be required to sign a Non-Disclosure
Agreement (NDA) to formalize their commitment to maintaining confidentiality.
Implementation and Compliance:
The laboratory's management is responsible for communicating and enforcing this policy across all
personnel categories. Training and awareness programs ensure that all individuals associated with the
laboratory understand their obligation to uphold information confidentiality. Non-compliance with this
policy may result in appropriate corrective actions and disciplinary measures

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.: QMS 4.3
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ISO 15189:2022
4.3 Requirements Regarding Patients: Ensuring Well-being, Safety, and Rights
Laboratory management, in accordance with a commitment to prioritize patients' well- being, safety,
and rights, establishes and rigorously implements the following processes:

a) Patient and User Feedback: The laboratory provides opportunities for patients and
laboratory users to offer valuable input. This feedback aids the laboratory in the selection of
examination methods and the interpretation of examination results. It fosters a patient-centred
approach to healthcare.

b) Transparent Information Provision: Patients and users are furnished with publicly
available information regarding the examination process. This information encompasses details
such as the procedures involved, associated costs where applicable, and the expected timeline for
receiving results. Transparency in information empowers patients to make informed decisions
about their healthcare.

c) Continuous Examination Review: The laboratory conducts periodic reviews of the examinations it
offers. These reviews ensure that the examinations remain clinically appropriate and necessary in
light of evolving medical knowledge and practices. This proactive approach helps maintain the
quality and relevance of services provided.

d) Incident Disclosure and Mitigation: When appropriate, the laboratory promptly discloses
incidents to patients, users, and any other relevant individuals that have either resulted in patient
harm or had the potential to do so. Comprehensive records are maintained regarding the actions
taken to mitigate these harms. This transparent approach promotes trust and accountability in
patient care.

e) Respectful Treatment: Patients, their samples, and any remains entrusted to the laboratory are
treated with the utmost care, sensitivity, and respect. The laboratory recognizes the significance of
maintaining dignity throughout the entire process.

f) Informed Consent: When required, the laboratory diligently obtains informed consent from
patients. This crucial step ensures that patients are fully aware of the procedures, potential risks,
and benefits associated with their examinations. It empowers patients to make informed decisions
about their healthcare.

g) Safeguarding Patient Samples and Records: The laboratory commits to ensuring the ongoing
availability and integrity of retained patient samples and records, even in circumstances involving
the closure, acquisition, or merger of the laboratory. This safeguarding is essential for the
continuity of patient care and the preservation of their medical history.

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h) Accessibility of Relevant Information: Relevant information concerning a patient's
examinations and health records is made readily accessible upon the patient's request or at the
behest of a healthcare provider acting on their behalf. This transparency facilitates collaborative
and informed healthcare decisions.

i) Ensuring Non-Discrimination: The laboratory staunchly upholds the rights of patients to receive
care that is free from discrimination of any kind. Discrimination is incompatible with the principles
of equitable healthcare. These measures collectively reinforce the laboratory's commitment to
safeguarding the well-being, safety, and rights of patients. By treating patients and their
information with care and respect, obtaining informed consent, ensuring data integrity during
transitions, providing accessible information, and upholding the principle of non-discrimination,
the laboratory fosters an environment that prioritizes patient welfare and rights.

ASSOCIATED PROCEDURE: NIL

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 Woodlands Multispeciality Hospital Limited
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Doc No. QUALITY MANUAL Section No.: QMS 5.1
WMHL/PATH/QM/01
ISO 15189:2022
5 Structural and governance requirements

5.1 Legal entity

Woodlands Multispeciality Hospital Limited (Department of Pathology) is a hospital of its kind in
Kolkata to meet the requirements of ISO 15189:2012 and carrying out its business or work at its
permanent facilities at, and laboratory barring permanent facilities.

Woodlands Multispeciality Hospital Limited was established in the year 1959 and registered under
companies act. The Laboratory is established under clinical establishments Act 1950 (License No:
L/68(95)/R/0210/13):

SL. NO. Functional Name Location

01 Registered Office 8/5 Alipore Road,

Kolkata – 700027

02 Laboratory Do

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 Woodlands Multispeciality Hospital Limited
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Doc No. QUALITY MANUAL Section No.: QMS 5.2
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ISO 15189:2022
5.2 LABORATORY DIRECTOR
5.2.1 Laboratory director competence
Directing the laboratory is an individual or individuals possessing stipulated qualifications, competence,
delegated authority, responsibility, and adequate resources to meet the requisites of this document. This
practice underscores our dedication to effective leadership, regulatory adherence, and sustaining a
conducive environment for quality outcomes.
The Laboratory Director (LD) is a highly experienced consultants in Laboratory Medicine, who possesses
extensive competence in the field. The LD holds delegated responsibility for overseeing the laboratory's
services. The scope of delegated responsibilities is outlined in the responsibility matrix presented in
Appendix – I. The LD assumes accountability for matters pertaining to professionalism, scientific
insights, consultation, advisement, organizational leadership, administration, and educational initiatives.

5.2.2 Laboratory director responsibilities

The Laboratory Director assumes the responsibility of executing the management system, encompassing
the incorporation of risk management across all facets of laboratory operations. This practice ensures
the systematic identification and mitigation of risks to patient care, while also capitalizing on
opportunities for enhancement. The duties and responsibilities are documented and available in the
Laboratory.

5.2.3 Delegation of duties

The Laboratory Director possesses the authority to assign specific duties or responsibilities, or both, to
personnel who are qualified and competent. Such delegation is formally documented. Nevertheless, the
Laboratory Director retains the ultimate accountability for overseeing the entirety of the laboratory's
operations.

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.: QMS 5.3
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ISO 15189:2022
5.3 LABORATORY ACTIVITIES
5.3.1 General
The Laboratory specifies and documents the scope of its laboratory activities, encompassing those conducted not
only at the primary location but also at additional sites (e.g., point-of-care testing, sample collection) as outlined in
this document. The Laboratory asserts conformity with this document solely for this defined range of laboratory
activities. It's important to note that this range excludes externally sourced laboratory activities on an ongoing basis
Woodlands Multispeciality Hospital Limited specified and documented the range of laboratory activities in
Appendix – IV (Scope of Services Provided by the Laboratory),

5.3.2 Conformance With requirements

The Laboratory operates with a meticulous approach to ensure alignment with the requisites of this document, as
well as the expectations of users, regulatory bodies, and entities granting recognition. This principle is applicable
across the entirety of the comprehensive range of laboratory activities, each of which is meticulously specified and
documented.
Irrespective of the location where services are rendered, the Laboratory upholds this commitment unwaveringly.
Whether activities are conducted within the primary premises or external sites, the overarching objective is to
consistently satisfy the established standards, regulations, and expectations. This holistic approach underlines the
Laboratory's dedication to quality, compliance, and the assurance of a seamless experience for all stakeholders
involved.

5.3.3 Advisory Activities

The Laboratory management is responsible for ensuring the availability of suitable laboratory advice and
interpretation that effectively addresses the requirements of both patients and users.
The laboratory is responsible for setting up structured arrangements to communicate with laboratory users
regarding the following, as and when they become relevant:
a) The laboratory currently establishes a comprehensive system to provide guidance concerning the selection and
utilization of examinations. This includes specifying the necessary sample type, outlining clinical indications,
addressing limitations inherent to examination methods, and determining the optimal frequency for examination
requests
The laboratory presently establishes a comprehensive system to offer guidance concerning the selection and
application of examinations. This encompasses advising on the appropriate sample type, clinical indications,
constraints inherent to examination methods, and the recommended frequency for examination requests. As part of
the policy framework, the laboratory undertakes the responsibility of providing guidance on examination selection
and utilization. This entails advising on the suitable sample type, delineating clinical indications, outlining
limitations associated with examination methods, and suggesting the optimal frequency for requesting
examinations This information is available in booklet form, electronic media, and the laboratory website. Moreover,
it is accessible at the reception area and the phlebotomy room. The system aligns with the laboratory's scope of
services, as outlined in the primary sample collection manual.

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b) The system currently encompasses the provision providing professional judgments that pertain to the
interpretation of examination results. This entails a specialized and knowledgeable evaluation of the outcomes
generated from various examinations. These interpretations are founded on the expertise of laboratory
professionals who possess a deep understanding of the scientific principles, methodologies, and clinical significance
associated with the tests performed. Through this system, the laboratory ensures that examination results are not
only accurately generated but also meaningfully understood. Professional judgments are crafted with meticulous
attention to detail, considering the unique context of each patient and their medical history. The goal is to offer
insights that facilitate informed decision-making by healthcare providers, thus contributing to optimal patient care
and treatment strategies
c) The existing system actively promotes the optimal utilization of laboratory examinations. The laboratory
operates a system dedicated to encouraging and facilitating the efficient use of laboratory examinations. This entails
implementing strategies that empower healthcare providers, patients, and users to make informed decisions about
when and how to utilize various examination services. By fostering effective utilization, the laboratory ensures that
examinations are applied judiciously, leading to improved patient care, resource management, and overall efficiency
in the healthcare process. This system aligns with the laboratory's commitment to providing valuable, impactful,
and relevant services to its stakeholders.

d) The operational system encompasses the provision of guidance concerning both scientific and logistical aspects.
This includes addressing situations where samples do not meet the predefined acceptability criteria.

Within the framework of this system, the medical laboratory assumes the responsibility of offering comprehensive
guidance that spans across scientific and logistical considerations. Particularly, the laboratory is equipped to handle
instances where collected samples fail to meet the established criteria for acceptance. In such cases, the laboratory
employs its expertise to navigate the situation, addressing both the scientific reasons behind the sample's non-
conformance and the logistical implications this may entail.
This system operates as a dynamic support mechanism that ensures samples which fall short of acceptability
criteria are not only appropriately managed but also serve as an opportunity for continuous improvement. By
addressing such scenarios, the laboratory reinforces its commitment to quality, accuracy, and integrity in the
examination processes. The scientific insights provided during these instances contribute to the laboratory's
ongoing refinement of procedures, as well as its endeavor to enhance patient care and uphold the highest standards
of service delivery

ASSOCIATED PROCEDURE: Nil

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Doc No. QUALITY MANUAL Section No.: QMS 5.4
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5.4 Structure and Authority

5.4.1 General
a) The laboratory is currently engaged in defining its organizational and management structure. This entails
establishing a clear framework that outlines how the laboratory is structured and managed to ensure efficient
operations. Additionally, the laboratory is actively identifying its position within any parent organization it might be
associated with, clarifying its role and responsibilities within the broader organizational context.
Furthermore, the laboratory is focused on fostering well-defined relationships between different functional aspects.
This includes emphasizing the connections and interactions between management, technical operations, and
support services.

b) In the present scenario, the medical laboratory is actively engaged in a comprehensive approach aimed at
defining the responsibility, authority, and intricate interrelationships of all individuals involved in managing,
executing, or verifying tasks that impact the outcomes of laboratory activities. To achieve this, the laboratory is
meticulously preparing and articulating detailed job descriptions and specifications for every level of employee.
This meticulous process involves crafting job descriptions that clearly outline the roles, responsibilities, and
expectations associated with each position within the laboratory hierarchy. Each job description is carefully tailored
to reflect the unique tasks, accountabilities, and contributions associated with the respective role. These
descriptions are more than just formal documents; they serve as the blueprint for the responsibilities that each
employee undertakes within the laboratory's ecosystem.
Once job descriptions are meticulously crafted, they are effectively communicated to all personnel within the
laboratory. This ensures that every member of the team is fully aware of their roles, responsibilities, and the
expectations that come with their positions. The approach undertaken by the laboratory in delineating
responsibility, authority, and interrelationships within its workforce is a cornerstone of efficient management and
quality assurance. By providing every employee with a well-defined understanding of their contributions and
expectations, the laboratory cultivates an environment of accountability, transparency, and effective teamwork.
Ultimately, this approach contributes to the laboratory's commitment to delivering accurate, reliable, and high-
quality services in the realm of medical diagnostics.

c) The current system within the medical laboratory is focused on ensuring both the uniform application of
laboratory activities and the credibility of results. This is achieved through the meticulous specification of
procedures that govern various aspects of laboratory operations. These procedures are meticulously documented
and addressed in relevant section of the manual and tailored to suit specific tasks, promoting consistent execution.
Additionally, the system places a strong emphasis on result validity, implementing stringent quality control
measures and validation protocols. This ensures that results are accurate, reliable, and maintain their integrity.
Through ongoing personnel training and adherence to these procedures, the laboratory upholds its commitment to
delivering high-quality and dependable medical diagnostic services.

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Doc No. QUALITY MANUAL Section No.: QMS 5.4
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ISO 15189:2022
5.4.2 Quality Management
In the realm of quality management, the laboratory designates personnel who, regardless of their additional roles,
possess the authority and resources necessary for their duties. These duties encompass:
a) Managing the Management System: They are responsible for implementing, maintaining, and continually
enhancing the laboratory's management system.
b) Identifying Deviations: They identify any deviations from the management system or the established procedures
for laboratory operations.
c) Initiating Corrective Actions: In response to these deviations, they take the initiative to prevent or minimize these
deviations.
d) Reporting to Laboratory Management: They regularly report to laboratory management on the performance of the
management system and pinpoint areas where improvement is needed.
e) Ensuring Effective Laboratory Activities: Their overarching responsibility is to ensure that all laboratory activities
are effective in meeting the established quality standards. These crucial responsibilities can be entrusted to one or
more capable individuals.

ASSOCIATED PROCEDURE: NIL

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 Woodlands Multispeciality Hospital Limited
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Doc No. QUALITY MANUAL Section No.: QMS 5.5
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ISO 15189:2022
5.5 Objectives and policies for Excellence
a) Strategic Vision:
1. Meeting Patient and User Needs: Laboratory management commits to defining and maintaining a
strategic vision that revolves around clear objectives and policies. These policies are designed to meet the
unique needs and expectations of patients and users.
2. Commitment to Professional Practice: At the heart of this vision is an unwavering dedication to
upholding the highest standards of professional practice. The laboratory team is instilled with a profound
sense of responsibility for delivering quality services.
3. Examination Integrity: Ensuring the integrity of examinations is a top priority. The laboratory is
steadfast in its commitment to providing examinations that fully serve their intended purposes, adhering
to the most current version of the ISO 15189:2022 standard.

4. Conformity to Standards: Every aspect of laboratory operations aligns with the ISO 15189:2022
document, ensuring compliance and adherence to the latest quality standards.
Laboratory management recognizes that these objectives and policies serve as the compass guiding its
daily operations and continuous improvement efforts. By upholding these principles, the laboratory
strives for excellence in all facets of its work, thereby reinforcing trust and confidence among its
stakeholders.

b) Measurable Objectives: Objectives are quantifiable, allowing for clear and objective assessment. They
are align seamlessly with established policies. Moreover, the laboratory ensures that these objectives and
policies are diligently implemented at every echelon of the laboratory's organizational structure.

c) Preserving Management System Integrity: Laboratory management places a premium on

safeguarding the integrity of the management system, especially during planned changes and their
implementation.
d) Quality Indicators for Performance: To monitor and enhance performance across crucial pre-
examination, examination, and post-examination processes, the laboratory introduces quality indicators.
These indicators cover a spectrum of key metrics, including but not limited to:
• The ratio of unacceptable samples to the total received.
• The frequency of errors at registration, sample receipt, or both.
• The count of corrected reports.
• The rate of compliance with specified turnaround times.

By meticulously addressing these aspects, the laboratory fortifies its commitment to delivering excellence
in healthcare and diagnostic services.

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.: QMS 5.6
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5.6 RISK MANAGEMENT: (Safeguarding Patient Well-being and Care Enhancement)

In its unwavering dedication to patient well-being and continuous improvement, the laboratory instates
comprehensive risk management processes:

a) Identification of Risks and Opportunities: Laboratory management spearheads the establishment,

implementation, and maintenance of systematic processes. These processes serve the dual purpose of
identifying risks that could potentially harm patients and uncovering opportunities for elevating the
quality of patient care. The actions designed to address both risks and opportunities for improvement
are seamlessly integrated into these processes (refer to 8.5 for details).

b) Ongoing Evaluation for Effectiveness: Under the vigilant oversight of the laboratory director, these
processes undergo regular evaluation. The objective is to gauge their effectiveness continually. If any
inadequacies or shortcomings are unearthed during the evaluation, prompt modifications are made to
ensure that the processes remain robust and reliable.

Through these proactive risk management initiatives, the laboratory cements its commitment to patient
safety and the enhancement of healthcare services

ASSOCIATED PRCEDURE: NIL

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 Woodlands Multispeciality Hospital Limited
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Doc No. QUALITY MANUAL Section No.: QMS 6.0
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6.0 RESOURCE REQUIREMENTS
6.1 General
In the present operations of the medical laboratory system, a foundational prerequisite is the consistent
availability of vital resources. These encompass a range of essential components, each playing a pivotal
role in the laboratory's overall functionality.
Personnel: Trained and qualified personnel, including technicians, scientists, and support staff, form the
backbone of the laboratory. Their expertise ensures accurate testing, efficient operations, and adherence
to established protocols.

Facilities: Adequate physical infrastructure is vital for accommodating laboratory equipment, conducting
various tests, and maintaining a controlled environment that is conducive to accurate and reliable results.

Equipment: State-of-the-art laboratory equipment forms the technological backbone, enabling the precise
execution of tests and analyses. Well-maintained and calibrated instruments contribute to the quality and
reliability of the laboratory's outcomes.
Reagents and Consumables: A ready supply of high-quality reagents and consumables is essential for
performing tests accurately. These materials ensure consistent and standardized results across different
samples and testing processes.

Support Services: Access to support services such as waste disposal, equipment maintenance, and data
management systems enhances the laboratory's overall efficiency and ensures seamless operations.
The continued availability of these crucial resources allows the medical laboratory to not only manage its
activities effectively but also to uphold the standards of accuracy, reliability, and quality that are essential
for maintaining patient safety and delivering valuable healthcare insights.

6.2 Personnel:
6.2.1 General: Ensuring Proficient Human Resources

a) Sufficient Competent Workforce: In the current operation of the medical laboratory system, a
vital requirement mandates the presence of adequate and capable personnel. The laboratory
actively ensures access to a competent and suitable number of individuals who possess the
necessary expertise to proficiently carry out its diverse activities. This ongoing availability of
skilled personnel guarantees the laboratory's ability to consistently deliver accurate test results,
maintain operational efficiency, and uphold the highest standards of quality and patient care.

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b) Ethical and Competent Personnel: In the present functioning of the medical laboratory system, a
pivotal requirement dictates that all personnel, whether internal or external, who possess the
potential to impact laboratory activities, are mandated to operate in a manner that embodies
impartiality and ethics. These individuals are expected to demonstrate competence and adhere to
the highest professional standards. Moreover, their actions are in strict alignment with the
laboratory's established management system. By acting in this manner, these personnel contribute
to the maintenance of integrity, accuracy, and quality in the laboratory's operations, ultimately
ensuring optimal patient care and reliable outcomes

c) Prioritizing User Needs and Compliance: In the ongoing operation of the medical laboratory
system, a crucial requirement is the consistent communication to laboratory personnel regarding
the significance of fulfilling both user needs and requirements, alongside the stipulations outlined
in this document. The laboratory actively emphasizes to its personnel the importance of aligning
their efforts with user expectations and adhering to the directives specified in this document. This
continual communication serves to underscore the laboratory's commitment to quality, accuracy,
and patient satisfaction, ultimately contributing to the delivery of reliable and valuable healthcare
services.

d) Effective Onboarding Program: In the present operation of the medical laboratory system, a
crucial requirement entails the establishment of a comprehensive personnel introduction program.
This program is designed to familiarize new personnel with the organization, their designated
department or area of work, and the terms and conditions of their employment. Additionally, the
program provides insights into staff facilities, imparts knowledge about health and safety protocols,
and acquaints individuals with available occupational health services.
By implementing this program, the laboratory ensures that all personnel are well-informed,
equipped, and oriented to their roles and responsibilities, fostering a safe and efficient working
environment and facilitating a smooth integration process.

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Doc No. QUALITY MANUAL Section No.: QMS 6.0
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ISO 15189:2022
6.2.2. Competence Requirements

a) Defining Competence Requirements: In the present operation of the medical laboratory system, a
crucial
requirement entails the establishment of a comprehensive personnel introduction program. This
program is designed to familiarize new personnel with the organization, their designated department
or area of work, and the terms and conditions of their employment. Additionally, the program provides
insights into staff facilities, imparts knowledge about health and safety protocols, and acquaints
individuals with available occupational health services. By implementing this program, the laboratory
ensures that all personnel are well-informed, equipped, and oriented to their roles and responsibilities,
fostering a safe and efficient working environment and facilitating a smooth integration process.

b) Ensuring Competence: In the ongoing operations of the medical laboratory system, a fundamental
requirement is the assurance of competence for all personnel assigned to specific laboratory activities.
The laboratory actively ensures that each individual possesses the necessary skills and expertise to
proficiently execute the tasks within their responsibilities. By verifying and upholding this competence,
the laboratory guarantees the accuracy, reliability, and quality of its operations, ultimately contributing
to effective patient care and reliable healthcare outcomes.

c) Competence Management Process: In the current operation of the medical laboratory system, a
crucial
requirement dictates the establishment of a process dedicated to managing personnel competence. This
process encompasses various aspects such as defining competency requirements, conducting
assessments, and ensuring ongoing proficiency. Additionally, the laboratory actively specifies the
frequency at which these competence assessments occur. By consistently implementing this process,
the laboratory ensures that its personnel maintain the necessary skills, knowledge, and expertise to
effectively perform their roles. This approach contributes to the reliability and accuracy of laboratory
operations while upholding high standards of patient care.

d) Documented Competence Records: In the present functioning of the medical laboratory system, a
critical requirement stipulates the presence of documented information that showcases the
competence of its personnel. This information serves as a tangible record, substantiating the skills,
qualifications, training, and expertise of each individual involved in laboratory activities. By
maintaining this documented evidence, the laboratory consistently validates the capabilities of its
personnel, ensuring that they possess the necessary proficiency to perform their roles effectively. This
practice contributes to the overall reliability, accuracy, and quality of the laboratory's operations,
ultimately benefiting patient care and healthcare outcomes.

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In the current operations of the medical laboratory system, a range of competence assessment methods
are available, which can be flexibly combined as needed:
— Direct Observation: Personnel's proficiency is evaluated by directly observing their performance of
specific activities.
— Monitoring Results Recording: The accuracy and precision of examination results recording and
reporting are consistently monitored.
— Review of Work Records: The assessment involves reviewing records of work completed to ensure
adherence to standards and protocols.
— Problem-Solving Skills Assessment: The capability to solve issues and challenges related to
laboratory activities is evaluated.
— Examination of Specially Provided Samples: Proficiency is gauged through the examination of
samples specifically provided for assessment purposes. These samples can include previously
examined specimens, inter-laboratory comparison materials, or split samples.

By utilizing these methods, the laboratory ensures the ongoing competence of its personnel, thereby
upholding the quality and reliability of its operations.

6.2.3. Authorization
In the ongoing operation of the medical laboratory system, a key requirement involves the
authorization of personnel to carry out designated laboratory activities, encompassing:
a) Method-related Tasks: Personnel are authorized to engage in activities such as selecting,
developing, modifying, validating, and verifying methods.
b) Results Management: Authorization is granted for tasks like reviewing, releasing, and reporting
examination results.
c) Laboratory Information Systems: Personnel are authorized to operate laboratory information
systems, including tasks such as accessing patient data and information, inputting patient data and
examination results, and making necessary changes to patient data or examination results.

By authorizing personnel for these specific tasks, the laboratory ensures a structured and controlled
Approach to its operations, guaranteeing accurate and reliable results while upholding data integrity
and patient confidentiality.

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6.2.4 Continuing education and professional development
In the current functioning of the medical laboratory system, a continuing education program is consistently
accessible to personnel involved in both managerial and technical processes. All personnel actively engage
in ongoing continuing education and frequent professional development, along with participation in other
relevant professional liaison activities. Furthermore, the system ensures that the appropriateness and
effectiveness of these programs and activities are subject to regular review, reaffirming the commitment to
maintaining personnel's knowledge, skills, and expertise at the forefront of advancements in the field. This
approach guarantees that the laboratory operations remain updated, efficient, and aligned with the highest
professional standards.

6.2.5 Personnel records

In the ongoing operations of the medical laboratory system, procedures are established to address essential
aspects, and corresponding records are retained for:
a) Determining Competence Requirements: Procedures are in place to establish the requirements for
personnel
competence, ensuring alignment with roles and responsibilities.
b) Position Descriptions: Position descriptions are documented, outlining the responsibilities, tasks, and
qualifications associated with each role within the laboratory.
c) Training and Re-Training: Procedures are defined for initial training as well as ongoing re-training,
ensuring
personnel possess the requisite skills and knowledge for their roles.
d) Personnel Authorization: Procedures are enacted for granting authorization to personnel, ensuring
that only
qualified individuals engage in specific tasks.
e) Monitoring Personnel Competence: Procedures are implemented to monitor and assess the ongoing
competence of personnel, guaranteeing they maintain the necessary proficiency to perform their duties.
By establishing these procedures and retaining records, the laboratory maintains a structured and
efficient approach to managing personnel competence, ultimately contributing to accurate, reliable, and
high-quality laboratory operations.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Personnel Management and Training: WMHL/QMSP/01

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6.3 FACILITIES AND ENVIRONMENTAL CONDITIONS:
6.3.1. GENERAL
In the present operations of the medical laboratory system, the facilities and environmental conditions are
thoughtfully tailored to accommodate the unique demands of the laboratory's diverse specialty disciplines.
This individualization of environments is done to ensure that the quality of results and the safety of
patients, visitors, users, and personnel remain uncompromised. This critical aspect extends to various
aspects, encompassing not only the main laboratory premises but also any other sites where examinations
are conducted and Point-of-Care Testing (POCT) is performed.
The laboratory is dedicated to meticulously specifying, continuously monitoring, and diligently recording
the stipulated requirements for facilities and environmental conditions. These requisites are established to
mitigate potential influences that can adversely impact result accuracy. This comprehensive approach
addresses an array of environmental factors such as the presence of adventitious amplified nucleic acid,
microbial contamination, dust, electromagnetic disturbances, radiation, lighting conditions, humidity levels,
electrical supply stability, temperature controls, as well as considerations for sound and vibration.
By steadfastly adhering to these stipulations, the laboratory is not only ensuring the validity of its results
but also safeguarding the integrity of its processes. This commitment underscores the laboratory's
dedication to providing accurate diagnostics and maintaining the well-being of all individuals associated
with its operations.

6.3.2. FACILITY CONTROL

In the present operations of the medical laboratory system, comprehensive facility controls are
systematically implemented, recorded, and monitored, with periodic reviews. These controls encompass a
range of considerations in alignment with the diverse specialty discipline requirements:
a) Access Control: Measures are in place to regulate access to the laboratory facilities, meticulously
considering factors like safety, confidentiality, quality maintenance, and the protection of medical
information and patient samples.

b) Contamination Prevention: Robust controls are enacted to prevent contamination, interference, or

any adverse influences on laboratory activities that may arise from sources such as energy, lighting,
ventilation, noise, as well as water and waste disposal systems.

c) Cross-Contamination Prevention: Where examination procedures pose potential risks, or separation

is critical to maintaining accurate results, stringent measures are taken to prevent cross-contamination
that could arise from the lack of proper separation.

d) Safety Facilities and Devices: The laboratory ensures the availability and functional verification of
safety facilities and devices, where applicable. For instance, the functionality of systems like emergency
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release mechanisms, intercoms, alarm systems for cold rooms and walk-in freezers, as well as
accessibility to emergency showers, eyewash stations, and resuscitation equipment are regularly
validated.

e) Facility Maintenance: A dedicated focus is maintained on the consistent functionality and reliability of
laboratory facilities. The facilities are regularly inspected, serviced, and maintained to ensure they
remain operational and dependable.
By rigorously adhering to these controls, the laboratory guarantees an environment that fosters
accuracy, safety, and quality across all specialty disciplines. This commitment underscores the
laboratory's dedication to reliable diagnostics and upholding the highest standards of healthcare
services.

6.3.3 Storage facilities

In the ongoing operations of the medical laboratory system, the storage facilities are meticulously
managed to adhere to the following requirements:
a) Integrity Assurance: The laboratory provides storage space designed to maintain the ongoing
integrity of samples, equipment, reagents, consumables, documents, and records.

b) Cross-Contamination Prevention: Patient samples and materials used in examination

processes are stored with a careful approach that effectively prevents cross-contamination
and deterioration, thus safeguarding result accuracy and quality.

c) Hazardous Materials and Biological Waste: Storage and disposal facilities designated for
hazardous materials and biological waste adhere to appropriate conditions in line with the
classification of these materials. This alignment ensures compliance with statutory and
regulatory requirements, thereby maintaining safety and adhering to legal obligations.

Through this diligent management of storage facilities, the medical laboratory system sustains an
environment that fosters accurate testing, quality results, and adherence to safety and regulatory
standards.

6.3.4 Personnel facilities

In the present operations of the medical laboratory system, specific requirements are established
for personnel facilities, encompassing:

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Toilet Facilities and Drinking Water: Adequate access to toilet facilities and a continuous
supply of drinking water are ensured, upholding the well-being and comfort of personnel.

Personal Protective Equipment (PPE) Storage: Dedicated facilities are provided for the
proper storage of personal protective equipment and clothing, promoting safety and hygiene.

Space for Personnel Activities: The system includes designated spaces for various personnel
activities, including meetings, quiet study, and a rest area. These spaces contribute to a
conducive work environment and support personnel well-being. By adhering to these
requirements, the medical laboratory system creates a work atmosphere that promotes
personnel comfort, safety, and efficiency, ultimately contributing to optimal operational
performance.

6.3.5 Sample collection facilities:

In the present functioning of the medical laboratory system, the sample collection facilities are
designed to meet specific requirements:

a) Result Validity and Quality Assurance: The facilities are structured to ensure that sample
collection is conducted in a manner that preserves result validity and upholds the quality of
examinations, preventing any compromise.

b) Patient Comfort and Privacy: The facilities prioritize patient comfort, privacy, and individual
needs. Considerations include provisions for disabled access, toilet facilities, and accommodations
for accompanying persons such as guardians or interpreters during the collection process.

c) Separation of Areas: The facilities encompass distinct areas for patient reception and sample
collection, maintaining a clear separation to enhance operational efficiency and patient comfort.

d) First Aid Resources: Adequate provisions of first aid materials are available within the facilities,
catering to the well-being and safety of both patients and personnel.
By adhering to these requirements, the medical laboratory system ensures that sample collection is
conducted in an optimal manner, aligning with patient needs, safety, and quality standards.

ASSOCIATED PROCEDURE: NIL

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6.4. Equipment
6.4.1. General
In the ongoing operations of the medical laboratory system, a series of processes are established to address
the lifecycle of laboratory equipment
Selection and Procurement:
Selection and Procurement: Rigorous processes are in place for the selection and procurement of
equipment, ensuring it aligns with the laboratory's needs and quality standards
Installation and Acceptance Testing:
Equipment installation is carried out systematically, followed by acceptance testing. The latter includes the
application of predefined criteria to ascertain the equipment's suitability for use.
Handling, Transport, and Storage: Comprehensive protocols cover the proper handling, transport, and
storage of equipment to prevent any contamination or deterioration.
Use and Maintenance: The utilization of equipment is regulated through defined procedures, and ongoing
maintenance practices are in place to ensure proper functioning.
Decommissioning: When equipment reaches the end of its useful life, decommissioning processes are
undertaken in accordance with established guidelines. This approach encompasses a wide spectrum of
equipment, including hardware and software of instruments, measuring systems, laboratory information
systems, and any equipment that has an impact on the results of laboratory activities, even including
sample transportation systems. By adhering to these processes, the medical laboratory system guarantees
the reliability, accuracy, and efficiency of its operations while minimizing the risk of contamination or
deterioration.

6.4.2. Equipment Requirements

In the ongoing operations of the medical laboratory system, specific requirements are established
concerning equipment:
a) Access to Required Equipment: The laboratory ensures availability of necessary equipment
essential for the accurate execution of laboratory activities
b) External Use of Equipment: If equipment is utilized outside the laboratory's permanent control or
the manufacturer's specified parameters, the laboratory management takes responsibility for
ensuring compliance with the requirements outlined in this document.
c) Identification and Register: Every equipment item capable of influencing laboratory activities is
distinctly labeled, marked, or otherwise identified, and a meticulous register is maintained to track
their status and usage.

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d) Maintenance and Replacement: The laboratory undertakes the maintenance and replacement of
equipment as necessary to guarantee the quality of examination results, sustaining a high standard of
accuracy and reliability.
By adhering to these requirements, the medical laboratory system ensures proper equipment access,
compliance, identification, and maintenance, resulting in reliable and quality examination outcomes

6.4.3. Equipment acceptance procedure

In the present functioning of the medical laboratory system, a comprehensive equipment acceptance
procedure is followed, encompassing several key elements:
Verification of Conformity: The laboratory meticulously ensures that all equipment, regardless of its
location or use, adheres to the specified acceptability criteria before being placed into service or
returned to service. This includes equipment within the laboratory, equipment on loan, equipment
utilized in point-of-care settings, and even equipment employed in associated or mobile facilities, all of
which are authorized by the laboratory
Measurement Capability: Particularly for equipment used for measurement purposes, an essential
criterion is its ability to achieve the required measurement accuracy, measurement uncertainty, or
both. This capability ensures that the equipment is equipped to provide results that are both reliable
and valid. When relevant, the verification of equipment acceptance testing can be based on the
calibration certificate of the equipment being returned. This approach streamlines the verification
process by leveraging existing calibration data, while still maintaining a robust verification process.
By adhering to this procedure and considering the notes, the medical laboratory system ensures the
consistent quality, accuracy, and reliability of its equipment, ultimately contributing to the precision
and validity of its examination results.

6.4.4 Equipment instructions for use

In the ongoing operations of the medical laboratory system, specific requirements are established
concerning equipment instructions for use:
a) Unintended Adjustments Safeguards: The laboratory implements suitable measures to prevent
unintended adjustments of equipment that could potentially lead to the invalidation of
examination results. This ensures that the equipment remains properly calibrated and
functioning optimally.
b) Trained and Authorized Personnel: Equipment operation is entrusted only to trained,
authorized, and competent personnel. This approach guarantees that those utilizing the
equipment possess the necessary expertise to achieve accurate and reliable results.

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c) Readily Available Instructions: Comprehensive instructions for equipment usage, including
those provided by the manufacturer, are consistently accessible. This ensures that personnel
have immediate access to the guidance needed for correct operation.
d) Manufacturer Specifications: Equipment is operated in accordance with the specifications
outlined by the manufacturer. However, in cases where the laboratory performs validation,
deviations from manufacturer specifications are only permissible if the laboratory has successfully
validated the altered usage.
By adhering to these requirements, the medical laboratory system maintains stringent control over
equipment usage, resulting in reliable, valid, and accurate examination outcomes while minimizing
the risk of erroneous adjustments.

6.4.5 Equipment maintenance and repair

In the present operations of the medical laboratory system, specific requirements pertain to
equipment maintenance and repair:

a) Preventive Maintenance Programs: The laboratory establishes preventive maintenance

programs meticulously aligned with the manufacturer's instructions. Any deviations from the
manufacturer's schedules or instructions are documented for transparency.

b) Maintenance and Safe Working Condition: Equipment is maintained to ensure both safe
operation and optimal functionality. This involves various aspects, including ensuring electrical
safety, functioning emergency stop devices, and the proper handling and disposal of hazardous
materials. These tasks are carried out exclusively by authorized personnel.

c) Defective Equipment Management: Equipment found to be defective or falling outside specified

requirements is promptly removed from service. It is clearly labeled or marked as being out of
service until its proper functioning is verified. The laboratory not only examines the impact of
defects or deviations but also takes action to address non-conforming work when identified

d) Decontamination and Repair Space: When applicable, the laboratory follows decontamination
procedures before servicing, repairing, or decommissioning equipment. Adequate space is
allocated for repairs, along with the provision of suitable personal protective equipment, to ensure
the safety of personnel involved in the repair process. By adhering to these requirements, the
medical laboratory system guarantees the safety, accuracy, and proper functioning of its
equipment, ultimately contributing to the reliability and precision of its examination results.
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6.4.6 Equipment adverse incident reporting
In the ongoing operations of the medical laboratory system, specific requirements are established
concerning equipment adverse incident reporting:
Investigation and Reporting: Any adverse incidents or accidents directly attributed to specific
equipment are meticulously investigated. These incidents are reported to the relevant manufacturer,
supplier, or both, based on the situation. Additionally, if necessary, appropriate authorities are notified
in accordance with regulatory requirements.

Response to Manufacturer's Notices: The laboratory has well-defined procedures for responding to
any recall or other notices issued by equipment manufacturers. These procedures encompass a
comprehensive approach to implementing actions recommended by the manufacturer to address the
identified concerns. By adhering to these requirements, the medical laboratory system ensures swift
responses and appropriate
actions in the face of equipment-related adverse incidents, thereby upholding safety, quality, and
regulatory compliance in its operations

6.4.7 Equipment records

In the present operations of the medical laboratory system, specific requirements are
established concerning equipment records:
Records are meticulously maintained for each item of equipment that has an impact on the
results of laboratory activities. These comprehensive records include the following details,
where applicable:

a) Manufacturer and Supplier Information: Details of the manufacturer and supplier are
documented, along with sufficient information to uniquely identify each equipment item,
encompassing software and firmware details.
b) Relevant Dates: Important dates such as the receipt of the equipment, acceptance testing, and its
initiation into service are recorded.
c) Conformity Evidence: Records provide evidence that the equipment adheres to the specified
acceptability criteria.
d) Location Information: The current location of the equipment is consistently recorded.
e) Condition upon Receipt: The condition of the equipment upon receipt, whether new, used, or
reconditioned, is documented.
f) Manufacturer's Instructions: Detailed information from the manufacturer regarding equipment
operation and usage instructions is included.

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g) Preventive Maintenance Program: A comprehensive preventive maintenance program is
documented for each equipment item.
h) Maintenance Activities: Any maintenance activities performed, whether by the laboratory or an
approved external service provider, are meticulously recorded.
i) Incident and Maintenance Records: Details of any damage, malfunction, modification, or repair
of the equipment are included in the records.
j) Performance Documentation: Equipment performance records, such as calibration or
verification reports, including dates, times, and results, are consistently documented.
k) Equipment Status: The current status of the equipment, whether active, out-of-service,
quarantined, retired, or obsolete, is diligently recorded.
These records are consistently maintained and made readily available throughout the lifespan of
the equipment, in accordance with the specified duration. This approach ensures accurate
documentation, accountability, and adherence to quality standards in the medical laboratory
system.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Equipment selection, installation, handling,
maintenance and decommissioning and recall notice (WMHL/QMSP/02)
Quality Management System Procedure for Adverse Incident Reporting (WMHL/QMSP/03)

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6.5 Equipment calibration and metrological traceability
6.5.1 General
The laboratory is responsible for defining comprehensive calibration and traceability requirements. These
requirements are carefully crafted to ensure the consistent and accurate reporting of examination results
over time. The laboratory is vested with the responsibility of establishing comprehensive calibration and
traceability requirements. These requirements play a pivotal role in maintaining the consistency and
accuracy of examination results as time progresses. Calibration ensures that the measurements taken by
laboratory equipment align with established standards, guaranteeing the reliability of the reported results
For methods that involve quantitative measurements of specific analytes, the specifications are
particularly rigorous. These specifications encompass not only the calibration process but also the
metrological traceability requirements. This traceability ensures that the measurements can be linked to
internationally recognized standards, establishing a clear and auditable chain of measurement accuracy.
In cases where the methods involve qualitative assessments or quantitative measurements of
characteristics other than distinct analytes, the specifications are tailored accordingly. The laboratory
carefully defines the characteristic under assessment and outlines the necessary requirements to ensure
that the reproducibility of these assessments remains consistent over time.

6.5.2 Equipment Calibration:

In the current functioning of the medical laboratory system, specific requirements govern equipment
calibration:
The laboratory is equipped with comprehensive procedures for the calibration of equipment that holds a
direct or indirect influence over examination results. These procedures meticulously outline the following
aspects:
a) Calibration Conditions and Manufacturer's Instructions: The procedures detail the
Specific conditions for equipment usage during calibration, adhering to the manufacturer's
instructions.
b) Metrological Traceability Recording: The procedures ensure that the metrological traceability of
calibration is accurately recorded. This documentation establishes a clear link between the laboratory's
measurements and internationally recognized standards.

c) Measurement Accuracy Verification: The required measurement accuracy and the operational
functionality of the measuring system are verified at specified intervals. This regular verification
ensures that the equipment continues to provide accurate and reliable results.

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d) Calibration Status and Re-calibration Date: The procedures mandate the recording of the
calibration status and the date of re-calibration. This documentation provides an auditable trail of
the equipment's calibration history.
e) Correction Factor Management: In cases where correction factors are applied, the procedures
ensure that these factors are updated and recorded during re-calibration events.
f) Handling of Calibration Variations: Situations where calibration might have been out of control are
addressed through established procedures. These measures are designed to minimize risks to both service
operations and patient well-being.
By adhering to these requirements, the medical laboratory system ensures that its equipment remains
accurate, reliable, and capable of providing precise examination results. This approach safeguards the
integrity of the laboratory's diagnostics and contributes to maintaining high-quality patient care.

6.5.3 Metrological traceability of measurement results

In the current operations of the medical laboratory system, specific requirements govern the metrological
traceability of measurement results:

a) Establishing and Maintaining Traceability: The laboratory has a stringent process to establish
and uphold metrological traceability of its measurement results. This is achieved by creating a
meticulously documented unbroken chain of calibrations. Each calibration contributes to the
measurement uncertainty and is linked to an appropriate reference. It's noteworthy that the
laboratory may obtain information about traceability from an examination system manufacturer,
particularly if the manufacturer's system and calibration procedures are used without any
modifications.
b) Ensuring Highest Order of Traceability: The laboratory is committed to ensuring that its
measurement results are traceable to the highest possible level of traceability and as closely aligned
with the International System of Units (SI) as feasible. This traceability is achieved through two main
avenues:
— Calibration by Competent Laboratories: Measurement results achieve traceability through
calibration performed by laboratories that meet the requirements of ISO/IEC 17025. Such
laboratories are considered competent for carrying out calibrations
c) Alternative Means of Confidence: In cases where achieving traceability according to 6.5.3 a) is not
feasible, alternative approaches are employed to instill confidence in the obtained results. These
approaches encompass various strategies, including but not limited to the following:
— Reference Measurement Procedures, Specified Methods, or Consensus Standards: Measurement
results are backed by reference measurement procedures, specified methods, or consensus

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standards. These methods are clearly described and recognized for delivering results suited to their
intended application. Suitability is ensured through suitable comparisons.
— Calibration/Calibrator Measurement by Another Procedure: Another avenue involves measuring
the calibration/calibrator using a different procedure. This approach adds an additional layer of
confidence to the measurement results.
d) Genetic Examinations Traceability: In the case of genetic examinations, it's essential to establish
traceability to genetic reference sequences. This meticulous approach ensures that the genetic
examination results are accurate and align with established genetic reference standards.
e) Qualitative Methods Traceability: For qualitative methods, traceability can be demonstrated
through specific means. This involves testing known materials or previous samples that are sufficient
to showcase consistent identification and, when applicable, the intensity of the reaction.
By adhering to these requirements, the medical laboratory system ensures that its measurement
results are not only accurate but also supported by robust methods of traceability or alternative
means of confidence, as appropriate. This approach contributes to the reliability and precision of the
laboratory's diagnostics, maintaining high standards of patient care.

ASSOCIATED PROCEDURE: Quality Management System Procedure for Meteorological Traceability

& Calibration of the Equipment’s (WMHL/QMSP/04)

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6.6 REAGENTS AND CONSUMABLES
6.6.1 General
The laboratory operates with well-defined processes concerning the various aspects of reagents and
consumables: Reagents encompass a diverse range, including commercially supplied substances, materials
prepared in-house, reference materials such as calibrators and quality control materials, as well as culture
media. Consumables comprise essential items like pipette tips, glass slides, point-of-care testing (POCT)
supplies, and more. The processes encompass:
— Selection and Procurement: Thoughtful selection and procurement strategies are established to ensure
the acquisition of suitable reagents and consumables.
— Reception and Storage: Efficient procedures are in place for the reception of reagents and consumables,
followed by appropriate storage practices to maintain their integrity.
— Acceptance Testing: Rigorous acceptance testing procedures are conducted to verify the quality and
suitability of incoming reagents and consumables.
— Inventory Management: Effective inventory management procedures are implemented to monitor
stock levels, track usage, and replenish as needed
By adhering to these requirements, the medical laboratory system ensures a streamlined and reliable
supply of reagents and consumables, contributing to the accuracy, consistency, and quality of its
examination results and diagnostics

The laboratory has documented procedure for the reception, storage, acceptance, testing and inventory
management of reagents and consumables.

6.6.2 Reagents and consumables — Receipt and storage

The laboratory adheres to precise practices concerning the receipt and storage of reagents and
consumables:
— Storage as per Manufacturers' Specifications: Reagents and consumables are stored in strict
accordance with the specifications provided by their respective manufacturers. This ensures that the
integrity and quality of these materials are preserved.
— Environmental Monitoring: The laboratory monitors the environmental conditions where applicable,
ensuring that storage conditions are optimal for maintaining the quality and efficacy of reagents and
consumables.
— Verification of Receiving Facility: In cases where the laboratory isn't the receiving facility for these
materials, it undertakes the responsibility of verifying that the receiving facility possesses adequate
storage and handling capabilities. This verification guarantees that supplies are maintained in a manner
that safeguards them against damage and deterioration.

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By adhering to these requirements, the medical laboratory system ensures that reagents and consumables
are received, stored, and managed with utmost care, thus upholding the quality and reliability of its
examination results and overall diagnostics.
6.6.3 Reagents and consumables — Acceptance testing
In the ongoing operations of the medical laboratory system, the following elaboration complements the
discussed requirements on acceptance testing of reagents and consumables. The laboratory carries out
comprehensive acceptance testing for various materials:
— New Formulations of Examination Kits: Whenever there are alterations in reagents or procedures,
or in the case of new lots or shipments of examination kits, each new formulation undergoes
thorough performance verification before its utilization in examinations. This testing involves
careful comparisons against controls or known samples, wherever possible.
— Verification of Consumables: Consumables that have the potential to influence the quality of
examinations are subjected to meticulous performance verification prior to their usage. This
verification process can take various forms, including visual inspections or comparisons against
established standards. This might involve testing in the laboratory, conducting tests in an
accredited laboratory, or comparing the consumables against known standards or previously
tested samples. The laboratory is proactive in ensuring the quality of the materials it uses. It
collaborates with manufacturers or suppliers to acquire quality certificates for the materials,
adding an additional layer of assurance.
By consistently adhering to these practices, the medical laboratory system guarantees that all
reagents and consumables employed in the diagnostic process meet stringent quality standards.
This approach substantiates the accuracy, reliability, and uniformity of examination results,
underscoring the system's commitment to delivering high-quality patient care.

6.6.4 Reagents and consumables — Inventory management

In the ongoing operations of the medical laboratory system, specific requirements address the
management of reagents and consumables inventory: The laboratory operates with a well-defined
inventory management system tailored for reagents and consumables.
This system is characterized by the following practices:
— Establishing Inventory Management System: The laboratory has set up a comprehensive inventory
management system specifically designed to oversee the tracking, monitoring, and control of its reagents
and consumables.
— Segregation of Accepted and Uninspected Items: The system goes beyond mere monitoring; it
actively segregates reagents and consumables into two distinct categories. On one hand, there are those
items that have undergone thorough inspection and been accepted for usage. On the other hand, items that

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have not been inspected or accepted are kept separate. This segregation ensures that materials that have
not yet met the criteria for acceptance are clearly distinguished from those that have been approved for
use. By adhering to these requirements, the medical laboratory system ensures efficient and organized
inventory management for reagents and consumables. This approach contributes to accurate tracking,
reduces the risk of using unverified items, and ultimately maintains the quality and reliability of
examination results and diagnostics.
The laboratory has established an inventory control system for reagents and consumables which is
documented.

6.6.5 Reagents and consumables — Instructions for use

In the ongoing operations of the medical laboratory system, specific requirements address the instructions
for using reagents and consumables. The laboratory has a meticulous approach when it comes to the
utilization of reagents and consumables:
— Readily Available Instructions: Instructions governing the proper usage of reagents and consumables
are readily accessible within the laboratory. These instructions encompass guidance provided by the
manufacturers, as well as any additional information pertinent to their effective and accurate use.
— Adherence to Manufacturer's Specifications: The laboratory strictly adheres to the specifications
outlined by the manufacturers. Reagents and consumables are employed in strict accordance with these
specifications, ensuring that they are used in a manner that aligns with their intended purpose.
By following these requirements, the medical laboratory system ensures that the reagents and
consumables are employed in a manner that maximizes their efficacy, thereby contributing to the
precision, reliability, and quality of examination results and diagnostics.

6.6.6 Reagents and consumables — Adverse incident reporting

In the present operations of the medical laboratory system, specific requirements address the reporting of
adverse incidents involving reagents and consumables. The laboratory operates with a stringent approach
concerning adverse incidents involving reagents and consumables:
— Investigation and Reporting: Adverse incidents or accidents that can be directly attributed to specific
reagents or consumables are thoroughly investigated. In the event of such incidents, the laboratory takes
the responsibility to report them promptly. Reports are submitted to either the manufacturer or supplier,
or both, as well as the relevant authorities, as per the necessary requirements.
— Procedures for Manufacturer's Recalls: The laboratory is well-prepared to respond to any recalls or
notices issued by manufacturers. Well-defined procedures are in place to address such situations. The
laboratory promptly takes the recommended actions outlined by the manufacturer to address any
potential concerns.

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By adhering to these requirements, the medical laboratory system ensures that any adverse incidents or
accidents related to reagents and consumables are addressed promptly and efficiently. This approach
underscores the system's commitment to patient safety, maintaining the quality of examination results,
and ensuring adherence to industry standards.

6.6.7 Reagents and consumables — Records

In the current operations of the medical laboratory system, specific requirements govern the maintenance
of records for reagents and consumables. The laboratory meticulously maintains records concerning each
reagent and consumable that contributes to the performance of examinations. These records encompass
vital information, including but not limited to:
a) Identification: The identity of each reagent and consumable is meticulously recorded.
b) Manufacturer's Information: Comprehensive details from the manufacturer are documented,
encompassing instructions, the manufacturer's name, and batch code or lot number.
c) Key Dates: Essential dates are recorded, such as the date of receipt, the condition of the item upon
receipt, its expiry date, date of first use, and when applicable, the date when the reagent or consumable
was taken out of service.
d) Acceptance Records: Detailed records confirming the reagent's or consumable's initial acceptance for
use, as well as any ongoing confirmations, are systematically maintained.
For reagents that are prepared or completed in-house, the records encompass the above-mentioned
information and more.
— Preparation Details: If the laboratory prepares or completes reagents in-house, the records include
reference to the individuals responsible for the preparation. Furthermore, the dates of preparation and
expiry are meticulously documented.
By adhering to these requirements, the medical laboratory system ensures that comprehensive records
are maintained for each reagent and consumable, offering a clear and traceable account of their usage,
history, and status. This meticulous approach contributes to the accuracy, reliability, and overall quality of
examination results and diagnostics.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for storage and Inventory Management
(WMHL/QMSP/05)
Quality Management System Procedure for Consumables — Adverse Incident Reporting
(WMHL/QMSP/06)

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6.7 SERVICE AGREEMENTS
6.7.1 AGREEMENTS WITH LABORATORY USERS
In the ongoing operations of the medical laboratory system, specific requirements govern the establishment
and management of service agreements. The laboratory operates with a well-defined procedure for
establishing and periodically reviewing agreements related to providing laboratory activities to its users:

a) Agreement Specification: The procedure ensures that the requirements for laboratory
activities are adequately specified within the agreements. This guarantees that both parties have a
clear understanding of what is expected.
b) Capability and Resources: Prior to entering into agreements, the laboratory verifies that it
possesses the necessary capability and resources to fulfill the specified requirements. This
proactive step ensures that the laboratory can deliver the expected services with the highest
standards of quality.
c) Referral and Consultant Communication: When relevant, the laboratory communicates specific
activities to be performed by referral laboratories or consultants. This ensures transparency and
clarity for all parties involved.
Moreover:

— Change Communication: The laboratory consistently informs laboratory users of any changes
made to an existing agreement that could potentially impact examination results. This commitment
to communication fosters transparency and helps maintain the quality of services provided.

— Review Records: The laboratory diligently retains records of the agreement reviews. These
records encompass any significant changes made during the review process, providing a documented
history of the agreements and any adjustments that have been made over time. By adhering to these
requirements, the medical laboratory system ensures that its service agreements are thoughtfully
established, periodically evaluated, and transparently communicated. This approach contributes to
effective collaboration with laboratory users, the delivery of high-quality services, and the consistent
adherence to industry standards.

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6.7.2 Agreements with POCT operators
In the current functioning of the medical laboratory system, specific requirements address service
agreements with Point-of-Care Testing (POCT) operators. Service agreements forged between the
laboratory and other segments of the organization utilizing laboratory-supported POCT are characterized
by meticulous attention to responsibilities and authorities:
— Specified Responsibilities and Authorities: These service agreements are meticulously designed to
clearly outline and specify the responsibilities and authorities of each party involved. This ensures that all
parties have a comprehensive understanding of their roles within the POCT framework.
— Effective Communication: These agreements prioritize effective communication by ensuring that the
roles, responsibilities, and authorities are communicated clearly and concisely to all relevant stakeholders.
This proactive approach guarantees that there are no ambiguities and that everyone is aligned.
By adhering to these requirements, the medical laboratory system ensures that service agreements with
POCT operators are structured in a manner that promotes clarity, accountability, and effective
collaboration. This approach contributes to seamless POCT operations, accurate results, and overall patient
safety and care.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Review of Service Agreements (WMHL/QMSP/07)

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6.8 EXTERNALLY PROVIDED PRODUCTS AND SERVICES
6.8.1 General
In the ongoing operations of the medical laboratory system, specific requirements address the management
of externally provided products and services. The laboratory operates with a comprehensive approach
concerning externally provided products and services that impact laboratory activities:
— Suitability of Externally Provided Products and Services: The laboratory ensures that externally
provided products and services are suitable for their intended purpose when they fall under these
categories:

a) Incorporation into Laboratory Activities: Products and services intended to be incorporated into the
laboratory's own activities undergo a suitability assessment to ensure they meet the required standards.
b) Direct Provision to Users: When the laboratory directly provides products and services to users, as
received from external providers, it verifies their suitability before delivery.
c) Supporting Laboratory Operation: Products and services used to support the operation of the
laboratory are scrutinized for suitability.
— Collaboration for Fulfillment: Sometimes, fulfilling this requirement necessitates collaboration with
other organizational departments or functions. This ensures that all aspects of externally provided
products and services are properly evaluated and addressed.
— Range of Services: These externally provided products and services encompass a wide range, such as
sample collection services, calibration services, maintenance services for facilities and equipment,
External Quality Assurance (EQA) programs, as well as services from referral laboratories and
consultants.
By following these requirements, the medical laboratory system ensures that externally provided
products and services are carefully evaluated for their suitability and alignment with the laboratory's
activities. This meticulous approach contributes to the overall quality, accuracy, and effectiveness of the
laboratory's operations and services.

6.8.2 Referral laboratories and consultants

In the ongoing operations of the medical laboratory system, specific requirements address the
collaboration with referral laboratories and consultants. The laboratory operates with a structured
approach when engaging referral laboratories and consultants, ensuring effective communication and
collaboration:
— Communicating Requirements: The laboratory proactively communicates its specific requirements
to referral laboratories and consultants who provide interpretations and advice. These requirements
encompass:

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a) Procedures, Examinations, Reports, and Consulting Activities: Clear guidelines are
communicated regarding the procedures, examinations, reports, and consulting activities that
are expected to be provided by the referral laboratories and consultants.
b) Management of Critical Results: Detailed instructions are provided for the management of
critical results, outlining the necessary actions in case of such outcomes.
c) Personnel Qualifications and Competence: Any essential personnel qualifications and
demonstrations of competence are conveyed to ensure the highest quality of services
— Referring Laboratory Responsibility: Unless the agreement specifies otherwise, the referring
laboratory, rather than the referral laboratory, holds the responsibility for ensuring that
examination results from the referral laboratory are promptly provided to the requester.
— Maintaining a List: The laboratory maintains a comprehensive list of all referral laboratories and
consultants, promoting transparency and accessibility of information.
By adhering to these requirements, the medical laboratory system ensures effective
collaboration with referral laboratories and consultants. This approach promotes clear
communication, standardized procedures, and the timely provision of accurate examination
results, ultimately enhancing the quality and reliability of the laboratory's services.

6.8.3 Review and approval of externally provided products and services

In the ongoing operations of the medical laboratory system, specific requirements address the review
and approval of externally provided products and services. The laboratory operates in accordance with
established procedures with a systematic approach to ensure the effective review and approval of
externally provided products and services:
a) Defining, Reviewing, and Approving Requirements: The laboratory has established
procedures in place to define, review, and approve its requirements for all externally
provided products and services. This comprehensive process ensures that the laboratory's
needs and standards are clearly communicated to external providers.
b) Criteria for Qualification and Selection: Clear criteria are defined for the qualification,
selection, evaluation of performance, and re-evaluation of external providers. These criteria
enable the laboratory to assess and maintain a high standard of service from external sources.
c) Referral of Samples: The laboratory establishes protocols for the referral of samples,
ensuring that the process is well-defined and adheres to quality standards.
d) Conformance to Requirements: Procedures are in place to ensure that externally provided
products and services conform to the laboratory's established requirements or, when
applicable, the relevant requirements of this document. This verification process guarantees
that the products and services meet the necessary quality and performance standards before
they are utilized or provided to users.
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e) Actions Based on Performance Evaluations: The laboratory is proactive in taking
necessary actions based on evaluations of the performance of external providers. This
ensures continuous improvement and accountability in the utilization of externally provided
products and services.
By adhering to these requirements, the medical laboratory system ensures that all externally
provided products and services are thoroughly evaluated, approved, and aligned with the
laboratory's quality standards. This approach contributes to consistent and reliable
operations, ultimately enhancing patient care and safety.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Externally Provided Products and
Services selection, review and evaluation (WMHL/QMSP/08)

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7.0 PROCESS REQUIREMENTS:
7.1 General
In the ongoing operations of the medical laboratory system, specific requirements address the process
requirements. The laboratory operates with a proactive approach to identifying and managing potential
risks to patient care throughout the pre-examination, examination, and post-examination processes:
— Risk Identification and Mitigation: The laboratory systematically identifies potential risks that could
impact patient care within the various stages of the examination process. These identified risks undergo a
comprehensive assessment, and appropriate mitigation strategies are put in place to minimize their
impact. The goal is to reduce potential harm to patients.
— Communication of Residual Risk: Residual risks that remain even after mitigation efforts are
communicated to users as appropriate. Transparency ensures that users are informed about any residual
risks associated with the laboratory's processes.
— Monitoring and Evaluation: The laboratory continuously monitors the identified risks and the
effectiveness of the mitigation processes. The extent of monitoring and evaluation is determined by the
potential harm that these risks could cause to patients. This dynamic approach ensures that risks are
consistently assessed and managed.
— Identifying Opportunities for Improvement: The laboratory also actively identifies opportunities to
enhance patient care. These opportunities are carefully assessed, and a structured framework is developed
to manage and implement improvements.
By adhering to these requirements, the medical laboratory system takes a proactive stance in identifying,
assessing, and mitigating potential risks to patient care. Simultaneously, it focuses on identifying
opportunities to enhance patient care quality. This comprehensive approach contributes to a safe and
reliable healthcare environment, promoting patient safety and continuous improvement in the laboratory's
processes.

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7.2 PRE-EXAMINATION PROCESS
7.2.1 General
In the current functioning of the medical laboratory system, the following requirements pertain to pre-
examination activities.
The Laboratory Procedures: The laboratory ensures that well-defined procedures are in place for all pre-
examination activities. These procedures are accessible to personnel involved in relevant roles. This
accessibility facilitates consistent and standardized practices throughout the pre-examination processes.
Influence on Examination Outcome: The laboratory acknowledges that pre-examination processes hold
the potential to impact the final results of the intended examination. Given this critical relationship,
meticulous attention is paid to pre-examination activities to ensure that they are conducted accurately and
in accordance with established procedures.
By adhering to these requirements, the medical laboratory system ensures that pre-examination activities
are conducted systematically, following established procedures. This approach contributes to the overall
accuracy, reliability, and integrity of the examination results, promoting patient safety and quality
healthcare services.
7.2.2 Laboratory information for patients and users
In the ongoing operations of the medical laboratory system, the following requirements relate to providing
laboratory information to patients and users:
Appropriate Information for Users and Patients: The laboratory ensures that it has relevant and
accurate information available for its users and patients. This information is designed to provide a
comprehensive understanding of the laboratory's activities and the expectations from users.
Comprehensive Scope of Information: The information provided encompasses various aspects, including:
a) Location and Contact Details: The laboratory offers clear details about its location,
operating hours, and contact information. This helps users and patients access the laboratory
efficiently and communicate when necessary.
b) Sample Collection Procedures: The laboratory outlines the procedures for requesting and
collecting samples. This information is crucial for users and patients to follow proper
protocols when providing samples for examination.
c) Scope of Activities and Result Availability: Users receive insights into the laboratory's
scope of activities, as well as the expected timeframes for result availability. This
transparency allows users to align their expectations accordingly.
d) Advisory Services: Information regarding the availability of advisory services is provided.
This helps users seek guidance or clarification when required.
e) Patient Consent Requirements: The laboratory communicates any requirements for
obtaining patient consent before conducting examinations.

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f) Impact Factors: Factors that can significantly influence the examination's performance or
result interpretation are communicated. This empowers users and patients to understand
potential variables.
g) Complaint Process: The laboratory's complaint process is clearly outlined, enabling users
and patients to express concerns or provide feedback if needed.
By fulfilling these requirements, the medical laboratory system ensures that users and
patients have access to comprehensive and relevant information. This transparency fosters
trust, supports informed decision-making, and enhances the overall user experience within
the healthcare environment.

7.2.3 Requests for providing laboratory examinations

7.2.3.1 General
a) Request as an Agreement: Each examination request received by the laboratory is treated as an
agreement between the laboratory and the requester. This underlines the significance of accurate and
mutually understood communication.
b) Comprehensive Examination Request: The examination request is structured to provide
comprehensive information. This ensures:
— Traceability and Patient Connection: The request guarantees unequivocal traceability of the patient
to both the request and the sample, minimizing any ambiguity in the process.
— Requester Identity and Contact: The identity and contact details of the requester are included,
facilitating effective communication and interaction between the laboratory and the requester.
— Requested Examinations: The specific examinations requested are clearly indicated, leaving no room
for misinterpretation.
— Informed Advice and Interpretation: The information provided enables the laboratory to offer well-
informed clinical and technical advice, as well as accurate interpretation of the results.
c) Format Flexibility: The laboratory has the flexibility to receive examination request information in a
format or medium that is considered suitable by the laboratory and acceptable to the user. This
adaptability accommodates different preferences and technological capabilities.
d) Clarification for Patient Care: In situations where it is deemed essential for patient care, the
laboratory engages in communication with users or their representatives. This communication serves to
clarify and enhance the understanding of the user's request, contributing to accurate and relevant
examinations.
By adhering to these requirements, the medical laboratory system ensures that examination requests are
handled with precision, enabling effective communication, accurate testing, and informed decision-
making for patient care.

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7.2.3.2 Oral requests

Managing Oral Requests: The laboratory has a structured procedure for effectively managing oral
requests for examinations. This procedure ensures that oral requests are properly documented and
managed in a systematic manner.
Documentation Confirmation: Upon receiving an oral request for an examination, the laboratory
promptly generates documented confirmation of the request. This confirmation serves as a crucial record,
validating the initiation of the request.
Time-bound Submission: The laboratory mandates that the documented confirmation of the oral request
be submitted to the laboratory within a specific timeframe. This ensures that the oral request is officially
recognized and processed in a timely manner.
By adhering to these requirements, the medical laboratory establishes a systematic approach to handling
oral requests for examinations, ensuring their proper documentation and efficient processing within
defined timeframes

7.2.4 Primary sample collection and handling

7.2.4.1 General
Within the medical laboratory framework, the following requirements are in place for the collection and
handling of primary samples:
Established Procedures: The laboratory has well-defined procedures governing the collection and
handling of primary samples. These procedures ensure consistency and accuracy in the collection process.
Information Dissemination: Relevant information regarding sample collection is made available to
individuals responsible for carrying out this process. This ensures that personnel are well-informed and
can execute collection procedures accurately.
Deviations Recording: In the event of any deviation from the established collection procedures, such
deviations are meticulously documented. This recording includes comprehensive information about the
nature of the deviation.
Risk Assessment and Communication: For cases where deviations occur, the laboratory conducts a
thorough assessment of potential risks and the impact on patient outcomes. This assessment is recorded
and communicated to the appropriate personnel, ensuring transparency and informed decision-making.
Regular Review of Requirements: The laboratory undertakes periodic reviews of the sample volume,
collection devices, and preservatives for all applicable sample types. This review guarantees that the
appropriate amount of sample is collected to preserve the analyte, preventing both insufficient and
excessive collection.

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By adhering to these requirements, the medical laboratory ensures the integrity of the sample collection
and handling processes, promoting accurate and reliable results while maintaining patient safety and
quality care.
7.2.4.2 Information for pre-collection activities
In the medical laboratory context, the following requirements outline the procedures for providing
information and instructions related to pre-collection activities.
Comprehensive Guidance: The laboratory is responsible for furnishing comprehensive information
and instructions for pre-collection activities. These instructions are detailed enough to safeguard the
integrity of the collected sample.
a) Patient Preparation: Clear instructions are provided for the preparation of patients, caregivers, and
sample collectors. These instructions ensure that all parties involved are well-informed and
equipped for a successful sample collection process.
b) Sample Details and Containers: Specifics regarding the type and quantity of the primary sample to
be collected are outlined. Descriptions of the appropriate containers and any required additives are
provided. If applicable, the order in which multiple samples are to be collected is also clarified.
c) Special Collection Timing: In cases where special timing is pertinent to the collection process,
relevant instructions are conveyed. This ensures that samples are collected at the optimal time for
accurate results.
d) Clinical Relevance: For sample collection, examination performance, or result interpretation,
clinical information that may have an impact is shared. This could include details such as the
patient's drug history.
e) Unambiguous Labelling: Instructions for proper sample labelling are provided to ensure
unequivocal identification of the patient, the source and site of the sample. This is particularly crucial
when multiple samples are collected from the same patient, including multiple tissue pieces or slides.
f) Sample Acceptance Criteria: The laboratory outlines its specific criteria for accepting or rejecting
samples based on the requested examinations. This clarity ensures that the collected samples meet
the necessary standards for analysis.
By adhering to these requirements, the medical laboratory maintains a structured approach to pre-
collection activities, promoting accurate results and patient safety while upholding quality standards.

7.2.4.3 Patient consent

The medical laboratory adheres to the following requirements regarding patient consent:
a) Informed Consent: The laboratory ensures the acquisition of informed consent from the patient for
all procedures performed on them. In routine laboratory procedures, patient consent is typically
inferred when the patient willingly undergoes the sample collection process, such as venipuncture.
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b) Special Procedures: For procedures that are more invasive or carry an elevated risk of
complications, a more detailed explanation may be necessary. In some instances, recorded consent
might be required. This approach guarantees that patients are fully informed and engaged in
procedures that might impact them significantly.
c) Emergency Situations: In situations where obtaining explicit consent is not feasible due to
emergencies, the laboratory has the prerogative to perform necessary procedures in the best interest
of the patient. This allows for prompt action while ensuring the patient's welfare.
By adhering to these guidelines, the medical laboratory maintains ethical and responsible practices
in securing patient consent, ensuring transparency and patient well-being throughout the
examination process.

7.2.4.4 Instructions for collection activities

The medical laboratory has established comprehensive procedures to guide collection activities,
ensuring the safe, accurate, and clinically sound process of sample collection and pre-examination
storage. These procedures encompass the following aspects.
a) Patient Identity Verification: The laboratory ensures that the patient's identity is verified before
collecting a primary sample. This verification step guarantees that the collected sample is accurately
associated with the respective patient.
b) Pre-Examination Requirements: Clear guidelines are provided to verify and document pre-
examination requirements that patients must adhere to. This includes details such as fasting status,
medication history (time of last dose or cessation), and scheduled collection times.
c) Primary Sample Collection: Detailed instructions are outlined for the proper collection of primary
samples. These instructions encompass comprehensive descriptions of the primary sample
containers and any necessary additives. Furthermore, the sequence for sample collection is specified
when relevant.
d) Labelling and Documentation: The laboratory emphasizes meticulous labelling of primary
samples, ensuring an unequivocal link between the collected sample and the patient.
e) Recording the Identity: This process also involves documenting the identity of the individual
collecting the sample, the collection date, and, when applicable, the collection time.
f) Sample Separation: When necessary, the laboratory provides explicit instructions for the
separation or division of primary samples.
g) Sample Stabilization Additionally, procedures are defined to stabilize and maintain proper storage
conditions for collected samples until they are transported to the laboratory.
h) Safe Disposal: Stringent procedures are established for the safe disposal of materials used during
the sample collection process. These procedures prioritize safety measures and environmentally
responsible disposal practices.
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Through these meticulous instructions, the medical laboratory maintains the integrity of the sample
collection process, safeguarding the well-being of patients and the accuracy of subsequent
examination results.

7.2.5 Sample transportation

a) Instructions for Timely and Safe Transportation:
I. The laboratory provides detailed instructions for packaging samples to ensure their safe
transportation. These instructions encompass proper containment and labeling to
prevent any damage or contamination during transit.
II. Instructions include guidelines for maintaining an appropriate time interval between
sample collection and receipt at the laboratory. This ensures that samples reach the
laboratory within a timeframe suitable for the requested examinations.
III. The laboratory emphasizes the importance of maintaining the specified temperature
interval during sample transportation. This temperature control safeguards the
integrity of samples and their suitability for accurate analysis.
IV. Specific requirements, such as the use of designated preservatives, are outlined to
guarantee the integrity of samples during transportation.

b) Immediate Notification of Compromised Sample Integrity: In situations where the integrity

of samples is compromised, leading to potential risks for the carrier or the general public, the
responsible transportation organization is promptly notified. Immediate measures are
implemented to mitigate the identified risk and prevent its recurrence.

c) Evaluation of Sample Transportation Systems: The laboratory establishes a comprehensive

system for sample transportation and periodically evaluates its adequacy. This evaluation
ensures that the transportation system remains efficient, secure, and aligned with the
laboratory's commitment to accurate and reliable examination outcomes. Through these
measures, the laboratory assures that the transportation of samples is a well-regulated process,
preserving the integrity of samples and maintaining the safety of all involved parties.
7.6.2 Sample receipt
7.2.6.1 Sample Receipt Procedure
The medical laboratory has established comprehensive procedures on sample receipt. These
procedures encompass the following aspects

a) Unwavering Traceability of Samples: The laboratory maintains a meticulous procedure for sample
receipt that guarantees the unequivocal traceability of each sample. This traceability is achieved

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through a combination of the request information and precise labeling. Samples are linked to a uniquely
identified patient and, where applicable, the specific anatomical site.
b) Acceptance and Rejection Criteria: Clear criteria for the acceptance and rejection of samples are
an integral part of the procedure. Samples that meet these criteria are accepted for processing, while
those that do not meet the acceptability standards are promptly rejected.
c) Recording Date and Time of Receipt: When relevant, the date and time of sample receipt are
diligently recorded. This timestamp aids in tracking the sample's journey through the laboratory
d) Recording the Receiving Personnel's Identity: The procedure entails recording the identity of the
individual responsible for receiving the sample when this information is pertinent.
e) Evaluation by Authorized Personnel: Upon receipt, authorized personnel conduct a thorough
evaluation of the received samples. This evaluation ensures that the samples align with the
acceptability criteria relevant to the requested examination(s).
f) Handling of Urgent Samples: Instructions for managing samples marked as urgent are detailed
within the procedure. These instructions encompass special labeling, expedited transport, rapid
processing methods, designated turnaround times, and specific reporting criteria that must be adhered
to.
g) Maintaining Traceability of All Sample Portions: The procedure underscores the importance of
maintaining unwavering traceability of all portions derived from the original sample. This meticulous
traceability ensures that each portion can be unequivocally linked back to the source sample.
Through these comprehensive measures, the laboratory establishes a robust sample receipt procedure
that upholds traceability, quality, and compliance with acceptability standards for all received samples.

7.2.6.2 Managing Sample Acceptance Exceptions

a) Prioritizing Patient Well-being: The laboratory has established a well-defined process
that places the paramount interests of the patient at the forefront of all decision-making
processes. This especially applies when a sample is at risk of compromise due to various
factors, which may include:
i. Incorrect Patient or Sample Identification: Addressing situations where errors in
patient or sample identification have occurred.
ii. Sample Instability: Managing instances where sample stability has been
jeopardized, often due to delays during transportation.
iii. Incorrect Storage or Handling Temperature: Ensuring proper handling and
storage temperatures are maintained for samples, and taking action when
deviations occur.
iv. Inappropriate Containers: Monitoring and rectifying situations where unsuitable
containers have been used, compromising sample preservation.
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v. Insufficient Sample Volume:
a) Dealing with cases where the sample volume falls below the required threshold.
In all of these scenarios, the laboratory's primary focus remains safeguarding
patient well-being and ensuring the integrity of the testing process.

b) Acceptance of Compromised Clinically Critical or Irreplaceable Samples:

When a sample is deemed clinically critical or irreplaceable, and it is accepted
despite the identified compromise, the laboratory follows a stringent process. This
process involves a thorough assessment of the risk to patient safety.
Subsequently, if such a sample is accepted for analysis, the final report will
explicitly indicate the nature of the problem associated with the sample.
Additionally, where applicable, the report provides guidance on interpreting
results with caution, acknowledging the potential impact of the compromised
sample on the outcome.
By adhering to this meticulous process, the laboratory ensures that the patient's
well-being and safety remain paramount, even in scenarios where sample
compromise may have occurred.

7.2.5 Pre-examination handling, preparation, and storage

7.2.7.1 Sample protection
The laboratory currently has procedures and appropriate facilities in place for securing patient
samples. This ensures the integrity of samples and effectively prevents any potential loss or
damage during handling, preparation, and storage.
7.2.7.2 Criteria for additional examination requests:
The laboratory procedures specify time limits for requesting additional examinations on the
same sample. This ensures that requests for additional examinations are made within the
defined time frames.
7.2.7.3 Sample stability:
The laboratory currently specifies and monitors the time between sample collection and the
performance of the examination, considering the stability of the analyte in a primary sample.
This practice ensures that examinations are conducted with samples that meet stability
criteria.

ASSOCIATED PROCEDURE: Quality Management System Procedure for Pre examination

procedure (WMHL/QMSP/09)

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7.3 Examination processes
7.3.1 Operating Guidelines
a) Validation of Examination Methods: The laboratory carefully chooses and applies examination
methods that have undergone thorough validation processes, ensuring their suitability for precise clinical
examination in patient testing scenarios. Notably, preference is given to methods specified in the
instructions for in vitro diagnostic medical devices, established textbooks, peer-reviewed literature,
international and national consensus standards or guidelines, and regional regulations.
b) Alignment of Performance Specifications: Performance specifications for each examination method
are closely aligned with the intended purpose of the examination, taking into account their impact on
patient care.
c) Up-to-Date Documentation: All pertinent documentation, including procedures, guidelines, manuals,
and reference materials pertaining to laboratory operations, are regularly updated and readily accessible
to personnel, as outlined in 8.3.
d) Adherence to Established Protocols: Personnel diligently follow established procedures, and the
identities of individuals involved in significant roles within the examination processes are meticulously
recorded. This includes operators conducting point-of-care testing (POCT).
e) Periodic Examination Method Evaluation: Authorized personnel periodically assess the suitability of
the examination methods offered by the laboratory to ensure they align with the clinical requirements of
incoming requests.
7.3.2 Verification of examination methods
a) Verification Procedure for Examination Methods: In our medical laboratory, we maintain a stringent
procedure to verify our capability to perform examination methods accurately before their introduction for
use. This verification process is a crucial step to guarantee that we can achieve the required performance
levels as specified by the manufacturer or the method itself. Our commitment to thorough verification
procedures ensures the accuracy and reliability of the diagnostic results we provide, ultimately benefiting
healthcare professionals and patients who rely on our services.
b) Alignment with Intended Use: We prioritize aligning the performance specifications of examination
methods with the intended use of the examination results. During the verification process, we confirm that
the performance specifications of the examination method are directly relevant to the clinical requirements
and intended applications of the results. This alignment is essential to tailor our diagnostic services to meet
the specific needs of patients and healthcare providers, enhancing the clinical significance of our offerings.

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c) Ensuring Comprehensive Verification: Our laboratory places significant emphasis on ensuring the
comprehensiveness of our verification of examination methods. Recognizing that the validity of results is
paramount for clinical decision-making, we take proactive measures to ensure our verification processes
are thorough. This approach guarantees that the results we produce are consistently valid and reliable,
instilling confidence in the healthcare professionals and patients who depend on our services. Our
dedication to comprehensive verification is integral to our mission of providing accurate and clinically
valuable diagnostic information.
d) Expert Review and Documentation: In our medical laboratory, only personnel with the requisite
authorization and competence are entrusted with the critical task of reviewing the results obtained from
the verification process. These skilled professionals meticulously assess the verification outcomes,
ensuring that they align with the specified requirements. Their expertise and diligence in this review
process are fundamental to maintaining the high standards of accuracy and reliability that define our
laboratory.
e) Adapting to Method Revisions: We acknowledge that methods used in clinical diagnostics can
undergo revisions by the issuing bodies. In such cases, our laboratory is committed to adapting and
ensuring that our verification remains up-to-date. When a method is revised, we promptly initiate a re-
verification process to the extent necessary. This proactive approach allows us to continue delivering
accurate and clinically valuable results, keeping pace with advancements in diagnostic methodologies.
f) Comprehensive Verification Records: At our laboratory, we maintain comprehensive
records of the verification process. These records include:
I. Performance Specifications: We meticulously document the performance
specifications that need to be achieved for each examination method.
II. Results Obtained: Our records include detailed information on the results
obtained during the verification process, providing a clear picture of the method's
performance.
III. Statement of Compliance: We maintain a statement that explicitly outlines
whether the performance specifications were met during the verification process.
If any discrepancies are identified, we also document the corrective actions taken
to address them. These records serve as a vital reference for quality control and
continuous improvement within our laboratory, ensuring the reliability and
clinical relevance of our diagnostic services.

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7.3.3 Validation of Examination Methods
This element ensures that examination methods used within the laboratory are fit for their intended
purpose, accurate, and reliable. It helps to maintain the quality and integrity of examination results,
which are crucial for clinical decision-making.
a) Validation Process: Within our medical laboratory's management system, the validation of
examination methods is a foundational requirement aimed at ensuring the reliability and
accuracy of the diagnostic results we produce. We meticulously validate examination
methods from various sources, as outlined in the following subpoints:
I. Laboratory Designed or Developed Methods: We recognize that some of the
examination methods used within our laboratory are developed in-house. These methods
are rigorously validated to verify their precision, accuracy, and clinical relevance. Our
validation process for such methods involves extensive testing and data analysis to
ensure they meet the specified performance criteria.
II. Methods Used Outside Their Originally Intended Scope: Our management system
acknowledges that examination methods might sometimes be applied beyond their
original intended scope. This could involve using third-party reagents on instruments not
initially validated for these components or performing tests outside the manufacturer's
recommended instructions for use. In such cases, where no validation data is available,
we undertake a thorough validation process. This process ensures that the modified
method remains reliable and relevant for clinical decision-making while adhering to our
laboratory's quality standards.
III. Validated Methods Subsequently Modified: In cases where validated methods undergo
modifications, we implement a comprehensive validation process to assess the impact of
these changes. This validation procedure ensures that the modified method continues to
meet the specified performance requirements. We are committed to maintaining the
consistency and clinical validity of our examination results, even when changes are
introduced to validated methods.
b) Extensive Validation for Intended Use Confirmation: In our medical laboratory's
management system, we approach the validation of examination methods with the utmost
thoroughness. This commitment is driven by our unwavering dedication to providing
accurate and reliable diagnostic results. Our validation process is as extensive as necessary
to confirm, through the presentation of objective evidence in the form of performance
specifications, that the specific requirements for the intended use of each examination have
been fulfilled. This meticulous approach ensures that our examination methods consistently
meet the stringent criteria essential for clinical decision-making.

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c) Competent Personnel Review and Documentation: Our management system places great
emphasis on the competence and authorization of our personnel. Qualified individuals with
the appropriate authorization and expertise are responsible for reviewing the validation
results. They meticulously examine the evidence to ensure that the results align with the
specified requirements. This review process, conducted by experienced professionals, is an
essential component of our commitment to maintaining the highest standards of quality and
accuracy.
d) Evaluation of Proposed Changes: When changes are proposed to a validated examination
method, we prioritize patient safety and the clinical impact of such modifications. Our
management system mandates a comprehensive evaluation of the clinical impact of these
proposed changes. This evaluation considers the potential consequences on patient care and
diagnostic accuracy. Based on this assessment, a decision is made regarding whether to
implement the modified method. Our priority is to ensure that any changes introduced do
not compromise the clinical validity and reliability of our examination results.
e) Comprehensive Records Retention: As part of our robust quality management system, we
maintain meticulous records of the validation process. These records are a testament to our
commitment to transparency and accountability. Specifically, we retain the following records
of validation:
I. Validation Procedure: We document the validation procedure used, providing clear
insight into the steps and methodologies applied during the validation process.
II. Specific Requirements for Intended Use: We record the specific requirements
established for the intended use of each examination method. This documentation
ensures that our validation aligns with the unique demands of each test.
III. Performance Specifications: We determine the performance specifications of each
validated method. These specifications are critical in assessing the reliability and
accuracy of examination results.
IV. Results Obtained: We maintain records of the results obtained during the validation
process. These results serve as objective evidence of the method's performance
V. Statement on Method Validity: Finally, we provide a statement on the validity of each
examination method. This statement offers a comprehensive overview of the method's
fitness for its intended use, affirming its clinical relevance and accuracy.
Our management system's commitment to these rigorous validation processes ensures that all
examination methods utilized in our laboratory consistently deliver precise, clinically relevant,
and reliable results. These practices are central to our mission of providing healthcare
professionals with the highest quality diagnostic information to support patient care and clinical
decision-making.
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7.3.4 Evaluation of measurement uncertainty (MU)
a) Assessing Measurement Uncertainty: In our medical laboratory, we recognize that all
measurements inherently possess a degree of bias and imprecision. As a fundamental aspect of
our quality management system, we diligently evaluate the Measurement Uncertainty (MU)
associated with the values of measured quantities. This evaluation ensures that the MU is
commensurate with the intended use of the measurement, where relevance is established.
Moreover, our laboratory takes a proactive approach by comparing the calculated MU against
defined performance specifications, and the outcomes of these comparisons are meticulously
documented.
b) Ongoing Review: The evaluation of MU is not a one-time endeavor; instead, it's a continual
process. Our laboratory has established a systematic practice of regularly reviewing MU
evaluations. This periodic review is critical for ensuring that our measurement processes
consistently meet the established standards of accuracy and reliability.
c) Rationale for Exclusions: In situations where it is not feasible or applicable to estimate the
Measurement Uncertainty for specific examination procedures, we adhere to rigorous
documentation practices. Any such exclusion from the estimation of MU is accompanied by a
well-documented rationale, providing transparency and accountability in our quality assurance
processes.
d) Accessibility to Users: As part of our commitment to transparency and quality assurance, we
make MU information readily available to our laboratory users upon request. This ensures that
our stakeholders have access to essential data that can aid in the interpretation and
understanding of measurement results, further enhancing the overall quality of our services.
e) Responding to User Inquiries: In our medical laboratory, we place a high value on ensuring
that our users have access to comprehensive information regarding Measurement Uncertainty
(MU). When users approach us with inquiries related to MU, our response is meticulous and
considerate. We take into account not only the inherent uncertainties associated with our
measurement processes but also other pertinent sources of uncertainty. This holistic approach
provides users with a well-rounded understanding of the factors influencing the accuracy and
reliability of our results, including considerations of biological variation where applicable.
f) Estimating MU for Qualitative Results: In cases where the qualitative outcome of an
examination is derived from a test that produces quantitative output data, and the result is
expressed as positive or negative based on a predefined threshold, we take special care to
estimate the MU associated with the output quantity. This estimation process involves the use of
representative positive and negative samples, ensuring that even in qualitative assessments, the
influence of uncertainty is accounted for.

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g) Addressing Qualitative Results: For examinations that yield qualitative results, we go a step
further in managing uncertainty. We consider the Measurement Uncertainty not only in the final
result but also at intermediate measurement steps and within Internal Quality Control (IQC)
results that generate quantitative data. This comprehensive approach extends to key and high-
risk portions of the examination process. By doing so, we enhance the robustness and reliability
of our qualitative assessments.
h) MU in Method Verification and Validation: In our laboratory, we acknowledge the critical
role of Measurement Uncertainty in the verification and validation of examination methods.
When relevant, MU is taken into careful consideration during these processes. This proactive
approach ensures that our methods meet established standards for accuracy and reliability,
further bolstering the quality of our services.

7.3.5 Biological reference intervals and clinical decision limits

a) Specifying Reference Intervals and Limits: In our medical laboratory, we adhere to
stringent practices concerning Biological Reference Intervals and Clinical Decision Limits.
These vital parameters, crucial for the interpretation of examination results, are meticulously
specified and communicated to our users.
 Patient-Centric Approach: When defining these intervals and limits, we tailor them to the
specific patient population we serve. We carefully consider the potential risks to our
patients to ensure that the intervals and limits are both relevant and safe.
 Use of Manufacturer Values: In certain instances, we rely on biological reference values
provided by manufacturers. However, we don't take this data at face value. Instead, we
rigorously verify the population base from which these values are derived, ensuring their
acceptability and appropriateness for our laboratory's use.
b) Regular Reviews: We understand that healthcare is an evolving field. Consequently, our
Biological Reference Intervals and Clinical Decision Limits are subjected to regular reviews.
Any modifications or updates to these values are promptly communicated to our users,
ensuring that our interpretations remain current and accurate.
c) Adapting to Method Changes: In the event that changes are made to our examination or pre-
examination methods, we conduct a thorough assessment of their impact on associated
Biological Reference Intervals and Clinical Decision Limits. If applicable, we promptly
communicate these changes to our users to maintain transparency and support informed
decision-making.
d) Genetic Examinations: For examinations designed to identify the presence or absence of
specific characteristics, such as genetic examinations, the Biological Reference Interval is
aligned with the characteristic under investigation. In these cases, we ensure that the
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reference interval accurately reflects the parameter being identified. This is crucial for the
precision and clinical relevance of our genetic testing services.

7.3.6 Documentation of Examination Procedures

a) Extent of Documentation The laboratory ensures that examination procedures are
thoroughly documented to guarantee consistent activities and valid results. This comprehensive
documentation process is crucial for maintaining the quality and integrity of all laboratory
activities.
b) Language and Accessibility All procedures are written in a language that can be easily
understood by laboratory personnel. This ensures that every team member can access and
follow the procedures effectively. Procedures are also made available in appropriate locations
throughout the laboratory for easy reference.
c) Abbreviated Documentation Abbreviated document content always corresponds to the full
procedure. Quick-reference materials, such as working instructions, flow process diagrams, or
similar systems, summarize key information for use at workbenches. However, they must
always be synchronized with the full procedure, ensuring consistency and accuracy.
d) Incorporating External Information In some cases, relevant information from product
instructions for use can be included in laboratory procedures by reference. This practice
streamlines the documentation process and ensures that essential information is not
overlooked.
e) Validated Changes When the laboratory intends to make a change to an examination
procedure that has been validated, and this change may impact result interpretation, it is crucial
to communicate these implications to all relevant users. This transparency ensures that
everyone is aware of potential shifts in the interpretation of results.
f) Document Control All documents associated with the performance of examinations are
rigorously managed under the document control system. This oversight helps maintain the
accuracy, consistency, and integrity of all examination-related records and documents.

7.3.7 Ensuring the Validity of Examination Results

7.3.7.1 General
The laboratory maintains a robust procedure for actively monitoring the validity of results
obtained from examinations. This procedure ensures that all data is documented in a manner
that facilitates the detection of trends and shifts. Whenever possible, statistical techniques are
employed to rigorously analyze the results. This monitoring process is a planned and regularly
reviewed aspect of our quality management system.

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7.3.7.2 Internal Quality Control (IQC)
a) Internal Quality Control Procedure
The laboratory has established an Internal Quality Control (IQC) procedure to monitor the ongoing validity
of examination results, ensuring compliance with specified criteria. This procedure verifies the attainment
of the intended quality and maintains consistent validity relevant to clinical decision making.
1) Consideration of Clinical Application
In developing the IQC procedure, we carefully consider the intended clinical application of the examination.
We recognize that the performance specifications for the same measurand can vary in different clinical
settings.
2) Detection of Variation
Our IQC procedure is designed to detect variations, such as lot-to-lot reagent or calibrator variations, or
both, within the examination method. To facilitate this, we ensure that the laboratory procedure avoids
changing lots of IQC material on the same day/run as any lot-to-lot reagent or calibrator change.
3) Use of Third-Party IQC Material
We use IQC material as an alternative to, or in addition to, control material supplied by the reagent or
instrument manufacturer.
Monitoring of Interpretations and Opinions
Regular peer reviews of examination results are conducted to monitor interpretations and opinions.

b) Selection of IQC Material

Selection of Appropriate IQC Material
In our laboratory, we meticulously select IQC material that is suitable for its intended purpose, taking into
account various critical factors:
1) Stability Concerns
We ensure that the selected IQC material exhibits stability concerning the properties of interest.
This stability is crucial to maintain the reliability of the examination results.
2) Matching Matrix
Our selection process emphasizes choosing IQC material with a matrix as close as possible to that
of patient samples. This alignment aids in achieving consistent and accurate results.
3) Mimicking Patient Samples
The IQC material we choose reacts to the examination method in a manner that closely mimics
patient samples. This similarity ensures that the IQC material provides a reliable challenge to the
examination method.

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4) Clinical Relevance
To maintain clinical relevance, we ensure that the IQC material includes concentration levels near
or at clinical decision limits. Whenever possible, we cover the measurement range of the
examination method, enhancing the accuracy and applicability of our IQC procedures.

c) Alternative IQC Methods

Exploring Alternative IQC Methods
In our commitment to ensuring the ongoing validity of examination results, we acknowledge that there
may be instances where appropriate IQC material is unavailable. In such cases, we consider alternative
methods for IQC that align with industry best practices. These alternative methods include:
1) Trend Analysis
We perform trend analysis of patient results, which involves assessing parameters such as
moving averages of patient results, or the percentage of samples with results falling below or
above certain values or associated with specific diagnoses.
2) Comparison with Alternative Procedures
We compare results from patient samples analyzed in our laboratory to results from patient
samples examined by an alternative procedure. This alternative procedure is validated to have
its calibration metrologically traceable to the same or higher order references, as specified in ISO
17511.
3) Retesting of Retained Samples
When necessary, we employ the practice of retesting retained patient samples to ensure the
ongoing validity of examination results. These alternative IQC methods serve as vital tools in our
commitment to maintaining the accuracy, consistency, and reliability of our examination
procedures.

d) Frequency of IQC
Frequency Aligned with Examination Method
Our IQC procedure is conducted at a frequency determined by the stability and robustness of the
examination method and the potential risk of harm to the patient resulting from any erroneous results.
This approach ensures that our IQC activities are tailored to the unique characteristics and requirements
of each examination method.
e) Record and Analyze IQC Data
Detailed Data Recording and Analysis
IQC data is recorded meticulously to allow for the detection of trends and shifts. We also employ
statistical techniques, where applicable, to thoroughly review the results, enhancing our ability to
monitor and maintain the quality of our examination procedures.

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f) Regular IQC Data Review

IQC data undergoes regular reviews against specified acceptability criteria. These reviews occur at
intervals that provide a meaningful indication of the current performance of our laboratory.

g) Preventing Release of Erroneous Results

1. Immediate Action on IQC Failure: In the event that our IQC fails to meet the defined
acceptability criteria and indicates the potential for clinically significant errors in results,
we take immediate action. Results that fall within this category are rejected, and we
initiate the process of re-examining the relevant patient samples after addressing the
identified error (refer to 7.5).
2. Evaluation of Patient Samples: Results obtained from patient samples examined after
the last successful IQC event are critically evaluated to ensure that they meet the
required standards of accuracy and reliability.

Through these measures, we maintain a high level of confidence in the validity of our
examination results, consistently prioritizing patient safety and the quality of our services.

7.3.7.3 External Quality Assessment (EQA)

a) Monitoring Performance Through Comparison
Performance Monitoring
Our laboratory places significant emphasis on monitoring the performance of our examination
methods. To achieve this, we regularly compare our results with those obtained by other laboratories.
This essential process extends to our participation in EQA programs specifically tailored to the
examinations we conduct, encompassing even POCT examination methods.
b) Establishing EQA Procedures
Structured EQA Procedure
We have meticulously established a comprehensive procedure that covers EQA enrollment,
participation, and performance. This procedure is tailored to the unique examination methods we
employ, aligning with the available EQA programs to ensure the highest quality of examination results.
c) Expert Handling of EQA Samples
Proficient Personnel for EQA Samples
Our EQA samples are meticulously processed by our skilled personnel. These individuals are well-
versed in performing pre-examination, examination, and post-examination procedures. This approach
ensures that the EQA process mirrors our routine operations, guaranteeing the accuracy and reliability
of the results obtained.

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Through our commitment to EQA, we continually validate and enhance the quality of our examination
methods, ultimately benefiting the patients we serve.
d) EQA Program Selection Objectives: When selecting EQA program(s), the laboratory's objectives
encompass several key considerations:
1. Validation of Processes: The chosen EQA program(s) play a pivotal role in validating
the laboratory's pre-examination, examination, and post-examination processes.
2. Clinical Relevance: These programs are designed to supply samples that closely
resemble patient samples, presenting clinically relevant challenges to the laboratory's
testing procedures.
3. ISO/IEC 17043 Compliance: The selected EQA program(s) align with ISO/IEC 17043
requirements, ensuring that they adhere to internationally recognized standards for
proficiency testing.

e) Consideration of Target Values

Thoughtful Target Value Selection
When selecting EQA programme(s), we place thoughtful consideration on the type of target value
offered. These target values can take several forms:
1. Independently Set by a Reference Method: Where possible, we prefer target values
that are independently established by a reference method.
2. Set by Overall Consensus Data: We also value target values that are established
through overall consensus data.
3. Set by Method Peer Group Consensus Data: In certain instances, target values set
through method peer group consensus data are utilized.
4. Set by a Panel of Experts: Lastly, we consider target values established by a panel of
experts.
Our approach to target value selection ensures that we have a comprehensive understanding of
deviations, whether they are specific to our laboratory or method-independent. We
acknowledge that commutability of EQA materials can sometimes hinder comparisons between
methods. However, where commutability is feasible, we embrace the opportunity to make
inter-method comparisons, strengthening our commitment to excellence.
f) Alternative Methodologies for Monitoring
Innovative Monitoring Approaches
In situations where an EQA programme is either unavailable or not deemed suitable for a
specific examination method, our laboratory proactively employs alternative methodologies to
maintain a vigilant watch on examination method performance. We recognize that each

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alternative methodology must be thoroughly justified, backed by sound rationale, and
substantiated with concrete evidence of its efficacy.

Acceptable Alternatives
Our accepted alternatives for monitoring examination method performance include:
 Participation in Sample Exchanges: Collaborative sample exchanges with other
accredited laboratories help us evaluate and validate our examination methods.
 Interlaboratory Comparisons: By comparing our IQC results against pooled results
from participants employing the same IQC material, we gain valuable insights into the
performance of our examination methods.
 Analysis of Different Lot Numbers: We often analyze different lot numbers of the
manufacturer's end-user calibrator or trueness control material to ensure consistency in
our results.
 Analysis of Commutable Reference Materials: In instances where reference materials
align with patient samples, we employ them for evaluation purposes.
 Clinical Correlation Studies: Clinical correlation studies enable us to establish
connections between clinical outcomes and our examination results, further enhancing
the reliability of our methods.
 Utilizing Materials from Repositories: We leverage materials from cell and tissue
repositories when necessary, ensuring that our examinations are consistently validated.
Our dedication to excellence extends beyond conventional approaches, and we are committed
to using innovative methodologies that strengthen our quality assurance processes.
g) Regular EQA Data Review
Continuous Monitoring for Optimal Performance
As an integral part of our commitment to quality assurance, we conduct regular reviews of EQA
data at predefined intervals. This practice allows us to gauge our current performance
effectively. We meticulously monitor results and compare them against established
acceptability criteria.
h) Responding to Non-Conformance
In cases where EQA results deviate from the specified acceptability criteria, our dedicated team
takes appropriate action, as outlined in section 8.7 of our quality management system. One
crucial aspect of this response is a meticulous assessment to determine whether the non-
conformance holds clinical significance concerning patient samples.
i) Ensuring Patient Safety
When clinical significance is identified, we initiate a comprehensive review of patient results
that may have been affected. This rigorous assessment allows us to gauge the extent of any
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potential impact and consider necessary amendments. Subsequently, we take the appropriate
measures to inform and advise users as required. Our vigilant approach to addressing non-
conformance ensures the utmost patient safety and the reliability of our examination methods
7.3.7.4 Comparability of Examination Results - Part 5
a) Establishing Comparability
Ensuring Consistency Across Methods and Sites
Our laboratory follows a precise procedure to establish the comparability of results for patient
samples, especially when different methods, equipment, or testing locations are involved. This
procedure spans clinically significant intervals, guaranteeing the reliability and consistency of
results. We prioritize the use of patient samples for this comparison, as it circumvents issues
related to the limited commutability of IQC materials. In cases where patient samples are either
unavailable or impractical, we consider the alternative options outlined in our IQC and EQA
procedures.
b) Recorded Comparability Results
Documenting Every Step
As a commitment to transparency and accountability, our laboratory maintains a detailed
record of the results obtained during the comparability assessments. These records include
both the findings and their acceptability.
c) Ongoing Review of Comparability
Ensuring Continual Alignment
We recognize the dynamic nature of medical practices and technologies. To stay aligned with
current standards and maintain comparability, our laboratory conducts periodic reviews of our
comparability processes.
d) Evaluating Impact on Biological Reference Intervals and Clinical Decision Limits
Prioritizing Patient Well-being
When differences are identified in comparability, our laboratory conducts a comprehensive
evaluation of their impact on biological reference intervals and clinical decision limits. This
assessment allows us to take proactive measures to safeguard patient well-being and ensure
the accuracy of our results.
e) User Notification
Transparency and Communication
Our laboratory is committed to transparency. In the event of clinically significant differences in
comparability of results, we promptly notify our users. Open and clear communication is
paramount in our dedication to providing the highest standard of care.

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ASSOCAITED PROCEDURE:
Quality Management System Procedure for Verification of Examination Methods
(WMHL/QMSP/10)
Quality Management System Procedure for Quality Control (WMHL/QMSP/11)

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7.4 Post-Examination Processes
7.4.1 Result reporting
7.4.1.1 General
a) Accurate and Comprehensive Reporting
Precision in Reporting
In our medical laboratory, we place a strong emphasis on precision and clarity when reporting
examination results. Every report we generate adheres strictly to the highest standards of accuracy,
ensuring that the information is clear, unambiguous, and aligned with the specific instructions outlined in
the examination procedure. Moreover, our reports comprehensively encompass all available data
essential for the accurate interpretation of results.

b) Timely Notification for Delayed Results

Timely Communication
Our laboratory is committed to the timely delivery of results. We have established a robust procedure to
promptly notify users in cases where examination results experience delays. The decision to initiate
notifications is contingent upon evaluating the potential impact of such delays on patient care.
c) Rigorous Record Retention
Meticulous Record-Keeping
Our laboratory maintains rigorous record-keeping practices. All information associated with issued
reports is meticulously retained in strict compliance with our management system requirements. These
practices are aligned with the guidelines stipulated in Section 8.4 of our quality management system,
ensuring comprehensive information retention.
We want to emphasize that our dedication to the highest standards of result reporting applies universally.
Whether reports are issued in hard copy format or electronically, we remain unwavering in our
commitment to meet the stringent requirements outlined in this document.

7.4.1.2 Result Review and Release

Comprehensive Review
Thorough Examination Result Evaluation
In our medical laboratory, we maintain a stringent protocol for the review and authorization of
examination results before their release. This step is pivotal to ensuring the quality and accuracy of our
reporting.
In-depth Assessment
Comprehensive Assessment Process
Our laboratory places a strong emphasis on the in-depth evaluation of results. Authorized personnel, as
designated in our protocols, meticulously review the examination results. During this process, they
critically assess the results against the backdrop of our internal quality control (IQC) measures.
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Additionally, our team considers any pertinent clinical information and previous examination results that
may be available, ensuring a holistic and thorough assessment.

Defined Responsibilities and Procedures

Clear Release Protocols
We have established clearly defined responsibilities and procedures for the release of
examination results. Our protocols specify who is authorized to release results and to whom
they are released. These meticulous procedures serve to maintain the integrity and
confidentiality of our reporting process.

7.4.1.3 Critical Result Reports

a) Immediate Notification
Swift Critical Result Communication
In our medical laboratory, when examination results fall within established critical decision limits, we
prioritize immediate action. The user or another authorized person is promptly notified. This
notification is based on the clinical information available to ensure swift and appropriate response.
b) Detailed Documentation
Thorough Documentation of Actions
Our laboratory maintains rigorous documentation practices. In the event of critical result reporting, we
meticulously document various aspects of the process, including the date and time of the notification,
the responsible person, the recipient of the notification, the results conveyed, verification of the
accuracy of communication, and any difficulties encountered during the notification process.
c) Escalation Procedure
Effective Escalation Protocol
To handle situations where a responsible person cannot be contacted, our laboratory has established an
escalation procedure for laboratory personnel. This ensures that even in challenging scenarios, critical
results are addressed promptly and efficiently.

7.4.1.4 Special Considerations for Results

a) Simplified Reporting with User Agreement
Customized Reporting with User Agreement
In our medical laboratory, we understand that there may be instances where users prefer simplified
reporting of results. We accommodate this based on user agreements. However, any information not
reported to the user, as outlined in sections 7.4.1.6 and 7.4.1.7, is readily available upon request.

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b) Transmission of Preliminary Reports
Preliminary Reports and Final Reports
When results are transmitted as preliminary reports, our laboratory ensures that the final report is
always forwarded to the user. This practice guarantees that users receive comprehensive and conclusive
information.
c) Documentation of Oral Results
Detailed Documentation of Oral Results
For results provided orally, our laboratory maintains meticulous records. This includes recording details
Of the verification of accuracy of communication, as specified in 7.4.1.3b. Additionally, oral results are
always followed by a formal written report.
d) Special Counselling for Critical Results
Ensuring Adequate Counselling for Critical Results
In cases where examination results carry serious implications for the patient, such as genetic or specific
infectious diseases, special counselling may be necessary. Our laboratory management takes
responsibility for ensuring that such results are not communicated to the patient without providing
them with the opportunity for adequate counselling and support.
e) Responsible Use of Anonymized Results
Ethical Use of Anonymized Results
We recognize the value of anonymized results for purposes like epidemiology, demography, or statistical
analyses. However, our laboratory strictly adheres to ethical practices and regulatory requirements to
mitigate all risks related to patient privacy and confidentiality. This ensures responsible and lawful
utilization of anonymized data.

7.4.1.5 Automated Selection, Review, Release, and Reporting of Results

a) Criteria for Automated Handling
Defining Automated Handling Criteria
In our medical laboratory, we have established clear criteria for the automated selection,
review, release, and reporting of results. These criteria are specified, approved, readily
available, and well-understood by personnel responsible for authorizing result releases.
b) Validation and Regular Review
Ensuring Valid and Consistent Criteria
Prior to implementation, all criteria related to automated handling undergo a thorough
validation process. Once in use, these criteria are subject to regular review and verification. Any
changes to the reporting system that may affect the functioning of these criteria, potentially
jeopardizing patient care, are carefully examined and approved.

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c) Identifiable Results for Manual Review
Identifying Results for Manual Review
Results selected for manual review by our automated reporting system are easily identifiable.
Additionally, we record the date and time of selection and review, along with the identity of the
reviewer, when appropriate. This meticulous documentation ensures traceability and
accountability.
d) Rapid Suspension Protocols
Rapid Response for System Suspension
Our laboratory has established protocols for the rapid suspension of automated selection,
review, release, and reporting when necessary. This measure helps to maintain the integrity of
the reporting process and ensures patient safety.
7.4.1.6 Requirements for Reports
a) Patient Identification and Sample Dates
Ensuring Comprehensive Patient and Sample Information
In our medical laboratory, each report is meticulously crafted to include the following
information:
 Unique Patient Identification: The report prominently displays a unique patient
identifier.
 Date of Primary Sample Collection: The date when the primary sample was collected is
indicated on each page of the report.
 Date of Report Issuance: Similarly, the date of the report's issuance is displayed for
clarity and reference.

b) Laboratory Identification
Identifying the Source of the Report
Our reports include a clear identification of the laboratory issuing the report. This ensures
transparency and traceability.
c) User Identification
Catering to Individual Users
The name or other unique identifier of the user receiving the report is included, tailoring each
report to its intended recipient.
d) Sample Information
Describing Samples Precisely
To provide comprehensive context, our reports detail the type of primary sample and include
any specific information necessary to describe the sample. This may encompass details such as
the source and site of the specimen, along with a macroscopic description when relevant.
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e) Examination Details
Clarifying Examination Details
Examinations performed are presented in a clear and unambiguous manner, ensuring the user
easily understands the scope of the report.
f) Examination Method
Method Identification
Where relevant, our reports identify the examination method employed. To enhance clarity, we
also include harmonized (electronic) identification of the measurand and measurement
principle whenever possible and necessary. Examples of such electronic identification include
Logical Observation Identifiers Names and Codes (LOINC) and Nomenclature for Properties and
Units (NPU, NGC), as well as SNOMED CT.
g) Clear Reporting of Results
Reporting Results with Precision
Our reports present examination results, along with appropriate units of measurement. These
units are reported in SI units, units traceable to SI units, or other applicable units. This precision
ensures the clarity and accuracy of result communication.
h) Inclusion of Reference Intervals and Clinical Decision Limits
Supporting Informed Clinical Decisions
Our reports include essential information such as biological reference intervals, clinical decision
limits, and, when necessary, likelihood ratios. To aid in the interpretation of results, we may also
provide diagrams or nomograms. Additionally, lists or tables of biological reference intervals are
made available to laboratory users.
i) Identification of Research or Development Examinations
Transparency in Research and Development
Examinations conducted as part of a research or development program, for which specific claims
on measurement performance may not be available, are clearly identified in our reports.
j) Transparent Authorship
Transparency in Reporting Oversight
We ensure transparency by identifying the person(s) responsible for reviewing the results and
authorizing the release of the report. This information is readily available when needed, either
within the report or through our records.
k) Identification of Preliminary Results
Distinguishing Preliminary Findings
When results are preliminary in nature, our reports include clear indications to prevent
any misinterpretation.

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l) Highlighting Critical Results
Urgent Attention to Critical Findings
Critical results are distinctly marked within our reports, ensuring immediate attention and
appropriate action.
m) Effective Page Identification
Clear Page Structure
Our reports include unique identifications for all components, signifying their role as part of a
complete report. Furthermore, we provide clear end-of-report markers, such as page numbers in
the format "page number to total number of pages."

7.4.1.7 Additional Information for Reports

a) Inclusion of Sample Collection Time
Timing Matters for Patient Care
When necessary for effective patient care, our reports include the time of primary sample
collection. This timing detail ensures that healthcare providers have a complete understanding
of the patient's condition.
b) Transparency in Report Release Time
Access to Report Release Time
If the time of report release is not included within the report itself, it is made readily available
when needed. This transparency aids in tracking and managing patient care timelines.

c) Collaborative Reporting with Referral Laboratories

Collaborative Reporting from Referral Laboratories
Reports of results originating from examinations or components of examinations performed by
referral laboratories include any information provided by consultants. Additionally, the name of
the laboratory responsible for conducting these examinations is prominently mentioned.
d) Comprehensive Interpretation and Comments
Enhancing Result Interpretation
Our reports go beyond result presentation; they provide valuable interpretation and comments.
This includes insights on:
1. Sample Quality and Suitability: We address any concerns related to sample quality and
suitability that might compromise the clinical value of examination results.
2. Handling Discrepancies: When examinations are conducted using different procedures,
such as Point-of-Care Testing (POCT), or in various locations, we highlight any
discrepancies that may affect result interpretation.
3. Units of Measurement: To prevent misinterpretation, we alert users to potential risks
associated with different units of measurement in use regionally or nationally.
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4. Monitoring Result Trends: Our reports emphasize result trends and significant changes
over time. This longitudinal perspective aids in tracking a patient's health status.
These comprehensive insights empower healthcare providers to make informed decisions and
ensure the best possible care for patients.

7.4.1.8 Amendments to Reported Results

a) Recording Reason for Changes
Transparency in Result Amendments
Our procedures for issuing amended or revised results ensure complete transparency. When a
change is made, the reason behind the modification is recorded and included in the revised
report, whenever relevant. This practice helps users understand the basis for any alterations.
b) Clearly Identifiable Revised Results
Distinct Identification of Revised Results
Revised results are conveyed exclusively as an additional document or data transfer. They are
unequivocally identified as revised, with clear indications of the date and the patient's identity
as initially reported. This transparency assures users that any modifications have been
accurately noted.
c) User Awareness of Revisions
User-Centric Approach to Result Amendments
User awareness is a priority. When a revision occurs, we ensure that the respective user is
promptly informed about the change. This proactive communication fosters trust and aids in
clinical decision-making.
d) Traceable New Reports
Traceability in Replacement Reports
In instances where it becomes necessary to issue an entirely new report, it is uniquely identified.
This new report contains references and traceability links to the original report that it replaces.
This approach ensures the seamless flow of information while preserving data integrity.
e) Keeping Records of Untracked Revisions
Documenting Untracked Revisions
In cases where our reporting system cannot automatically capture revisions, we maintain a
record of these untracked modifications. This record-keeping practice ensures that even minor
revisions are documented and available for reference when needed.
Through these practices, we maintain the highest standards of accuracy and transparency in
reporting results, reinforcing our commitment to quality healthcare.

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7.4.2 Post-Examination Handling of Samples
Ensuring Sample Integrity and Accessibility
Our laboratory recognizes the critical importance of proper post-examination handling of
samples. We have established robust procedures to ensure the integrity and accessibility of
samples.
a) Maintaining Patient and Source Identification
Preserving Sample Identity
Patient and source identification of the sample are diligently maintained. This practice ensures
that the origin of each sample is clearly documented and preserved throughout its storage
duration.
b) Verifying Sample Suitability
Confirming Sample Viability
We make it our responsibility to confirm the suitability of each sample for potential additional
examination. This proactive approach minimizes the risk of using unsuitable samples in future
testing.
c) Optimal Sample Preservation
Optimal Storage Conditions
Samples are stored under conditions that optimally preserve their suitability for any potential
additional examination. Our storage facilities and protocols are designed to maintain the quality
and integrity of the samples.
d) Locating and Retrieving Samples
Efficient Sample Tracking
Efficient sample tracking is a priority. We ensure that each sample can be easily located and
retrieved when needed. This systematic approach minimizes delays and enhances the efficiency
of our laboratory operations.
e) Appropriate Sample Disposal
Responsible Sample Disposal
Once a sample has fulfilled its purpose, we ensure it is discarded appropriately. Our disposal
procedures adhere to all relevant regulations and guidelines, guaranteeing responsible and safe
disposal practices.
Through these measures, we uphold the highest standards of sample management, ensuring the
reliability and integrity of our laboratory processes.
ASSOCIATED PROCEDURE: Quality Management System Procedure for Patient communication
in case of delay of test results (WMHL/QMSP/12).
Quality Management System Procedure for Review and Release and amendment of Examination
Results (WMHL/QMSP/13).
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7.5 Nonconforming Work
Ensuring Accountability and Quality Excellence
Our laboratory is committed to maintaining the highest standards of quality. When any aspect of
our laboratory activities or examination results deviate from established procedures, quality
specifications, or user requirements, we have a meticulous process in place for managing
nonconforming work.
a) Specifying Responsibilities and Authorities
Clear Accountability
We clearly define responsibilities and authorities for the management of nonconforming work.
This ensures that accountability is established and maintained throughout the process.
b) Immediate and Long-Term Actions
Proactive Response
Our response to nonconforming work is both immediate and long-term. We base our actions on
a thorough risk analysis process, which helps us determine the appropriate steps to address the
issue effectively.
c) Ensuring Patient Safety
Patient-Centric Approach
Patient safety is paramount. In situations where there is a risk of harm to patients, we prioritize
safety above all else. We halt examinations and withhold reports to mitigate any potential harm.
d) Clinical Significance Evaluation
Assessing Clinical Impact
We conduct a comprehensive evaluation of the clinical significance of nonconforming work. This
includes an in-depth impact analysis on examination results that were either released or could
have been released before identifying the nonconformance.
e) Determining Acceptability
Rigorous Assessment
A rigorous assessment is carried out to determine the acceptability of nonconforming work. This
assessment considers the potential impact on patient care and laboratory quality.
f) Result Revision and User Notification
Transparent Communication
If necessary, we revise examination results and promptly notify the user. Transparency in
communication is a core principle of our corrective actions.

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g) Authorizing Work Resumption
Controlled Resumption
We have a well-defined process for authorizing the resumption of work. This ensures that work
only recommences when all necessary measures have been taken to address the
nonconformance.
Our laboratory is committed to implementing corrective actions that align with the risk of
recurrence of nonconforming work, as outlined in Section 8.7 of our quality management
system.
We maintain comprehensive records of nonconforming work and associated actions, adhering to
the guidelines specified in 7.5 (a) to (g).

ASSOCIATED PROCEDURE: Quality Management System Procedure for Non-conforming work

and its corrective action (WMHL/QMSP/14)

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7.6 Control of Data and Information Management
Ensuring Data Access and Management
In our commitment to delivering top-quality laboratory services, we understand the critical
importance of controlling data and managing information effectively.

7.6.1 General
Fundamental Access
Our laboratory ensures that we have access to the necessary data and information essential for
the seamless execution of laboratory activities.
Note 1: Comprehensive Information Systems
Our approach encompasses all laboratory information systems, covering both computerized and
non-computerized systems. While some requirements are more relevant to computer systems,
we acknowledge the significance of all information management aspects.
Information Security
Our information security controls, strategies, and best practices ensure the utmost protection of
sensitive data.

7.6.2 Authorities and Responsibilities for Information Management

Defined Roles for Effective Information Management
Our laboratory places paramount importance on defining clear roles and responsibilities to
manage our information systems effectively.
Specifying Authorities and Responsibilities
Clearly Defined Oversight
To ensure the seamless functioning of our information systems, we have designated authorities
and outlined specific responsibilities. This includes overseeing the maintenance and any
necessary modifications to our information systems that could impact patient care.
Ultimate Responsibility
As the laboratory, we acknowledge and accept the ultimate responsibility for the management
and governance of our laboratory information systems.

7.6.3 Information Systems Management

Ensuring Reliable Information Systems
Our laboratory maintains a robust system for the management of information systems, which is
essential for reliable examination data and information handling.
a) Validation and Verification
Rigorous Validation and Verification
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Before introducing any system used for data collection, processing, recording, reporting,
storage, or retrieval of examination data and information, we ensure it undergoes rigorous
validation and verification. This includes validating systems by the supplier and verifying
functionality by our laboratory. Any system changes, software configurations, or
modifications are authorized, documented, and validated before implementation. We also
verify proper interface functionality between our laboratory information system and other
relevant systems, such as laboratory equipment, patient administration systems, and
primary care systems.
b) Documentation and Availability
Comprehensive Documentation
All information system processes are well-documented, and this documentation is readily
accessible to authorized users. This documentation covers the day-to-day functioning of the
system.
c) Consideration of Cybersecurity
We implement information systems while considering cybersecurity measures to protect
against unauthorized access and ensure data integrity. This includes safeguarding data from
tampering or loss
d) Operational Environment
Optimal Operational Environment
Our information systems are operated within environments that adhere to supplier
specifications. In cases of non-computerized systems, we provide conditions that guarantee
accurate manual recording and transcription.
e) Maintenance and Integrity
Data Integrity Assurance
To ensure data and information integrity, we maintain our information systems diligently.
This includes recording system failures and promptly taking appropriate corrective actions.
f) 5 Data Checks
Systematic Data Verification
We perform systematic checks on calculations and data transfers to maintain data accuracy
and reliability.

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7.6.4 Downtime Plans
Maintaining Operations during Downtime
Our laboratory has established planned processes to ensure uninterrupted operations in the
event of system failure or downtime affecting our information systems, including automated
selection and reporting of results.

7.6.5 Off-Site Management

Ensuring Compliance in Off-Site Management
When our laboratory information system(s) are managed and maintained off-site or by an
external provider, we take measures to ensure that the provider or operator complies with all
applicable requirements outlined in this document.

ASSOCIATED PROCEDURE: NIL

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7.7 Complaints

7.7.1 Established Process

The laboratory operates a robust system for managing complaints, ensuring transparency and
accountability in addressing concerns raised by patients, users, or relevant parties.
Key Components: This process encompasses several key components, including:

a) Complaint Handling:
 Reception and Verification: Complaints are received and carefully verified to establish
their legitimacy and relevance.
 Investigation: A thorough investigation is initiated to delve into the nature and causes of
the complaint.
 Decision and Action: Based on the investigation, decisions are made regarding the
necessary actions. These actions can involve the implementation of corrective measures
as outlined in section 8.7 or feed into the broader improvement process as outlined in
section 8.6.

b) Tracking and Recording:

 Every complaint, along with the actions taken to address it, is diligently tracked and
recorded for future reference.

c) Ensuring Adequate Action:

 The laboratory takes prompt and appropriate action in response to the complaint,
addressing the root causes and preventing their recurrence.

Public Availability: The laboratory believes in transparency and makes the description of its
complaints handling process readily available to the public. This demonstrates the laboratory's
commitment to accountability and continuous improvement in patient care and service delivery.

7.7.2 Receipt of Complaint

a) Confirming Relevance:
 When the laboratory receives a complaint, the first step is to verify if it pertains to the
laboratory's activities and responsibilities. If it does, the laboratory proceeds to address
the complaint as per the established process outlined in section 7.7.1.

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b) Information Gathering:
 The laboratory, upon receiving a complaint, takes on the responsibility of collecting all
necessary information to make a sound determination regarding the legitimacy and
validity of the complaint.

c) Acknowledgment and Communication:

 Whenever possible, the laboratory acknowledges receipt of the complaint. This
acknowledgment includes providing the complainant with information regarding the
outcome of the complaint and, if applicable, periodic progress reports. This
communication ensures transparency and keeps the complainant informed throughout
the process.
The laboratory is committed to handling complaints promptly and professionally,
fostering trust, and demonstrating its dedication to quality and patient satisfaction.

7.7.3 Resolution of Complaint

Investigation and Resolution:
 The laboratory is committed to addressing and resolving complaints in a fair and
unbiased manner. It ensures that the investigation and resolution of complaints do not
lead to any form of discriminatory actions.
Involvement of Unbiased Parties:
 To maintain objectivity and impartiality, the resolution of complaints is carried out by
individuals who are not directly involved in the subject matter of the complaint. They
provide an unbiased perspective in assessing and resolving the issue at hand.
Resource Constraints and Impartiality:
 In cases where resource limitations may hinder the involvement of unrelated parties, an
alternative approach is adopted. However, this alternative approach is designed to ensure
that impartiality is not compromised, safeguarding the integrity of the complaint
resolution process.
The laboratory places a high value on addressing complaints with fairness and integrity,
fostering a culture of trust and accountability within its operations.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for handling of feedback and customer
complaint (WMHL/QMSP/15).

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Doc No. QUALITY MANUAL Section No.: QMS 7.8
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7.8 Continuity and emergency preparedness planning

Identifying Risks: The laboratory maintains a vigilant approach to identifying potential risks
associated with emergency situations. These risks encompass a wide range of scenarios, from
natural disasters to infrastructure failures, that might limit or disrupt laboratory activities.

Coordinated Strategy: To ensure seamless operations in the face of such disruptions, the
laboratory has developed a comprehensive strategy. This strategy is a well-coordinated effort
that incorporates detailed plans, established procedures, and technical measures.

Testing and Exercising Plans: Regular testing of these plans is a critical aspect of
preparedness. The laboratory periodically conducts tests to evaluate the effectiveness of its
response plans and the capability of its personnel to execute them. This testing is not just a
theoretical exercise; it's a practical measure to ensure readiness.

a) Planned Emergency Response: In anticipation of emergency situations, the laboratory

establishes a comprehensive response plan. This plan takes into consideration the needs and
capacities of all relevant laboratory personnel, ensuring a coordinated approach to tackle
various contingencies.

b) Information and Training: To equip laboratory personnel with the necessary skills and
knowledge, the laboratory provides essential information and training. This training is tailored
to ensure that personnel can effectively contribute to the planned emergency response.

c) Response to Actual Emergencies: When faced with actual emergency situations, the
laboratory promptly activates its response plan. This includes mobilizing resources and
personnel to address the situation effectively.

d) Mitigating Emergency Consequences: The laboratory takes appropriate actions to prevent

or minimize the consequences of emergency situations. The magnitude of the emergency and its
potential impact determine the extent of these actions, ensuring a proportionate response.

ASSOCIATED PROCEDURE: Nil

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Doc No. QUALITY MANUAL Section No.: QMS 8.1
WMHL/PATH/QM/01 ISO 15189:2022
8 Management system requirements
8.1 General requirements
8.1.1 General (Establishing a Management System)
The laboratory is required to establish, document, implement, and maintain a comprehensive management
system that ensures the consistent compliance with the standards outlined in this document. This
management system should encompass the following key elements:

8.1 - Responsibilities
8.2 - Objectives and Policies
8.2, 8.3, and 8.4 - Documented Information
8.5 - Addressing Risks and Opportunities for Improvement
8.6 - Continual Improvement
8.7 - Corrective Actions
8.8 - Evaluations and Internal Audits
8.9 - Management Reviews
These components collectively form the foundation of an effective management system in the
laboratory, providing the structure and processes needed.

8.1.2 Fulfilment of management system requirements

To meet the requirements set out in 8.1.1, the laboratory has the option to establish, implement, and
maintain a quality management system. This system, which can align with the ISO 9001 standards, plays a
crucial role in supporting and demonstrating the consistent fulfilment of the requirements detailed in
Clauses 4 to 7 and those specified in 8.2 to 8.9. By adopting such a quality management system, the
laboratory can ensure a structured approach to meeting these critical standards.

8.1.3 Management system awareness

The laboratory places a strong emphasis on ensuring that all individuals working under its control are
well-informed and aware of key aspects related to the management system. This awareness encompasses:

a) Relevant Objectives and Policies: Individuals are made aware of the laboratory's
objectives and policies that guide its operations.

b) Contributions to Effectiveness: Personnel are informed about how their work directly
contributes to enhancing the effectiveness of the management system. This includes
understanding the advantages of improved performance resulting from their
contributions.

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c) Consequences of Non-Conformance: Individuals are educated about the potential
repercussions of not adhering to the requirements of the management system. This
awareness encourages compliance and responsible conduct among laboratory
personnel.

ASSOCAITED PROCEDURE: NIL

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8.2 Management system documentation
8.2.1 General (Establishing Objectives and Policies)
In line with the requirements, laboratory management has established, documented, and
maintained clear objectives and policies. These objectives and policies are designed to serve the
overarching goals outlined in this document. Importantly, they are not merely words on paper;
they are acknowledged and actively implemented across all levels of the laboratory
organization. It's worth noting that these management system documents can be found in a
quality manual.
8.2.2 Addressing Competence and Quality
Within these objectives and policies, there is a strong emphasis on addressing key areas
essential for the laboratory's success. This includes a focus on competence, ensuring that all
personnel possess the necessary skills and expertise, as well as a commitment to maintaining
high levels of quality and consistent operation throughout the laboratory.
8.2.3 Evidence of Commitment
Laboratory management doesn't just stop at documentation; they provide tangible evidence of
their commitment to the development and implementation of the management system. This
commitment extends to a continual effort to enhance the system's effectiveness, reflecting the
laboratory's dedication to ongoing improvement and excellence.
8.2.4 - Comprehensive Documentation
As per these requirements, the laboratory leaves no stone unturned when it comes to
documentation. Every aspect, whether it be documentation, processes, systems, or records,
related to meeting the requirements outlined in this document, is thoughtfully included in,
referenced from, or linked to the management system. This meticulous approach ensures that
every detail is accounted for and that nothing falls through the cracks.
8.2.5 – Personnel Access
Recognizing the importance of accessibility, the laboratory extends access to its management
system documentation and related information to all personnel involved in laboratory
activities. This inclusive approach ensures that everyone who plays a role in the laboratory's
operations has access to the parts of the management system documentation that are relevant
to their specific responsibilities. This accessibility promotes transparency, accountability, and
effective collaboration among all members of the laboratory team.

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.: QMS 8.3
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8.3 Control of management system documents
8.3.1 General (Document Control)
This section underscores the importance of meticulous document control within the laboratory's
management system. The laboratory is responsible for maintaining control over all documents,
whether they are internal or external, that pertain to the requirements set out in this document.
The definition of "document" in this context is comprehensive, encompassing a wide array of
materials, from policy statements to manufacturer's instructions, both in physical and digital
formats. This rigorous approach ensures that every piece of information and instruction that
influences the laboratory's operations is well-regulated and properly managed.

Scope of Document Control: All documents those may vary based on changes in
version and/or time which include as follows:
 Quality Manual and other policy statement.
 Quality Management System Procedures (QMSP).
 Standard Operating Procedure/Work Instruction and other form of instruction.
 Flow Chart/Process Maps.
 Forms’ Formats and Registers.
 Calibration tables and calibration certificates.
 Biological Reference intervals and their origin.
 Documents in Electronic Format.
 Text Book.
 Any other reference document.
 Normative Reference.
 Quality Management System Standards (ISO 15189:2022) and
 Documents of Regulation and Accreditation Authority.
 Charts, Posters, Notices, Memoranda.
 Software Document.
 Drawings, Plans, Agreements.

8.3.2 Control of documents

In this section, we outline how the laboratory ensures stringent control over its documents
in practice. Here, we provide a detailed look at how the laboratory practices robust
document control:

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8.3.2a - Unique Identification: Each document is assigned a distinct identifier, such as a code or
reference number. This practice eliminates any ambiguity and ensures that each document can
be easily traced and referenced.

8.3.2b - Expert Approval: Prior to release, authorized personnel with the requisite expertise
and competence meticulously review and approve documents. Their expertise guarantees that
documents meet the necessary standards and criteria.

8.3.2c - Regular Updates: Documents undergo periodic reviews to ensure ongoing relevance
and alignment with the latest industry developments. Updates are promptly implemented when
changes in procedures, standards, or other relevant factors arise.

8.3.2d - Accessible Versions: To ensure the use of the correct document version, the laboratory
maintains a centralized document repository. Here, the latest document versions are stored and
readily accessible to all personnel who require them.

8.3.2e - Clearly Marked Changes: Whenever a document is updated, all modifications are
clearly and transparently marked. This practice enables users to easily identify alterations made
between document versions.

8.3.2f - Preventing Unauthorized Changes: Stringent security measures are in place to

safeguard documents from unauthorized alterations. Access to sensitive documents is restricted
to authorized personnel, and a comprehensive audit trail is maintained to track any changes
made.

8.3.2g - Controlled Access: Access to documents is systematically controlled using a role-based

access control system. This ensures that only individuals with the appropriate authorization can
view, modify, or approve documents.

8.3.2h - Managing Obsolete Documents: Documents that become obsolete due to updates or
changes in procedures are clearly labeled as such. This unambiguous designation helps prevent
the accidental use of outdated information.

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8.3.2i - Retention of Obsolete Documents: Even after a document is marked as obsolete, the
laboratory retains at least one paper or electronic copy for a specified period. This retention
serves as a historical record for reference and auditing purposes, allowing the laboratory to
track its evolution and adhere to regulatory requirements.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Document Control (WMHL/QMSP/16)

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8.4 Control of records (Record Management):
8.4.1 Records to Demonstrate Compliance:
The laboratory diligently establishes and retains legible records as concrete evidence of how it
adheres to the requirements specified in this document. These records serve as a transparent
account of the laboratory's activities and practices.

Timely Record Creation: Whenever an activity that influences the quality of an examination is
carried out, the laboratory promptly generates the necessary records. This ensures that records
accurately reflect the chronological sequence of events and actions.

Medium Versatility: The format or medium of records may vary; they can exist in physical or
digital forms, depending on the nature of the activity. The laboratory remains flexible in this regard.

8.4.2 Amendment of records

Traceable Amendments: The laboratory takes meticulous care to ensure that any changes made to
records are traceable. This traceability is achieved by referencing either previous versions or the
original observations.
Preserving Historical Data: Both the original and amended data and files are securely preserved.
These records include essential details such as the date and, when relevant, the time of alteration.
Additionally, the records indicate precisely which aspects were altered and the identity of the
personnel responsible for making these changes.
By adhering to these practices, the laboratory maintains a robust record management system,
ensuring the integrity and reliability of its documented information

8.4.3 Retention of records

Here we delve into how the laboratory manages the retention of records, ensuring their
accessibility and security:

a) Comprehensive Record Management Procedures

The laboratory takes a systematic approach to record management, implementing procedures that
cover various aspects, including:
 Identification: Each record is clearly marked and identified, ensuring it can be easily
located and distinguished.
 Storage: Records are stored in a secure and controlled environment to protect them from
damage or loss.

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 Protection from Unauthorized Access and Changes: Stringent measures are in place to
prevent unauthorized access to records. Any changes to records are meticulously
controlled and monitored.
 Backup and Archive: Procedures for creating backups and archiving records are
established to safeguard against data loss.
 Retrieval: Records must be readily retrievable when needed, ensuring that historical
data is accessible.
 Retention Time: Clear guidelines for the retention time of records are specified.

b) Specified Retention Times

The laboratory determines the retention times for records, taking into consideration both
regulatory requirements and identified risks. The chosen retention times may vary depending
on the nature of the records and associated risks.

c) Accessibility of Examination Results

Reported examination results are kept accessible for as long as necessary or as required. This
ensures that past examination results can be retrieved whenever needed, even beyond their
immediate use.

d) Legibility and Availability

Throughout the entire retention period, records are maintained in a legible format, regardless of
the medium in which they are stored. Furthermore, all records remain available for periodic
reviews by laboratory management, as outlined in section 8.9.
It's important to note that certain types of procedures, such as histology examinations, genetic
examinations, or pediatric examinations, may carry legal liabilities that necessitate longer
retention times for specific records. The laboratory carefully considers these requirements in its
record retention strategy.

ASSOCIATED PROCEDURE:
Quality Management System Procedure for Records (WMHL/QMSP/14)

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Doc No. QUALITY MANUAL Section No.: QMS 8.5
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8.5 Actions to address risks and opportunities for improvement
In this section, we delve into how the laboratory identifies and responds to risks while proactively
seeking opportunities for improvement in its operations:

8.5.1 Identification of risks and opportunities for improvement

a) Preventing or Reducing Undesired Impacts: The laboratory conducts a comprehensive
assessment to identify potential risks that could result in undesired impacts or failures in its
activities. The primary aim is to prevent or minimize these occurrences, thereby ensuring the
seamless operation of laboratory activities.

b) Achieving Improvement: Opportunities for improvement are actively sought out and acted
upon. This involves a constant endeavor to enhance processes, methods, or systems within the
laboratory. By seizing these opportunities, the laboratory can evolve and deliver even better
outcomes.

c) Assuring Intended Results: The laboratory evaluates its management system to ensure that it
consistently achieves the intended results. This involves a systematic review of processes and
practices to maintain high standards.

d) Mitigating Risks to Patient Care: Risks that could potentially impact patient care are
identified and meticulously assessed. Measures are then implemented to mitigate these risks,
safeguarding the safety and well-being of patients.

e) Fulfilling Laboratory's Purpose and Objectives: Risks and opportunities are assessed in
alignment with the laboratory's overarching purpose and objectives. This ensures that risk
management and improvement efforts are closely tied to the laboratory's mission.

8.5.2 Acting on risks and opportunities for improvement

Prioritizing Risks and Opportunities: The laboratory prioritizes the identified risks and
opportunities for improvement, giving precedence to those with the greatest potential impact on
laboratory examination results, patient safety, and the well-being of personnel.

Recording Decisions and Actions: Every decision made and action taken in response to risks
and opportunities is thoroughly documented. This meticulous record-keeping creates a
comprehensive history of the laboratory's risk management and continuous improvement
efforts.

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Integrating Actions: Actions aimed at addressing risks and harnessing improvement
opportunities are seamlessly integrated into the laboratory's management system. This ensures
that these actions become an integral part of the laboratory's daily operations.

Evaluating Effectiveness: The laboratory actively evaluates the effectiveness of the actions
taken in response to identified risks and opportunities. This ongoing evaluation process serves
as a feedback loop, helping the laboratory refine and optimize its risk management strategies
and improvement initiatives.
Through this systematic approach to addressing risks and embracing opportunities for
improvement, the laboratory not only ensures the highest standards of quality and safety but
also maintains its commitment to delivering excellence in patient care.

ASSOCIATED PROCEDURE: Nil

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Doc No. QUALITY MANUAL Section No.: QMS 8.6
WMHL/PATH/QM/01 ISO 15189:2022
8.6 Improvement
In this section, we delve into how the laboratory actively strives for continual improvement
across its management system:

8.6.1 Continual improvement

a) Ongoing Enhancement: The laboratory is dedicated to the continuous enhancement of its
management system, encompassing all stages from pre-examination through examination to
post-examination processes. This commitment is embedded in the laboratory's objectives and
policies.

b) Identifying Opportunities for Enhancement: The laboratory proactively identifies and

selects opportunities for improvement. It meticulously documents these opportunities and,
where necessary, formulates and executes actions to realize these improvements. The
prioritization of improvement efforts is based on comprehensive risk assessments and the
opportunities pinpointed (as detailed in 8.5).
Opportunities for improvement may arise from various sources, including risk assessments,
policy utilization, scrutiny of operational procedures, alignment with overall objectives,
examination of external evaluation reports, internal audit findings, resolution of complaints,
corrective actions, management reviews, suggestions from staff, as well as feedback from
patients and users. Additionally, the analysis of data and results from external quality
assessment (EQA) programs contribute to the identification of areas ripe for improvement.

c) Evaluating Effectiveness: Following the implementation of improvement actions, the

laboratory meticulously evaluates their effectiveness. This evaluation process ensures that
improvements are not only initiated but also successfully contribute to the laboratory's overall
performance.

d) Participation in Wider Improvement Initiatives: Laboratory management ensures that the

laboratory actively participates in continual improvement activities that encompass relevant
areas and outcomes of patient care. This commitment extends beyond the laboratory's
immediate operations and encompasses broader initiatives to elevate the quality of patient
care.

e) Transparency in Improvement Plans: Laboratory management maintains open lines of

communication with personnel regarding its improvement plans and associated goals. This
transparency fosters a collective commitment to driving positive change and encourages staff to
actively contribute to the laboratory's ongoing improvement journey.

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Through these concerted efforts, the laboratory ensures that it remains at the forefront of
excellence in its services, continuously enhancing its capabilities to provide the highest
standards of patient care and quality in all aspects of its operations.

8.6.2 Laboratory patients, user, and personnel feedback

In this section, we explore how our laboratory actively engages with its patients, users, and
personnel to gather valuable feedback and utilize it to enhance its management system and
services:
Seeking Varied Perspectives
 Feedback Collection: The laboratory proactively solicits feedback from three key
stakeholder groups: patients, users, and personnel. This inclusive approach ensures that
a wide array of perspectives, encompassing those who receive services, those who utilize
them, and those who provide them, are considered.
Analyzing and Acting Upon Feedback
 Feedback Analysis: Upon collection, the gathered feedback is subjected to a thorough
analysis. This analysis delves into the insights provided by patients, users, and personnel,
identifying areas for improvement within the laboratory's management system, activities,
and the services rendered to users.
 Driving Improvement: The insights gleaned from this feedback analysis serve as a
catalyst for driving improvements within the laboratory. Whether it pertains to
enhancing management processes, refining laboratory activities, or optimizing user
services, actionable steps are taken to address the identified areas of improvement.
Documentation and Accountability
 Maintaining Records: To ensure transparency and accountability, records of all received
feedback, along with the corresponding actions taken, are meticulously maintained. This
documentation provides a historical record of the laboratory's responsiveness to
feedback and its commitment to improvement.
 Communicating Actions: The laboratory maintains open lines of communication with its
personnel by providing clear and timely information regarding the actions taken as a
result of their feedback. This feedback loop fosters a sense of involvement and
accountability among laboratory staff.
Through this comprehensive approach to feedback solicitation, analysis, and action, the
laboratory continually refines its operations and services, aligning them more closely with the
needs and expectations of its patients and users. This dedication to improvement ensures that
the laboratory remains agile and responsive in a dynamic healthcare landscape.
ASSOCIATED PROCEDURE: Nil

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Doc No. QUALITY MANUAL Section No.: QMS 8.7
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8.7 Nonconformities and corrective actions
8.7.1 Actions when nonconformity occurs
8.7.1.a Immediate Reaction to Nonconformity:
a) Swift Response: When a nonconformity occurs, the laboratory promptly reacts. This
reaction encompasses taking immediate steps to control and rectify the nonconformity.
This swift action ensures that the situation is contained and corrected without delay.

b) Focusing on Patient Safety: While addressing nonconformities, there's a particular

emphasis on patient safety. Any potential consequences stemming from the
nonconformity are evaluated and managed, with a dedication to safeguarding patient
well-being. In cases where the nonconformity poses a significant risk, it's escalated to the
appropriate authority.

8.7.1.b Understanding the Root Cause

a) Identifying Causes: The laboratory diligently investigates the root cause(s) of the
nonconformity. This step is crucial in uncovering the underlying factors that led to the
deviation from established standards.

8.7.1.c Corrective Actions to Prevent Recurrence

a) Assessing the Need: To prevent the recurrence of nonconformities and their occurrence
elsewhere, the laboratory assesses the necessity of corrective action. This assessment
includes a thorough review and analysis of the nonconformity, a search for similar
occurrences or potential risks, and an evaluation of the potential consequences if the
nonconformity were to happen again.
b) Implementation: If corrective action is deemed necessary, the laboratory promptly
implements these actions. This step involves putting in place measures and changes to
eliminate the root cause of the nonconformity, thereby reducing the likelihood of it
happening again.

8.7.1.d Evaluation and Improvement

a) Effectiveness Review: After implementing corrective actions, the laboratory evaluates
their effectiveness. This assessment gauges whether the actions taken have effectively
resolved the issue and reduced the likelihood of recurrence.

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b) Adapting the System: If required, changes are made to the management system based
on the lessons learned from the nonconformity. These adaptations ensure that the system
evolves and becomes more robust in preventing and managing similar situations.
Through this comprehensive approach, the laboratory not only addresses
nonconformities promptly but also continually enhances its management system to
maintain the highest standards of quality and patient safety.
8.7.2 Corrective Action
8.7.2. Appropriate Response:
Corrective actions: undertaken are proportionate and appropriate to the effects of the
nonconformities encountered. This ensures that the response adequately addresses the identified
cause(s) of the nonconformity.
8.7.3 Records of Nonconformities and Corrective Actions
Detailed Record-Keeping:
The laboratory is committed to maintaining comprehensive records that serve as evidence of:
a) Nature of Nonconformities: These records detail the nature and specifics of the
nonconformities encountered. They provide a clear picture of what went wrong or
deviated from established standards.

Cause(s) Identification: Records also document the cause(s) behind the

nonconformity. This helps in understanding the root factors that led to the deviation.

Subsequent Actions Taken: Any and all actions taken to address the nonconformities
are meticulously recorded. This includes the measures implemented to correct the issue
and prevent its recurrence.

b) Evaluating Corrective Action Effectiveness:

In addition to documenting nonconformities and the actions taken, these records also
encompass evaluations of the effectiveness of the corrective actions. This evaluation is
critical in determining whether the steps taken have successfully mitigated the identified
cause(s) and prevented the nonconformity from happening again.
Through robust record-keeping, the laboratory maintains transparency and
accountability in its quality management processes. These records serve as a valuable
resource for internal evaluations, compliance assessments, and continual improvement
efforts.

ASSOCIATED PROCEDURE:Quality Management System Procedure for

controlofnon-conformity & corrective action (WMHL/QMSP/14.).
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8.8 Evaluations: Ensuring Consistent Quality
8.8.1 General (Regular Evaluations for Continuous Quality Assurance)
8.8.1Ongoing Evaluations:
The laboratory places a strong emphasis on the regular conduction of evaluations. These evaluations
are systematically carried out at planned intervals. Their primary purpose is to demonstrate that all
aspects of the management system, including management, support, and the pre-examination,
examination, and post-examination processes, effectively meet the needs and requirements of both
patients and laboratory users. Furthermore, these evaluations serve as a crucial means of ensuring
strict conformity to the requirements laid out in this document.

8.8.2 Quality indicators (Monitoring Quality Indicators for Enhanced Performance)

8.8.2. Planned Quality Indicator Monitoring:
As part of the quality assurance process, the laboratory rigorously monitors a set of predefined
quality indicators (as specified in [see 5.5 d)]). This monitoring process is meticulously planned
and encompasses several key elements:
 Establishing Objectives: Clear objectives are set, defining what needs to be achieved
through this monitoring process.
 Methodology: The methodology for monitoring quality indicators is well-defined,
ensuring consistency and accuracy in data collection.
 Interpretation: Procedures for interpreting the data obtained from monitoring are
established. This involves assessing whether the performance meets established
standards and criteria.
 Setting Limits: Clearly defined limits are established to distinguish between acceptable
and unacceptable performance.
 Action Plan: In case of deviations from established standards, an action plan is in place
to address the issues and make necessary improvements.
 Duration of Monitoring: The laboratory determines how long the monitoring of these
quality indicators will continue, ensuring that it remains an ongoing and consistent
practice.
Periodic Review for Continuous Relevance:
To maintain the effectiveness of the quality indicator monitoring process, the laboratory
periodically reviews all aspects of this practice. This includes the objectives, methodology,
interpretation procedures, limits, action plan, and the duration of monitoring. These reviews
are crucial to ensure that the quality indicators remain appropriate, relevant, and aligned with
the evolving needs and standards of the laboratory and its stakeholders. Through this rigorous
evaluation, the laboratory continuously enhances its performance and the quality of its services.

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8.8.3 Internal Audits: Ensuring Adherence and Effectiveness

8.8.3.1 Comprehensive Internal Audits for Insightful Evaluation
The laboratory recognizes the paramount importance of conducting internal audits as an
integral part of its quality management system. These internal audits are carried out at
planned intervals with a multifaceted purpose:
a) Adherence to Laboratory's Own Requirements: These internal audits
meticulously assess whether the laboratory's management system, inclusive of
all laboratory activities, aligns with its own established requirements. This is
essential to ensure that the management system is fully aligned with the
laboratory's internal standards and expectations.
b) Conformity to Documented Standards: The internal audits are designed to
rigorously scrutinize the extent to which the management system complies with
the specific requirements outlined in this document. This meticulous
examination ensures strict adherence to external standards, contributing to the
laboratory's overall credibility.
c) Effectiveness of Implementation and Maintenance: Beyond mere conformity,
the internal audits delve deeper into the practical aspects of the management
system. They evaluate the effectiveness of its implementation and ongoing
maintenance. This holistic assessment ensures that the system not only meets the
required standards on paper but also operates effectively in practice.
These internal audits serve as a valuable source of information and insights,
providing the laboratory with a comprehensive view of the current state of its
management system. This, in turn, empowers the laboratory to make informed
decisions, implement necessary improvements, and ensure the highest levels of
quality and compliance in its operations.

8.8.3.2 Crafting a Methodical Internal Audit Programme

The laboratory recognizes the pivotal role of an organized internal audit programme in its
quality management system. This programme is meticulously planned, established,
implemented, and maintained, featuring the following essential elements:
a) Prioritizing Patient Safety: The internal audit programme gives paramount
importance to patient safety. It assesses and prioritizes risks stemming from
laboratory activities, ensuring that these assessments are aligned with the ultimate
goal of safeguarding patients.

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b) A Thoughtful Schedule: The programme adheres to a well-thought-out schedule,
taking into account various factors:

 Identified Risks: Risks are identified, evaluated, and factored into the audit
schedule.
 External Evaluations: Findings from external evaluations are taken into
consideration, further enhancing the relevance of internal audits.
 Past Internal Audits: Insights from previous internal audits are incorporated
into the planning process.
 Incidents and Complaints: Any incidents, complaints, or nonconformities are
examined, and necessary actions are implemented.
 Adapting to Changes: The programme remains adaptable to changes that may
impact laboratory activities. This ensures that audits are always aligned with the
laboratory's current operational landscape.
c) Well-Defined Audit Objectives: Each internal audit within the programme is
equipped with specific, well-defined objectives, criteria, and scope. This clarity
ensures that auditors are focused on assessing critical aspects of the management
system.
d) Competent Auditors: The selection of auditors is a meticulous process. Auditors are
not only trained and qualified but also authorized to assess the performance of the
laboratory's management system. Wherever feasible, auditors are independent of
the activities they audit, ensuring impartiality.
e) Objectivity and Impartiality: The audit process prioritizes objectivity and
impartiality, ensuring that audits are conducted without bias or influence.
f) Reporting and Accountability: Audit results are reported comprehensively to
relevant personnel. This reporting mechanism enhances transparency and
accountability within the laboratory.
g) Swift Corrective Actions: The programme ensures that necessary corrections and
corrective actions are swiftly implemented when audit findings warrant such
actions.
h) Retaining Evidence: Records that serve as evidence of the audit programme's
implementation and the results of each audit are retained. These records contribute
to a comprehensive audit trail and compliance documentation.
This structured internal audit programme is a critical component of the laboratory's
commitment to continual improvement, ensuring that its management system

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remains robust, effective, and aligned with the highest standards of quality and
patient safety.

ASSOCIATED PROCEDURE: Nil

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Doc No. QUALITY MANUAL Section No.: QMS 8.9
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8.9. Management Reviews
8.9.1 General
The cornerstone of the laboratory's commitment to maintaining a top-tier management system
is the regular management reviews conducted at planned intervals. These reviews serve a vital
purpose:
a) Suitability, Adequacy, and Effectiveness: During these reviews, laboratory management
thoroughly evaluates the management system's continuing suitability, adequacy, and
effectiveness. This comprehensive assessment encompasses all aspects of the system,
including the policies and objectives aligned with the fulfilment of this document.
This systematic examination ensures that the management system remains aligned with the
laboratory's evolving needs and the requirements set forth in this document. It also provides a
platform for identifying areas where improvements may be needed.
These reviews are not mere formalities but a dynamic process that drives the laboratory's
commitment to excellence, patient safety, and quality assurance. They ensure that the
management system consistently aligns with the laboratory's objectives and the highest
standards of care.
Through these reviews, the laboratory renews its dedication to delivering the best possible
service to patients and users. It's a proactive approach to maintain, adapt, and enhance the
management system to meet the ever-evolving challenges and opportunities in the medical
field. This commitment to ongoing excellence sets the laboratory apart as a leader in
healthcare quality.
8.9.2 Review Input:
To ensure effective management reviews, it's crucial to gather and record a broad range of
inputs. These inputs offer a well-rounded understanding of the laboratory's performance and
the management system's effectiveness. Key components of the review input include:
a) Status and Changes: Management review inputs begin by examining the status of
actions initiated following previous reviews. It also considers any internal and external
changes impacting the management system. These changes may involve shifts in
laboratory activities, resource allocation, or alterations to procedures. The aim is to
assess how well the laboratory has adapted to evolving circumstances and
opportunities for improvement.
b) Fulfilment and Suitability: A central focus of the review is the extent to which the
laboratory has fulfilled its objectives and the suitability of its policies and procedures.
This assessment helps ensure that the laboratory's actions align with its stated goals
and that the established policies and procedures remain effective and relevant.

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c) Evaluation Outcomes: Recent evaluations play a pivotal role in the review process.
This includes evaluations from various sources, such as process monitoring using
quality indicators, internal audits, analyses of non-conformities, and corrective actions
taken. Insights from assessments by external bodies are also considered. These
evaluations provide a comprehensive picture of the laboratory's performance and
highlight areas that require attention.
d) Stakeholder Feedback: Input from patients, users, and personnel is invaluable.
Feedback and complaints from these stakeholders provide real-world insights into the
laboratory's services and any concerns that need addressing. Their feedback ensures
that the laboratory remains responsive to the needs and expectations of those it serves.
e) Quality Assurance: Ensuring the validity of results is paramount in laboratory
operations. The review includes an evaluation of quality assurance measures to confirm
the reliability of test results. This is essential for maintaining patient safety and the
credibility of the laboratory's services.
f) Improvement Assessment: The effectiveness of improvements implemented since the
last review is rigorously assessed. It's vital to understand whether these actions have
yielded the desired results and contributed to addressing identified risks and
opportunities for improvement.
g) External Providers: The performance of external providers, whose services may
impact the laboratory, is scrutinized. This evaluation ensures that external partners are
meeting the laboratory's standards and expectations.
h) Participation in Comparison Programs: Participation in interlaboratory comparison
programs is assessed to determine the laboratory's performance relative to peer
institutions. This external benchmarking aids in identifying areas for improvement.
i) POCT Activities: For laboratories involved in point-of-care testing (POCT), an
evaluation of these activities is integrated into the review process.
j) Other Relevant Factors: Finally, other factors, such as monitoring activities and
training initiatives, are considered during the review. These factors can significantly
influence the laboratory's overall performance.
By gathering this comprehensive set of inputs, the management review process is well-
informed and equipped to drive meaningful improvements in the laboratory's
management system, ensuring the highest quality of patient care and safety.

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8.9.3 Review Output:
After conducting the management review, it's essential to translate insights and discussions
into tangible decisions and actions. The review output comprises a record of these decisions
and actions, which pertain to several critical areas:
a) Assessing System and Process Effectiveness: One of the primary outcomes is an
evaluation of the management system's effectiveness and the efficiency of its processes.
This assessment helps pinpoint areas where improvements are needed to enhance
overall system performance.
b) Enhancing Laboratory Activities: To continually improve laboratory activities,
decisions and actions are formulated based on the review. This focuses on aligning
laboratory practices with the requirements specified in this document. By identifying
areas for enhancement, the laboratory can better fulfill its obligations and maintain
high standards.
c) Resource Allocation: Adequate resources are essential for maintaining quality in
laboratory operations. The review output includes decisions regarding the provision of
necessary resources. This ensures that the laboratory has the tools, personnel, and
infrastructure required to function optimally.
d) Elevating Patient and User Services: Improving services to patients and users is a
paramount objective. Decisions and actions arising from the review are geared towards
enhancing the overall quality of services provided. This may involve refining processes,
upgrading technology, or implementing new practices that directly benefit those
relying on the laboratory's services.
e) Recognizing the Need for Change: As circumstances evolve and new challenges
emerge, the need for change becomes apparent. The management review identifies
areas where change is required to adapt to shifting demands or seize new
opportunities. These changes may encompass adjustments to policies, procedures, or
resource allocation.
Additionally, it is imperative that laboratory management ensures that actions arising
from the management review are not only well-defined but also executed within
specified timeframes. This timely implementation is critical for addressing issues
promptly and making continuous improvements.
Furthermore, conclusions and actions emanating from the management review should
be effectively communicated to laboratory personnel. Clear communication ensures
that all relevant stakeholders are aware of the decisions made and the actions to be
taken. This transparency fosters a collaborative environment where everyone plays a

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role in achieving the laboratory's objectives and maintaining high standards of quality
and patient care.

ASSOCIATED PROCEDURE: NIL

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Doc No. QUALITY MANUAL Section No.:
WMHL/PATH/QM/01 APPENDIX- I
ISO 15189:2022
PERSONNEL INTER-RELATIONSHIP MATRIX

APPENDIX- I
Sl Function CP/ QM Consultant Receptionist Technician
no LD
1. Quality Management S P S S S
System
2. Document control S P S S S
3. Records S P S S S
4. Quality Policy P S S S -
5. Service Agreements P - S P S
6. Purchase P S - - S
7. Complaint P P P -
8. Control of non- P S P - S
conformity of testing &
corrective action
9. Preventive Action P P - - -
10. Internal Audit - P S - -
11. Management Review P P S - -
12. Training P P S - -
13. Test Method P S P - S
14. Maintenance P S S - P
15. Calibration P S S - S
16. Sample Handling S S S - P
17. Quality Control P P P - S
18. Reporting of Result P P P - S

Consultant Pathologist (CP)

Quality Manger (QM)

P= Primary Responsibility
S= Secondary Responsibility

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Doc No. QUALITY MANUAL Section No.:
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ISO 15189:2022

LIST OF ASSOCIATE DOCUMENT

TITLE /DOCUMENT Clause No

SL. NO. TITLE/DOCUMENT
NUMBER

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

1. WMHL/QMSP/01 6.2.5
PERSONNEL MANAGEMENT AND TRAINING
PROCEDURE FOR EQUIPMENT SELECTION,
2. INSTALLATION, HANDLING, MAINTENANCE AND WMHL/QMSP/02 6.4
DECOMMISSIONING AND RECALL NOTICE
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
3. ADVERSE INCIDENT REPORTING WMHL/QMSP/03 6.4.6

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

4. METEOROLOGICAL TRACEABILITY & CALIBRATION OF WMHL/QMSP/04 6.5.2
THE EQUIPMENT’S
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
5. WMHL/QMSP/05 6.6.1 – 6.6.5
STORAGE AND INVENTORY MANAGEMENT

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

6. WMHL/QMSP/06 6.6.6
CONSUMABLES — ADVERSE INCIDENT REPORTING

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

7. WMHL/QMSP/07 6.7.1
REVIEW OF SERVICE AGREEMENTS
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR EXTERNA
8. PROVIDED PRODUCTS AND SERVICES SELECTION, REVIEW AWMHL/QMSP/08 6.8.3
EVALUATION

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR 7.2.1, 7.2.3.2,

9. WMHL/QMSP/09
PRE-EXAMINATION PROCESSES 7.2.4.1,
7.2.6.1, 7.2.7.1
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
10. WMHL/QMSP/10 7.3.2
VERIFICATION OF EXAMINATION METHODS

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

11. WMHL/QMSP/11 7.3.7.1
ENSURING THE VALIDITY OF EXAMINATION RESULTS

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ISO 15189:2022

LIST OF ASSOCIATE DOCUMENT

TITLE /DOCUMENT Clause No

SL. NO. TITLE/DOCUMENT
NUMBER

PROCEDURE FOR PATIENT COMMUNICATION IN CASE

12. WMHL/QMSP/12 7.4
OF DELAY OF TEST RESULTS
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
13. REVIEW AND RELEASE AND AMENDMENT OF WMHL/QMSP/13 7.4
EXAMINATION RESULTS
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
14. NON-CONFORMING WORK AND ITS CORRECTIVE WMHL/QMSP/14 7.5
ACTION
QUALITY MANAGEMENT SYSTEM PROCEDURE FOR
15. WMHL/QMSP/15 7.7
HANDLING OF FEEDBACK AND CUSTOMER COMPLAINT

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

16. WMHL/QMSP/16 8.3
DOCUMENT CONTROL

QUALITY MANAGEMENT SYSTEM PROCEDURE FOR

17. WMHL/QMSP/17 8.4
RECORDS

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WMHL/PATH/QM/01 APPENDIX- III
ISO 15189:2022

ORGANISATION CHART

Director

Medical Superintendent

Chief of Laboratory Services /

Biochemist / Human
Laboratory Director
Pathologist / Resource
Microbiologist (HR)
Biomedical
Engineer

Quality Manager/ Technician

Purchase I/C
Dy. Quality
Manager
Technician
Phlebotomist
Receptionist
/ Typist
Lab
Assistants Lab
Attendant

Note: One of the Technician is performing as Dy. Quality Manager.

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