Draft QM 17025 2017

Document No.
Issue No. 01
Date 01-08-2018
Quality Manual
Reference Standard
Issue Number
Issue Date
Copy Number
Total Pages
Issued To
Address
Prepared By Approved By Issued By
Name
Designation Quality Manager CEO Quality Manager
Page 1 of 59
Amendment No. 00 Amendment Date == Copy No.

Document No.
Issue No. 01
Date 01-08-2018
This Quality Manual is released under

the authority of
Page 2 of 59

Document No.
Issue No. 01
Date 01-08-2018
Chapter 1.0 General Information

1.1 Table of contents
Amend
Chapter Subject ISO/IEC 17025
ment Page No.
No. Clause Ref.
No.
Cover page, table of contents, amendment record sheet
1 00 1-6 ==========
and glossary of terms (abbreviation)
Authorization statement and laboratory profile and
2 00 7-9 ==========
context of organization
3 Control and distribution 00 10 - 11 ==========
General requirements
4.0 4.1 Impartiality 00 12 - 13
4.0
4.2 Confidentiality 00 14
5.0 Structural requirements 00 15 - 20 5.0
Resource requirements
6.1 General 00 21
6.2 Personnel 00 21 - 22
6.0 6.3 Facilities and environmental conditions 00 23 6.0
6.4 Equipment 00 24 - 26
6.5 Metrological traceability 00 27
6.6 Externally provided products and services 00 28 - 29
Process requirements
7.1 Review of requests, tenders and contracts 00 30 - 31
7.2 Selection, verification and validation of methods 00 32 - 34
7.3 Sampling 00 35
7.4 Handling of test or calibration items 00 36
7.5 Technical records 00 37
7.0 7.0
7.6 Evaluation of measurement uncertainty 00 38
7.7 Ensuring the validity of results 00 39 - 40
7.8 Reporting of results 00 41 - 43
7.9 Complaints 00 44
7.10 Nonconforming work 00 45
7.11 Control of data - Information management 00 46
Page 3 of 59
Quality Manager CEO Quality Manager

Document No.
Issue No. 01
Date 01-08-2018
1.1 Table of contents
Chapter Amend
Subject ISO/IEC 17025
ment Page No.
No. Clause Ref.
No.
Management system requirements
8.1 Options 00 47
8.2 Management system documentation (Option A) 00 47 - 48
Control of management system documents
8.3 00 49 - 51
(Option A)
8.4 Control of records (Option A) 00 52
8.0 8.0
Actions to address risks and opportunities
8.5 00 53
(Option A)
8.6 Improvement (Option A) 00 54
8.7 Corrective action (Option A) 00 55
8.8 Internal audits (Option A) 00 56
8.9 Management reviews (Option A) 00 57
Annexure
ANX-1 List of documents 00 58 - 59 ==========
Note The amendment number given above is at the time of issue of this manual. If any page is
amended then latest amendment number of such pages is recorded in amendment record
sheet and on the table of content given above.
Page 4 of 59

Document No.
Issue No. 01
Date 01-08-2018
1.2 Amendment record sheet

Sign. of
Amd. Amd. Issue Issue Page Chapter Amendment made Reasons of
authorized
No. Date no. date No. no. amendment
person
Note :-
(I.) All the pages of this Quality Manual are currently as per Issue no. 01 and Amendment no. 00,
except pages listed in the above table. The pages addressed above are amended with the
identification of amendment no. and date of amendment in this table as well as in the footer.
(II.) To check the validity of the complete manual, confirm current revision and amendment status
of this page with Quality Manager and cross-check with sheets changed.
Page 5 of 59

Document No.
Issue No. 01
Date 01-08-2018
1.3 Glossary Of Terms (Abbreviations)

Sr.
Abbreviation For
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Page 6 of 59

Document No.
Issue No. 01
Date 01-08-2018
Chapter 2.0 Authorization Statement and XYZ Profile

2.1 Authorization Statement
XYZ is committed to the establishment and maintenance of management system given in this
manual and implemented by the XYZ, to meet the requirements of ISO/IEC 17025:2017.
The members of the XYZ strictly adhere to the various quality procedures and work instructions /
standard operating procedures, as supported by the policies outlined in this manual.
ABC has been appointed as Quality Manager and ABCD himself has
been appointed as Technical Manager of XYZ. The Quality Manager is responsible for ensuring
compliance with the quality requirements stipulated in this manual. Quality Manager is authorized to
ensure that the management system is established, implemented, and maintained by the XYZ,
CEO, Technical Manager, and XYZ employees give full support and co-operation to Quality
Manager. Technical Manager assumes responsibility of Quality Manager and Quality Manager
assumes the responsibility of Technical Manager in their absence. Technical Manager is responsible
for ensuring compliance with the technical requirements in the Testing/calibration activities.
Page 7 of 59

Document No.
Issue No. 01
Date 01-08-2018
2.2 Company Profile
Page 8 of 59

Document No.
Issue No. 01
Date 01-08-2018
2.3 Context of organization

Internal issues
1. Impartiality to the laboratory activities
2. Reporting statement of conformity against defined risk
3. Nonconforming Testing/calibration work
4. Maintaining competence of Testing/calibration personnel as well as employees’ turnover
External issues
1. Confidentiality of customer’s information
2. Customer dissatisfaction
3. Market reputation
4. Legal issues
2.4 Testing/calibration facilities covered in ISO/IEC 17025:2017 Scope

1.
Scope of Accreditation
.
Page 9 of 59

Document No.
Issue No. 01
Date 01-08-2018
3.0 Controls and Distribution

3.1 Structure of Quality Manual
This manual is prepared according to the table of contents. Cover page begins with page
no. 1 and the numbering continue throughout the manual.
The manual is supported by documented management system covering Quality
Procedures (QP) and work instructions or test methods. The procedure is referred in the
relevant chapters of this manual. In addition, a separate list of chapter-wise procedures
referred in this manual is given in Annexure-1 and a glossary of terms is given in clause
no. 1.3.
The manual is issued in loose paper sheets and is accessible to the staff and customers.
The implementation of this manual and related quality procedure is mandatory for all
departments. Any changes made in this manual shall be affected through the document
control procedures and must be approved by the CEO.
3.2 Responsibility
CEO approves all the pages of the Quality Manual. The control and maintenance of this
manual is the responsibility of Quality Manager, who is maintaining master list of
documents for quality manual.
3.3 Reference
ISO/IEC General requirements for the competence of Testing/calibration
17025:2017 and
Calibration Laboratories
Quality Procedure
3.4 Distribution
Quality Manuals are distributed to various departments on a "controlled" basis. Controlled
copies are the one, which are subject to incorporation of "revisions".
"Controlled" copies of the quality manual are stamped “Controlled Copy” on all pages
and are given a unique copy number for maintenance purpose.
Distribution list of Quality Manual is given on the next page.
Quality Manager, through a “change note” issues amendments and revised pages of
quality manual to holders of controlled copies of the manual. Upon receipt of such
revisions, the recipient will replace the pages by the revised ones.
"Uncontrolled" copies may be issued by the Quality Manager to the customers on
request of the Technical Manager, or Functional Head to all employees but the recipient
shall not be issued the amendments / revisions.
Quality Manager is responsible to fill-up amendment sheet in line with any amendment
and put “Controlled Copy” Stamp on the amendment sheet as well as table of contents.
All the information regarding revisions is distributed to Copy Holders. If any amendment
due to change in page number is done then the table of contents is amended
accordingly.
Page 10 of 59

Document No.
Issue No. 01
Date 01-08-2018
3.5 Distribution list of Quality Manual

Copy No. Type of document Distributed to
1 Controlled Copy
2 Master Copy
3 Controlled copy
4 Controlled copy
======== Uncontrolled copy
3.6 Numbering and document control for Quality Manual
(1.) The number for Quality Manual is given as QM/01, where QM stands for Quality Manual
and 01 stands for 1st level document.
(2.) When any amendment becomes necessary, it is the affected page that is replaced and
not the whole chapter. The revised page is given amendment no. and amendment date in
the footer as well as in the amendment record sheet of Chapter -1.
(3.) Revised pages of the Quality Manual are subject to the same approvals and controls as
per the original one. In case of amendments to the particular page the amendment no.
and amendment date for the particular page is identified on the footer of the amended
page. After more than nine amendments in a single page the whole issue number of
Quality Manual is revised with new issue number with amendment no. as 00.
3.7 Reference to related documents
1. Amendment record sheet (Clause No. 1.2) - Chapter - 1.
Page 11 of 59

Document No.
Issue No. 01
Date 01-08-2018
4 General requirements
4.1 Impartiality
4.1.1 Laboratory activities are undertaken impartially and they are structured and managed, so
as to safeguard impartiality. To ensure impartiality, the Testing/calibration personnel and
administration personnel are separate. The organization structure is given on the next
page, which ensures that impartiality related to work is carried-out by the laboratory.
The Quality Manager ensures impartiality by the laboratory during the laboratory
subcontractors’ and employees’ relation with customers during execution of the work.
4.1.2 XYZ management is committed to impartiality and impartiality policy (------) is
prepared and communicated to all. Procedure (QP/) is prepared for maintaining
impartiality of laboratory activities and is followed to maintain impartiality.
4.1.3 XYZ is independent laboratory, dealing in the DEF Testing/calibration. XYZ is responsible for
the impartiality of its activities and the matter related to commercial, financial or other
pressures to compromise impartiality is handled by the personnel other than the
Testing/calibration personnel. Testing/calibration person is not in the direct contact with the
customer. Receipt of sample, billing, payment collection, etc. activities is undertaken
by administration personnel. Employees are not given more work which can create
pressure on them to ensure no compromise in the Testing/calibration activities.
4.1.4 XYZ has identified risks to its impartiality on an on-going basis from customer,
employees and suppliers. This includes those risks that arise from its activities, or from its
relationships, or from the relationships of its personnel. However, such relationships are not
necessarily present at XYZ with a risk to impartiality. A relationship that threatens the
impartiality of XYZ, is on ownership (as the Head of XYZ does not have any other
business, he is engaged in the Testing/calibration activities only), governance, management,
personnel
(technical and administration personnel are separate), shared resources (all resources for
the Testing/calibration are owned by laboratory; as a policy, it is decided that the resource
of customer
will not be used in any case for undertaking the customer’s Testing/calibration job), finances
(separate
and dedicated finance is allotted for Testing/calibration laboratory), contracts, marketing
(including
branding etc. not applicable). The other activities like, payment of a sales commission or
other inducement for the referral of new customers etc. are not done as a part of policy.
Impartiality policy, its requirements and its norms are communicated to all laboratory
personnel by:
To all employees By providing training related to requirements of impartiality,
To all sub-contractors / external service providers By signing the confidentiality and
impartiality agreement (F/PUR/07).
4.1.5 If a risk to impartiality is identified, XYZ will take appropriate action to eliminate or
minimize such risk by deploying separate personnel, by providing separate or dedicated
resources etc. CEO initiates the immediate actions to overcome and take action to maintain
impartiality.
Page 12 of 59

Document No.
Issue No. 01
Date 01-08-2018
Organization Chart
Directors
CEO and Technical Manager
General Manager and Quality Manager
Mobile Laboratory Incharges
Mobile Laboratory Operators
Remarks
Technical Manager is nominated as Deputy Quality Manager.
Quality Manager is nominated as Deputy Technical Manager.
Page 13 of 59
Ms. G. Kastury Mr. G. Kameswara Rao Ms. G. Kastury
Document No.
Issue No. 01
Date 01-08-2018
4.2 Confidentiality
4.2.1 The confidentiality agreement is made with the employees and other parties to ensure
protection of its customers' confidential information, proprietary rights as well as test
results. All care is taken to ensure files are transmitted in non-edited form to the customer
and all care for confidentiality is taken in electronic storage and transmission of results.
XYZ is responsible, through legally enforceable commitments (based on the contract
made with the customer, either in customer order or in the Sample test request slip -
F/QCD/02), for the management of all information obtained or created during th e
performance of Laboratory activities. XYZ informs the customer in advance, of the
information it intends to place in the public domain. Except for information that the customer
makes publicly available, or when agreed between XYZ and the customer (e.g. for the
purpose of responding to complaints), all other information is considered proprietary
information and is regarded as confidential. All employees of the laboratory activities have
signed confidentiality agreement (F/TRG/06) to ensure that confidentiality of customer’s
information is maintained. All sub-contractors / external service providers have signed
confidentiality and impartiality agreement (F/PUR/07).
4.2.2 When XYZ is required by law or authorized by contractual arrangements to release
confidential information, XYZ will inform the details of information shared to the
customer or individual concerned. The customer is informed in writing for such incidence.
4.2.3 Information about the customer, obtained from sources other than the customer (e.g.
complainant, regulators), is kept confidential between the customer and XYZ The
provider (source) of this information is kept confidential to XYZ and is not shared with the
customer, unless agreed by the source.
4.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on behalf of XYZ, ensure that all information obtained or created during
the performance of Laboratory activities, except as required by law, are strictly kept
confidential.
Reference documents
E/SYS/03 Secrecy rules
F/TRG/06 Confidentiality agreement
F/PUR/07 Sub-contractors / External service provider’s agreement
Page 14 of 59
Document No.
Issue No. 01
Date 01-08-2018
5 Structural requirements
5.1 XYZ is registered as Private Limited company as a legal entity. The legal registration
details of the XYZ are as below;
XYZ is legally registered as a Private Limited company as below:
Registrar of Companies, incorporated under the Companies Act,
Registered with
1956 (No. 1 of 1956)
Registration no. U17200AP2014PTC095890
Registration date 24-12-2014
5.2 CEO (as a Head of Laboratory) has overall responsibility for Laboratory activities carried-
out at the mobile facility. As XYZ is conducting the Testing/calibration in the mobile
laboratory only, hence the requirements of permanent facility and site Testing/calibration is
not applicable.
5.3 XYZ has defined and documented the range of Laboratory activities, such as Testing/calibration
of DEF at mobile facility. Permanent facility and site Testing/calibration is not applicable.
All such details are given in E/SYS/07. All activities carried-out comply with the
requirements given in ISO/IEC 17025 (this document). XYZ claims conformity only for the
defined scope of accreditation, which excludes externally provided activities on an ongoing
basis.
5.4 Laboratory activities are carried-out in such a way as to meet the requirements of
ISO/IEC 17025, relevant test standards, customer requirements, regulatory authorities and
organizations providing recognition / accreditation, such as Accreditation Body. This
includes Laboratory activities performed in mobile facilities only. No Testing/calibration is
carried-out
at permanent facility as well as site, and hence, the requirement is not applicable.
5.5 XYZ has:
a) defined the organization and management structure of XYZ, and the relationships
between management, technical operations and support services. The organization
structure is given at the end of clause no. 4;
b) specified the responsibility, authority and interrelationship of all personnel who manage,
perform or verify work affecting the results of Laboratory activities. Detailed job
description and specifications (F/TRG/04) are prepared for each level of employees and
communicated to all personnel within the laboratory. The responsibilities and authorities
of key personnel are given at the end of clause no. 5.0.
c) documented its procedures as identified in successive clauses, to the extent necessary,
to assure the consistent application of its Laboratory activities and the validity of the
results reported to the customer for the materials.
5.6 XYZ have personnel (Quality Manager and Technical Manager) who, irrespective of
other responsibilities, have the authority and resources needed to carry-out their duties,
including:
a) implementation, maintenance and improvement of the management system as per
ISO/IEC 17025;
b) identification of deviations from the management system or from the procedures for
performing Laboratory activities;
Page 15 of 59
Document No.
Issue No. 01
Date 01-08-2018
c) initiation of actions to prevent or minimize such deviations;
d) reporting to XYZ management on the performance of the management system and
any need for improvement;
e) ensuring the effectiveness of Laboratory activities.
5.7 XYZ management ensures that:
a) communication (through written communication as per the E/SYS/04) takes place
regarding the effectiveness of the management system and the importance of meeting
customers' and other requirements. Method of communication is effectively
implemented related to management system within the laboratory. In majority of the
cases, the communication is done through routine records for effective implementation
and e-mail to the concerned.
b) the integrity of the management system is maintained when changes to the

management system are planned and implemented. Also it is ensured that the integrity
of management system is maintained, when changes are planned and implemented in
the system. In key position, the deputies are nominated to take care of the person
related issues.
Reference documents
E/SYS/04 Communication process
E/SYS/07 Scope of accreditation
F/TRG/04 Job description and specification
Page 16 of 59
Document No.
Issue No. 01
Date 01-08-2018
Responsibility and authority of the Top Management (CEO)

Responsibility
To provide resource for effective implementation of the system.
To conduct the management review meeting periodically, and to ensure that the system is
effectively implemented within the laboratory.
To nominate Quality Manager and Technical Manager as per the requirements of the system.
To prepare and review Quality Policy periodically, and to ensure that the same is in line with the
present circumstances.
To provide evidence of commitment to the development and implementation of management
system and continual improvement and its effectiveness.
To communicate the importance of meeting customer as well as statutory and regulatory
requirements within the organization.
To ensure that the integrity of the management system is maintained during changes to the
management system as planned and implemented.
Authority
To stop the activity, if found any non-conformity related to Testing/calibration,
accommodation and
environment.
Page 17 of 59
Document No.
Issue No. 01
Date 01-08-2018
Responsibility and authority of Quality Manager

Responsibility
To review and approve the management system documents.
To ensure that a management system is established implemented and maintained in
accordance with the ISO/IEC 17025 management system standards.
To ensure that the continual improvement is going on after implementing the system.
To liaise with Accreditation Body for all the matters related to accreditation.
To record the minutes during the management review meeting.
Overall responsible for the document control.
To establish control over document and data, including documents of external origin (such as
Indian Standards / International Standard, etc.).
To schedule and arrange internal audits on the basis of status and importance of the functions.
To establish control system on quality and technical records.
To identify causes of non-conformities and take necessary corrective actions to remove the
cause.
To identify training needs of employees for the management system.
Overall responsible for maintaining of training records in consultation with Technical Manager.
To prepare records of technical training of the employees.
To identify the corrective action based on the analysis of complaints.
To do data analysis and identify fruitful results for the further improvement.
To conduct the analysis of customer feedback and to identify the customer satisfaction level.
Overall responsible for establishing and maintaining of system based on ISO/IEC 17025.
Authority
To stop the activity, if found any non-conformity related to Testing/calibration,
accommodation and
environment.
To review all the non-conformities raised during the audit and issue report to the auditee for
taking actions.
To approve the actions taken by the auditee as a basis to resolve non-conformities.
To suggest corrective actions related to the system improvement.
To monitor whole documented system and suggest preventive actions, if anything goes wrong.
Page 18 of 59
Document No.
Issue No. 01
Date 01-08-2018
Responsibility and authority of Technical Manager

Responsibility
To ensure that the documented test/ calibration methods / reference standards are followed
during the Testing/calibration.
To prepare four-year plan and to follow the requirements for ensuring the validity of results.
To identify the training needs of the employees and provide the same in consultation with the
Quality Manager.
To ensure that proper accommodation and environment is maintained in the Testing/calibration
area as per
the requirements of the relevant test standards.
To initiate corrective actions based on the feedback of the Testing/calibration activities.
To ensure periodic monitoring of the environment to maintain records as per the documented
procedure.
To ensure that all the available literatures, including manufacturers manual, are maintained.
To prepare preventive maintenance schedule and intermediate checks schedule for all the
instruments and to ensure that the employees follow the same.
To verify and review test records.
To ensure that calibration of all the equipment are traceable to the national / international
standards and having valid relationship.
To re-calibrate the equipment used in the Testing/calibration before the validity expires.
To ensure optimum use of available resources.
To ensure that the proper records are maintained at all stages of Testing/calibration and quality
control.
To review and authorize daily records of the laboratory.
To ensure safe and proper handling of the samples / materials throughout the laboratory.
To review the print-out from the equipment of each Testing/calibration after completion of necessary
Testing/calibration work.
To provide technical training to the Testing/calibration personnel, as identified.
To ensure that uncertainty of measurement is calculated periodically for each test parameter.
To identify or receive the requirements for consumable purchase from the concerned employees
and to procure the same.
Authority
To review and authorize the routine records of the laboratory.
To review and authorize the Test Report before it is issued to the customer.
To review and approve records of employees’ competence, skills, etc.
To review Calibration Certificates of equipment, received from the outside calibration agency.
To stop the Testing/calibration activities, if proper environment condition is not maintained and
achieved.
To take corrective actions identified based on analysis, related to the complaint or results of
Testing/calibration.
To issue Test Report.
Page 19 of 59
Document No.
Issue No. 01
Date 01-08-2018
Responsibility and authority of Testing/calibration personnel

Responsibility
To check the physical condition of samples received for
Testing/calibration.
To make sample ready for Testing/calibration as per the defined
test method.
To do Testing/calibration of samples as per the documented test method given in the related
Standards. To use equipments for Testing/calibration as referred in the related Standards.
To ensure that the test methods / Standards for Testing/calibration are available where
Testing/calibration activities are
performed.
To conduct the uncertainty of measurement of the samples as per the defined periodicity for the
identified parameters.
To ensure that all required information related to test conducted is adequately available in the
print-out or on the display of computer for High Volume Instrument. Also to ensure that the test
data related to raw DEF is available in the work sheet.
To ensure that HVI test data and work sheet are reviewed by Technical Manager.
To ensure that the equipment used for Testing/calibration is having valid calibration.
To conduct preventive maintenance of the equipments.
To initiate inter-laboratory comparison and to evaluate the results of inter-laboratory
comparison.
To handle breakdown maintenance of the equipment, as soon as possible.
To place the remaining samples retained for the re-test in the sample preservation area and
ensure that the sample is preserved for specified retention period. However, it may be stored for
longer period, if requested by the concerned user / section.
To ensure proper disposal of the sample after retention period as well as after
Testing/calibration, after
receipt of approval from the Technical Manager.
To ensure that the proper records are maintained at all stages of Testing/calibration and
ensuring the
validity of results.
To monitor the environment condition regularly and record the same periodically during the
Testing/calibration activities are carried-out.
To handle the samples throughout the Testing/calibration and preservation in such a way that
it does not
create any problem in Testing/calibration.
To ensure stringent follow-up of the ISO/IEC 17025 system in the lab.
To analyse the complaint by reviewing the related records as per the complaint given by the
Technical Manager.
To report to the Technical Manager on day-to-day functioning / activities.
To use available resources on optimum basis to achieve maximum output during the
Testing/calibration. To reduce wastage of available resources.
Authority
To stop the Testing/calibration activities, if proper environment condition is not maintained / achieved.

Page 20 of 59
Document No.
Issue No. 01
Date 01-08-2018
6 Resource requirements
6.1 General
XYZ has available the personnel, facilities, equipment, systems and support services
necessary to manage and perform its laboratory activities related to Testing/calibration of DEF.
6.2 Personnel
6.2.1 All personnel of the laboratory, either internal or external, that could influence the laboratory
activities act impartially, are competent and work in accordance with the laboratory's
management system. Impartiality policy (E/SYS/05) is prepared and is communicated to
all employees to ensure that all employees act impartially.
6.2.2 XYZ has documented the competence requirements based on the specific criteria
defined by accreditation body, for each function influencing the results of laboratory
activities, including requirements for education, qualification, training, technical knowledge,
skills and experience. All such criteria are documented in the employee competence report
(F/TRG/08).
6.2.3 XYZ ensures that the personnel have the required competence (F/TRG/08), to perform
laboratory activities for which they are responsible and to evaluate the significance of
deviations.
6.2.4 The management of the laboratory communicates to personnel their duties, responsibilities
and authorities in the job descriptions and specifications (F/TRG/04).
6.2.5 XYZ has procedure for the personnel and training (QP/02) and retain records for:
a) determining the competence requirements, considering the requirements of relevant
test parameters covered under the scope of accreditation;
b) selection of personnel for all activities carried-out by laboratory;
c) training of personnel considering the skill and competence requirements;
d) supervision of personnel;
e) authorization of personnel based on the skill and competence;
f) monitoring of competence of personnel.
6.2.6 XYZ has authorized specific personnel to perform specific laboratory activities, including
but not limited to, the following:
a) development, modification, verification and validation of methods; the details of all such
authorization is maintained in the skill matrix (F/TRG/05);
b) analysis of results, including statements of conformity or opinions and interpretations;
the details of all such authorization is maintained in the skill matrix (F/TRG/05);
c) report, review and authorization of results; the details of all such authorization is
maintained in the skill matrix (F/TRG/05);
Such authorization is given based on their competency and details recorded.
Page 21 of 59
Document No.
Issue No. 01
Date 01-08-2018
Reference documents
QP/02 Procedure for personnel and training
F/TRG/01 Training Calendar
F/TRG/02 Training Report
F/TRG/03 Induction Training Report
F/TRG/04 Job Description
F/TRG/05 Skill Matrix (Authorization)
F/TRG/07 Appointment Letter
F/TRG/08 Employees Competence Report
F/TRG/09 ISO/IEC 17025 Effectiveness Check Report
F/TRG/10 Technical Training Effectiveness Check Report
F/TRG/11 Interview Report
F/TRG/12 Self study report for trainer
Page 22 of 59
Document No.
Issue No. 01
Date 01-08-2018
6.3 Facilities and environmental conditions
6.3.1 XYZ has provided the required facilities and environmental conditions suitable for the
mobile Testing/calibration laboratory activities, considering the tests carried-out, and it is
ensured that it does not adversely affect the validity of results. The following parameters
are controlled considering the validity of test results, such as dust, electromagnetic
disturbances, radiation, humidity, electrical supply, temperature, sound and vibration.
The following conditions are maintained in the mobile laboratory;
Sr. No. Parameter Limits
1. Temperature in °C 23 ± 2
2. Humidity in % Rh 65 ± 5
6.3.2 The requirements for facilities and environmental conditions (as above) necessary for the
performance of the mobile laboratory activities are documented.
6.3.3 XYZ monitors, controls and records environmental conditions in accordance with
relevant specifications, methods or procedure (QP/03) or where they influence the validity
of the results. The records of environmental condition monitoring are maintained.
6.3.4 Measures to control facilities are implemented, monitored and reviewed at every month
and these include, but not limited to:
a) access to and use of areas affecting mobile laboratory activities;
b) prevention of contamination, interference or adverse influences on mobile laboratory
activities;
c) effective separation between areas with incompatible mobile laboratory activities.
6.3.5 Site Testing/calibration is not done by XYZ and hence requirement of site Testing/calibration is not
applicable.
The facility provided at mobile laboratory are already documented in 6.3.1 to 6.3.4.
Reference documents
QP/03 Procedure to maintain laboratory environmental condition
F/QCD/08 Environment condition monitoring report
F/QCD/07 Facility supervision checklist
Page 23 of 59
Document No.
Issue No. 01
Date 01-08-2018
6.4 Equipment
6.4.1 XYZ has access to equipment including, but not limited to, measuring instruments,
software, measurement standards, reference materials, reference data, reagents,
consumables or auxiliary apparatus, which is required for the correct performance of
laboratory activities and which can influence the result. A multitude of names exist for
reference materials and certified reference materials, including reference standards,
calibration standards, standard reference materials and quality control materials. Reference
materials from producers meeting the requirements of ISO 17034 come with a product
information sheet / certificate that specifies, amongst other characteristics, homogeneity
and stability for specified properties and, for certified reference materials, specified
properties with certified values, their associated measurement uncertainty and metrological
traceability.
6.4.2 No equipment is used outside the permanent control of mobile laboratory and hence a
requirement of this clause is not applicable.
6.4.3 Procedure (QP/04) for handling, transport, storage, use and planned maintenance of
equipment is prepared and implemented to ensure proper functioning and in order to
prevent contamination or deterioration. It is strictly followed by all persons, during routine
activities.
6.4.4 XYZ verifies that equipment conforms to specified requirements before being placed or
returned into service. The details of checks conducted are recorded in the equipment
history card (F/OPN/01). Equipment history cards are maintained for all the equipments
used in the Testing/calibration.
6.4.5 Equipments used for Testing/calibration (measurement) are capable of achieving the required accuracy
or measurement uncertainty to provide valid test results and have complied with
specifications relevant to Testing/calibration. Calibration schedule (F/SYS/10) is
established for all
equipments, where these properties have a significant effect on the results. Before being
placed into service, equipment are tested or checked to establish that it meets the
specification requirements of XYZ and complies with the relevant standard
specifications. All such calibration details of equipments are reviewed before use.
6.4.6 Measuring equipment are calibrated when:
the measurement accuracy or measurement uncertainty affects the validity of the
reported results, or
calibration of the equipment is required to establish the metrological traceability of the
reported result.
Types of equipment having an effect on the validity of the reported results can include:
those used for the direct measurement of the measurand, for example, use of a
automatic equipment for DEF tests;
those used to make corrections to the measured value, for example, measurement of
temperature and humidity of mobile laboratory, which may affect the measurement;
those used to obtain a measurement result calculated from multiple quantities.
Page 24 of 59
Document No.
Issue No. 01
Date 01-08-2018
6.4.7 XYZ has established a calibration programme (E/SYS/02 and F/SYS/10), which is
reviewed and adjusted as necessary in order to maintain confidence in the status of
calibration.
6.4.8 All equipment requiring calibration or which has a defined period of validity are labeled with
the calibration status sticker having identification no., date of calibration, and due date of
calibration. This helps to allow the user of the equipment to readily identify the status of
calibration or period of validity.
6.4.9 Equipment, which is subjected to overloading or mishandling and gives suspected results, if
showing to be defective or outside specified limits, is withdrawn from operations. It is
isolated to prevent its use and clearly labeled or marked as being “out of service” until it
has been repaired and shown by Testing/calibration to perform correctly within defined
acceptance
criteria. XYZ examines the effect of the defect or departure from specified limits on
previous Testing/calibration, and after that, the same is followed as per the procedure for
management
of non-conforming work.
6.4.10 Defined intermediate check points are established, implemented and are followed as per
the Procedure (QP/05) to maintain confidence in the calibration status of equipment and
Testing/calibration performed by the same equipment. Records of such intermediate
checks are
maintained.
6.4.11 When calibration and reference material data include reference values or correction factors,
XYZ ensures the reference values and correction factors are updated and implemented, as
appropriate, to meet specified requirements.
6.4.12 XYZ takes practicable measures to prevent unintended adjustments of equipment from
invalidating results.
6.4.13 Records are retained for equipment that can influence laboratory activities in the equipment
history card (F/OPN/01), preventive maintenance schedule (F/OPN/02) and calibration
status of equipments (F/SYS/10). The records include the following, where applicable:
a) the identity of equipment (name of equipment), including software and firmware version;
b) the manufacturer's name, type identification, and serial number or other unique
identification;
c) evidence of verification that equipment conforms with specified requirements;
d) the current location;
e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due
date of the next calibration or the calibration interval;
f) documentation of reference materials, results, acceptance criteria, relevant dates and
the period of validity;
g) the maintenance plan and maintenance carried-out to date, where relevant to the
performance of the equipment;
h) details of any damage, malfunction, modification to, or repair of, the equipment.
Page 25 of 59
Document No.
Issue No. 01
Date 01-08-2018
Reference documents
Procedure for handling, transport, storage, use and planned
QP/04
maintenance of equipment
QP/05 Procedure for intermediate checks
E/SYS/02 Calibration periodicity
F/OPN/01 Equipment history card
F/OPN/02 Preventive maintenance schedule
F/OPN/03/XX Equipment-wise preventive maintenance check points
F/QCD/10 Intermediate check report - Weighing balance
F/SYS/10 Calibration status of equipments
Page 26 of 59
Document No.
Issue No. 01
Date 01-08-2018
6.5 Metrological traceability
6.5.1 XYZ has established and maintained metrological traceability of its measurement
results by means of a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty, linking them to an appropriate reference. All equipment used for
sampling, Testing/calibration, including equipment for subsidiary measurements (e.g. for
environmental
conditions), having a significant effect on the accuracy or validity of the results, are
calibrated before being put into service. XYZ has an established program and
procedure for the calibration of equipment (F/SYS/10), procedure no. QP/06 is established
and implemented. The procedure covers details like selection, use, calibration, checking,
controlling, and maintenance of measurement standards, and reference standards for
measuring equipment.
6.5.2 XYZ ensures that measurement results are traceable to the International System of
Units (SI) through ensuring the followings:
a) calibration provided by a competent laboratory (ISO/IEC 17025 accredited calibration
laboratory);
b) certified values of certified reference materials provided by a competent producer (ISO
17034 accredited CRM producer or by committee) with stated metrological traceability
to the SI;
c) direct realization of the SI units ensured by comparison, directly or indirectly, with

national or international standards.
6.5.3 When metrological traceability to the SI units is not technically possible, XYZ
demonstrates metrological traceability to an appropriate reference, such as:
a) certified values of certified reference materials provided by a competent producer; or
b) results of reference measurement procedures, specified methods or consensus
standards that are clearly described and accepted as providing measurement results fit
for their intended use and ensured by suitable comparison.
Reference documents
QP/06 Procedure for measurement traceability and calibration
F/SYS/10 Calibration status of equipments
Page 27 of 59
Document No.
Issue No. 01
Date 01-08-2018
6.6 Externally provided products and services
6.6.1 XYZ ensures that only suitable externally provided products and services that affect
laboratory activities are used, when such products and services:
a) are intended for incorporation into the laboratory’s own activities, such as used in the
Testing/calibration of samples;
b) are provided, in part or in full, directly to the customer by the laboratory, as received
from the external provider;
c) are used to support the operation of the laboratory, such as equipments and
consumables, etc.
Products include measurement standards and equipment, auxiliary equipment, consumable
materials and reference materials. Services include, calibration services,
Testing/calibration services, facility and equipment maintenance services, proficiency
Testing/calibration services and assessment and auditing services taken from external
provider.
6.6.2 XYZ has implemented procedure (QP/07) for purchasing of externally provided
products and services and retain records for:
a) defining, reviewing and approving the requirements for externally provided products and
services;
b) defining the criteria for evaluation (F/PUR/04), selection, monitoring of performance and
re-evaluation (F/PUR/06) of the external providers;
c) ensuring that externally provided products and services conform to the XYZ’s
established requirements, or when applicable, to the relevant requirements of ISO/IEC
17025, before they are used or directly provided to the customer;
d) taking any actions arising from evaluations, monitoring of performance and re -

evaluations of the external providers.
6.6.3 XYZ communicates its requirements to external providers, for:
a) the products and services to be provided;
b) the acceptance criteria;
c) competence, including any required qualification of personnel;
d) activities that the laboratory, or its customer, intends to perform at the external
provider's premises.
All the above details are incorporated in the Purchase Order (F/PUR/01) and then the
purchase order is approved by Technical Manager before its issue to Approved External
Provider. Products and services are procured only from the external provider included in
the Approved External Provider List (F/PUR/03).
Page 28 of 59
Document No.
Issue No. 01
Date 01-08-2018
Reference documents
QP/07 Procedure for procurement of externally provided products and services
F/PUR/01 Purchase Order
F/PUR/02 Indent (Purchase requisition)
F/PUR/03 Approved External Provider List
F/PUR/04 Supplier Registration Form
F/PUR/05 Open Purchase Order
F/PUR/06 Supplier Evaluation Report
F/QCD/06 Inspection Report
Page 29 of 59
Document No.
Issue No. 01
Date 01-08-2018
7 Process requirements
7.1 Review of requests, tenders and contracts
7.1.1 XYZ has procedure (QP/08) for the review of requests, tenders and contracts. The
procedure ensures that:
a) the requirements related to Testing/calibration are adequately defined,
documented and
understood, and are referred in Sample test request slip (F/QCD/02).;
b) the XYZ has the capability and resources to meet the requirements, including the
requirements of test methods to be followed, such as Indian Standards / International
Standard;
c) no external providers are used (at present, subcontracting for Testing/calibration is not
done by
XYZ, hence, the requirements of this clause is not applicable);
d) The appropriate test methods are selected and are capable of meeting the customers’
requirements, which are based on Indian Standards / International Standards.
7.1.2 Customer will be immediately informed by XYZ, when the method requested by the
customer is considered to be inappropriate or out of date.
7.1.3 When the customer requests a statement of conformity to a specification or standard for the
test (e.g. pass / fail, complies / does not complies, in tolerance / out of tolerance) the
specification or standard, and the decision are clearly defined in the Sample test request
slip (F/CSD/02). Unless inherent in the requested specification or standard, the decision
rule selected is communicated to, and agreed with, the customer. Records of such decision
are maintained in the Sample test request slip (F/CSD/02).
7.1.4 Records of acceptance of each contract are maintained in the contract made with the
customer, including details of sampling plan and procedure, where applicable, by XYZ. It is
ensured that the difference between the requirements and capabilities are resolved before
finalization of contract. Records of reviews, including any significant changes, are
maintained in contract / Sample test request slip (F/QCD/02). Records are also maintained
of pertinent discussions with a customer relating to the customer’s requirements or the
results of the work during the period of execution of the contract, if any. Sample test
request slip (F/QCD/02) is signed by customer or his representative and by Technical
Manager as an acceptance of contract. Deviations requested by the customer do not
impact the integrity of the laboratory or the validity of the results.
7.1.5 The customer will be informed immediately, in case of any deviation from the contract.
7.1.6 If a contract needs to be amended after work has commenced, the same contract review
process will be repeated as described above. In such cases, either amended Sample test
request slip (F/QCD/02) or amended contract is prepared and is signed by XYZ
representative and customer representative as an agreement of acceptance of amended
Testing/calibration work with all technical details. Details of amendments are
communicated to all
affected personnel.
7.1.7 XYZ cooperates with customers or their representatives in clarifying the customer's
request and in monitoring the XYZ’s performance in relation to the work performed. The
cooperation can include:
Page 30 of 59
Document No.
Issue No. 01
Date 01-08-2018
a) providing reasonable access to relevant areas of the laboratory to witness customer-
specific laboratory activities; it means witnessing the Testing/calibration performed for customer’s
sample;
b) method followed for preparation, and dispatch of items needed by the customer for
verification purposes.
7.1.8 Records of reviews, including any significant changes, are retained. Records are retained
of pertinent discussions with a customer relating to the customer's requirements or the
results of the laboratory activities in the Sample test request slip (F/QCD/02).
Reference documents
QP/08 Procedure for Review of requests, tenders and contracts
F/QCD/02 Sample test request slip
F/QCD/09 Inward Register
Page 31 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.1.1 XYZ uses appropriate methods and procedures for all laboratory activities (Testing/calibration work
carried-out for the materials covered under the scope of accreditation) and, where
appropriate, for evaluation of the measurement uncertainty as well as statistical techniques
for analysis of data. These also include handling, transport, storage, and preparation of
items to be tested.
7.2.1.2 All methods, procedures and supporting documentation, such as instructions, standards,
manuals and reference data relevant to the laboratory activities, are kept up-to-date and
are made readily available to personnel, where the laboratory activities are carried-out.
7.2.1.3 It is ensured that, the latest valid version of a method is used during the laboratory
activities, unless it is not appropriate or possible to do so. When necessary, the application
of the method is supplemented with additional details to ensure consistent application.
XYZ uses Indian Standards / International Standards or other recognized
specifications that contain sufficient and concise information on how to perform laboratory
activities. The copies of those standards are being issued to laboratory personnel for
conducting the laboratory activities. For smooth operation, additional documentation for
optional steps in the method or additional details are provided considering the equipment to
be used for the laboratory activities for maintaining accuracy in the laboratory activities.
Method prepared, documented and issued for implementation are having following
information as minimum:
a) Identification No.,
b) Scope of activity,
c) Description of item to be tested,
d) Parameters etc.,
e) Equipment requirements, including technical performance requirements,
f) Reference of standards / materials on which basis the method is prepared,
g) Sample preservation methods / condition,
h) Description of Test Method, including
I. Checks to be done before commencement of Testing/calibration
II. Method for recording observation / print-out from the equipment
III. Safety precautions to be taken before and during Testing/calibration
i) Criteria for “Conformance / Compliance or Non-conformance / Non-compliance” are
provided based on acceptance norms as agreed with customer.
j) Test Report preparation method
7.2.1.4 When the customer does not specify the method to be used, XYZ selects an
appropriate method (considering the product / material under the test and its test
parameters) from the scope of accreditation and informs the customer of the method
chosen. The details of method selected for the test is clearly identified in the Sample test
request slip (F/QCD/02). Methods published either in Indian Standards / International
Standard, or by reputable technical organizations, or in relevant scientific texts or
journals, or as specified by the manufacturer of the equipment is recommended.
Laboratory-developed or modified methods are not used in the laboratory activities
performed by XYZ.
Page 32 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.2.1.5 XYZ verifies that it can properly perform methods before introducing them by ensuring
that it can achieve the required performance. Record of the verification of method
performance is retained in terms of method verification report (F/QCD/14) and filled print-
out from the equipment. If the method is revised by the issuing body, verification is repeated
considering its impact on the accuracy of the test results.
7.2.1.6 When method development is required, this is planned activity and is assigned to
competent personnel equipped with adequate resources. As method development
proceeds, periodic review is carried-out to confirm that the needs of the customer are still
being fulfilled. Any modifications to the development plan is approved and authorized.
7.2.1.7 Deviations from methods for all laboratory activities occurs only if the deviation has been
documented, technically justified, authorized, and accepted by the customer. Customer
acceptance for the identified deviation is agreed in the Sample test request slip (F/QCD/02),
if any.
7.2.2 Validation of methods
7.2.2.1 XYZ validates non-standard methods, laboratory-developed methods and standard
methods used outside their intended scope or otherwise modified. The validation is as
extensive as is necessary to meet the needs of the given application or field of application.
Method validation includes procedures for handling and transportation of test items. The
techniques used for method validation can be one of, or a combination of, the following:
a) evaluation of bias and precision using reference standards or reference materials;
b) systematic assessment of the factors influencing the result;
c) Testing/calibration method robustness through variation of controlled parameters, such
as oven
temperature, volume delivered, etc.;
d) comparison of results achieved with other validated methods;
e) inter-laboratory comparisons;
f) evaluation of measurement uncertainty of the results based on an understanding of the
theoretical principles of the method and practical experience of the performance of the
sampling or test method.
7.2.2.2 After validation of methods, if changes are made to a validated method, the influence of
such changes is determined and where they are found to affect the original validation, a
new method validation is performed.
7.2.2.3 The performance characteristics of validated methods are assessed for the intended use,
relevant to the customers' needs and consistent with specified requirements. Performance
characteristics includes, but are not limited to, the measurement range, accuracy, the
measurement uncertainty of the results, limit of detection, limit of quantification, selectivity
of the method, linearity, repeatability or reproducibility, robustness against external
influences or cross-sensitivity against interference from the matrix of the sample or test
object, and bias.
7.2.2.4 XYZ retains the following records of validation:
a) the validation procedure (QP/09) used;
Page 33 of 59
Document No.
Issue No. 01
Date 01-08-2018
b) specification of the requirements;
c) determination of the performance characteristics of the method;
d) results obtained;
e) statement on the validity of the method, detailing its fitness for the intended use.
Reference documents
QP/09 Procedure for method verification and validation
F/QCD/14 Method verification report
F/QCD/15 Method validation report
Page 34 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.3 Sampling
XYZ is not doing sampling of samples. Samples are received from customer at our
mobile Testing/calibration laboratory and hence a requirement of this clause is not applicable.
Page 35 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.4 Handling of test items
7.4.1 XYZ has procedure (QP/10) for the transportation, receipt, handling, protection,
storage, retention, and disposal or return of test items, including all provisions necessary to
protect the integrity of the test item, and to protect the interests of the laboratory and the
customer. Precautions are taken to avoid deterioration, contamination, loss or damage to
the item during handling, transporting, storing / waiting, and preparation for
Testing/calibration. Handling instructions provided with the item are followed. All
employees are made aware regarding the requirements of handling of test items and any
special care, if any.
7.4.2 XYZ has a system for the unambiguous identification of test items. All samples upon
receipt are identified by inward number / test number and the same is in numeric digit in
continuation. The identification no. is retained while the item is under the responsibility of
the laboratory. All samples received for the Testing/calibration are retained for the period of
1 day after
completion of Testing/calibration. The system of identification of test item ensures that test
items will not be confused physically or when referred to in records or other documents.
7.4.3 Upon receipt of the test item, deviations from specified conditions are recorded. When there
is doubt about the suitability of an item for test, or when an item does not conform to the
description provided, the XYZ consults the customer for further instructions before
proceeding and records the results of this consultation. When the customer requires the
item to be tested acknowledging a deviation from specified conditions, XYZ include a
disclaimer in the report indicating which results may be affected by the deviation. Samples
are disposed off in such cases.
7.4.4 When items have to be stored or conditioned under specified environmental conditions,
these conditions are maintained, monitored and recorded.
The process followed for sample collection, sample handling and storage are well-defined,
and the sample quantity required for each Testing/calibration is also defined.
The sample is received in laboratory with Sample test request slip (F/QCD/02).
Sample is checked during receipt for:
a) Physical condition,
b) Sufficient quantity / volume of sample to ensure completion / adequacy of sample for
satisfactory completion of all tests,
c) Parameters to be tested.
Upon completion of retention period, the sample will be disposed off. The details of samples
disposed and date of disposal is recorded in the inward register (F/QCD/09).
Reference documents
Procedure for transportation, receipt, handling, protection, storage, retention,
QP/10
and disposal or return of test items
E/SYS/06 Sample receipt checklist
F/QCD/09 Inward Register
Page 36 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.5 Technical records
7.5.1 XYZ ensures that technical records for each laboratory activity contain the results,
report and sufficient information to facilitate, if possible, identification of factors affecting the
measurement result and its associated measurement uncertainty and enable the repetition
of the laboratory activity under conditions as close as possible to the original. The technical
record includes the date and the identity of personnel responsible for each laboratory
activity and for checking data and results. Original observations, data and calculations are
recorded at the time they are made in the relevant records and are identifiable with the
specific task. The record includes the identity of personnel responsible for the performance
of each Testing/calibration and checking of results.
7.5.2 XYZ ensures that amendments to technical records can be tracked to previous versions
or to original observations. Both the original and amended data and files are kept, including
the date of alteration, an indication of the altered aspects and the personnel responsible for
the alterations. When mistakes occur in records, each mistake is crossed-out and not
erased, made illegible or deleted, and the correct value is entered alongside. All such
alterations to records are signed or initiated by the person making the correction. In the
case of records stored electronically, possible care is taken to prevent loss or change in the
original data. Any alteration made in computer / electronic media are identified with
amended copy. Original one is also maintained.
Reference documents
============ Print of results as an output from Testing/calibration machine
Work sheet - Raw DEF
Page 37 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.6 Evaluation of measurement uncertainty
7.6.1 XYZ has identified the contributions to measurement uncertainty. When evaluating
measurement uncertainty all contributions, which are of significance, including those arising
from sampling / filling, are taken into account using appropriate methods of analysis.
7.6.2 Being a Testing/calibration laboratory, the requirements of this clause is not applicable.
7.6.3 XYZ performs Testing/calibration and evaluates measurement uncertainty. Where the test method
precludes rigorous evaluation of measurement uncertainty (F/QCD/04), estimation is made
based on an understanding of the theoretical principles or practical experience of the
performance of the method. In some cases, well-recognized test method specifies limits to
the values of the major sources of measurement uncertainty and specifies the form of
presentation of the calculated results, XYZ is considered to have satisfied by following the
test method and reporting instructions.
XYZ has documented procedure QP/11 for estimating uncertainty of measurement. The
components for estimation of uncertainty are identified and included in the nature of test
method, which precludes rigorous, metrological, and statistically valid calculation. The form
(F/QCD/04) of reporting of results is clear and it does not give any wrong impression of the
uncertainty. The estimation of uncertainty is based on knowledge of the performance of the
method and on the measurement scope, including previous experience and validation data.
All such uncertainty calculations are done based on the guidelines given in ISO Guide 98-
3.
For a particular method where the measurement uncertainty of the results has been
established and verified, there is no need to evaluate measurement uncertainty for each
result, if the laboratory can demonstrate that the identified critical influencing factors are
under control.
Reference documents
Procedure for evaluation of measurement uncertainty and statistical techniques for
QP/11
analysis of data
F/QCD/04 Uncertainty of measurement calculation sheet
Page 38 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.7 Ensuring the validity of results
7.7.1 XYZ has a procedure (QP/12) for monitoring the validity of results. The resulting data
are recorded in such a way that trends are detectable and, where practicable, statistical
techniques are applied to review the results. This monitoring is planned and reviewed and
includes, where appropriate, but not limited to:
a) use of reference materials or quality control materials;
b) functional check(s) of measuring and Testing/calibration equipment prior to starting
the test by
comparing with the known value materials;
c) use of check or working standards with control charts, where applicable;
d) intermediate checks on measuring equipment, such as weighing balance etc.;
e) replicate tests using the same or different methods;
f) re-Testing/calibration of retained items;
g) correlation of results for different characteristics of an item;
h) review of reported results;
i) intra-laboratory comparisons;
j) Testing/calibration of blind sample.
7.7.2 XYZ monitors its performance by comparison with results of other laboratories, where
available and appropriate. This monitoring is planned (Four-year plan (F/QCD/01) is
prepared) and reviewed and include, but not limited to a selection from the following list:
a) participation in proficiency Testing/calibration (it is ensured that the PT Provider must
have ISO/IEC
17043 accreditation);
b) participation in inter-laboratory comparisons other than proficiency
Testing/calibration, through
accredited Testing/calibration laboratories in the similar materials and its parameters.
7.7.3 Data obtained from above monitoring activities are analyzed and used to control, and if
applicable, improve the laboratory's activities. If the results of the analysis of data from
monitoring activities are found to be outside pre-defined criteria, appropriate actions are
taken to prevent incorrect results from being reported. The pre-defined criteria for the
monitoring are as below:
Type of internal quality checks Acceptance criteria
Self-initiated Inter-Laboratory
Z Score between ± 2.0 (Means -2.0 to 2.0)
Comparison
Difference between the results must fall
For re-test / replicate test / intra-
between the acceptance criteria given in
laboratory comparison
E/SYS/08
Page 39 of 59
Document No.
Issue No. 01
Date 01-08-2018
Reference documents
QP/12 Procedure for ensuring and monitoring of validity of result
E/SYS/08 Acceptance criteria for internal quality checks
F/QCD/01 Four-Year Plan for Quality Control
F/QCD/03 ILC Analysis Report
F/QCD/05 Re-test analysis report
Page 40 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.8 Reporting of results
7.8.1 General
7.8.1.1 The results of test are reviewed and authorized prior to release.
7.8.1.2 The results are provided accurately, clearly, unambiguously and objectively, usually in a
report (e.g. test report), and include all the information agreed with the customer and
necessary for the interpretation of the results and all information required by the method
used. All issued reports are retained as technical records.
For the purpose of ISO/IEC 17025, test reports are sometimes called test certificates.
XYZ issues test report in the form of hard copy only. For HVI and ICC mode
Testing/calibration of DEF, the test report is directly generated from the HVI Machine. After
that the same is authorized by authorized personnel and then uploaded on the web site. For
raw DEF, the test certificate is prepared in computer and then print of test certificate is
taken, after authorizing the test certificate the same is scanned and uploaded on the
web site. Customer can enter with their login details and they can view the test report in
PDF format and can take print. All such process is followed in the non-editable format and
hence there are no chances of changes later on by user or anyone else.
7.8.1.3 When agreed with the customer, the results may be reported in a simplified way. Any
information listed in 7.8.2 to 7.8.7 which is not reported to the customer is made readily
available, when the simplified report is issued.
7.8.2 Common requirements for reports (test)
7.8.2.1 Each test report includes at least the following information, unless the XYZ has valid
reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse:
a) a title (e.g. “Test Report”);
b) the name and address of the XYZ in detail including the mobile lab vehicle
registration number;
c) the location of performance of the laboratory activities (Such as Mobile Testing/calibration
identification by identifying the vehicle number),
d) unique identification that all its components are recognized as a portion of a complete
report and a clear identification of the end;
e) the name and contact information of the customer;
f) identification of the test method used in the Testing/calibration of each parameter of
product /
material;
g) a description, unambiguous identification, and, when necessary, the condition of the
item during receipt;
h) the date of receipt of the test item(s),
i) the date(s) of performance of the laboratory activity;
j) the date of issue of the report;
k) a statement to the effect that the results relate only to the items tested,
l) the results with, where appropriate, the units of measurement;
m) additions to, deviations, or exclusions from the method;
n) identification of the person(s) authorizing the report; and
o) proprietary of test report, such as "the report shall not be reproduced except in full,
without approval of the laboratory".
Page 41 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.8.2.2 XYZ is responsible for all the information provided in the report, except when
information is provided by the customer. Data provided by a customer are clearly identified.
In addition, a disclaimer is addressed on the report when the information is supplied by the
customer and can affect the validity of results.
7.8.3 Specific requirements for the test reports
7.8.3.1 In addition to the requirements listed in 7.8.2, if specifically asked by the customer, the test
results include the following details:
a) information on specific test conditions (Temperature and humidity maintained during the
Testing/calibration), such as environmental conditions maintained during the Testing/calibration considering the
requirements of test standard;
b) where relevant, a statement of conformity with requirements or specifications, if

specifically asked by customer;
c) where applicable, the measurement uncertainty presented in the same unit as that of
the measurand or in a term relative to the measurand (e.g. percent) when:
it is relevant to the validity or application of the test results;
a customer's instruction so requires, or
the measurement uncertainty affects conformity to a specification limit;
d) where appropriate, opinions and interpretations;
e) additional information which may be required by specific methods, authorities,
customers or groups of customers.
7.8.3.2 As sampling is not done, hence requirement of this clause is not applicable.
7.8.4 Specific requirements for the calibration certificates
Being a Testing/calibration laboratory, the requirements given in the clause no. 7.8.4 and its sub-
clauses are not applicable.
7.8.5 Reporting sampling - specific requirements
As sampling is not done, hence requirement of this clause is not applicable.
7.8.6 Reporting statements of conformity
7.8.6.1 When a statement of conformity to a specification or standard is provided, XYZ
document the decision rule employed, taking into account the level of risk (such as false
accept and false reject and statistical assumptions) associated with the decision rule
employed and apply the decision rule. In such case Technical Manager Review the risk
register and the results of uncertainty of measurement is also considered in making the
decision rule as well as ensure that same decision rule which is agreed at contract review
stage is applied and such statement is made. Where the decision rule is prescribed by the
customer, regulations or normative documents, a further consideration of the level of risk is
not necessary.
7.8.6.2 XYZ reports on the statement of conformity (based on customer request) such that the
statement clearly identifies:
a) to which results the statement of conformity applies;
b) which specifications, standards or parts thereof are met or not met; and
c) the decision rule applied
Page 42 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.8.7 Reporting opinions and interpretations
7.8.7.1 When opinions and interpretations are expressed, XYZ ensures that only Technical
Manager, who is authorized for the expression of opinions and interpretations, releases the
respective statement. XYZ documents the basis upon which the opinions and
interpretations have been made. This interpretation and opinion are drawn based on
reference Indian Standards / International Standards and customer specification.
Such opinion and interpretation are clearly marked in a test report.
7.8.7.2 The opinions and interpretations expressed in reports are based on the results obtained
from the tested item and are clearly identified as such.
7.8.7.3 When opinions and interpretations are directly communicated by dialogue with the
customer, a record of the dialogue is retained by mentioning the details for the same in the
Sample test request slip (F/QCD/02).
7.8.8 Amendments to reports
7.8.8.1 When an issued report needs to be changed, amended or re-issued, any change of
information is clearly identified and, where appropriate, the reason for the change is
included in the report.
7.8.8.2 Amendments to a report after issue is made only in the form of a further document, or data
transfer, by following method:
a) Title is identified as “Test Report- Amended”
b) Date of issue is changed considering amendment issue date
c) Certificate no. is kept same
d) Reason for amendment alongwith the date of original issue of certificate.
e) Details of original report, such as original issue date of the same test report is clearly
identified in the Amended test report.
7.8.8.3 When it is necessary to issue a complete new report, this is uniquely identified and contains
a reference to the original that it replaces.
Reference documents
========= Test report
Page 43 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.9 Complaints
7.9.1 XYZ has a documented process (QP/13) to receive, evaluate and make decisions on
complaints.
7.9.2 A description of the handling process for complaints is available to any interested party on
request. Upon receipt of a complaint, XYZ confirms whether the complaint relates to
laboratory activities that it is responsible for and, if so, deals with it. XYZ is responsible
for all decisions at all levels of the handling process for complaints. The complaint is
recorded and the complain report (F/QCD/12) is prepared for its further investigation.
7.9.3 The process for handling complaints includes at least the following elements and methods:
a) description of the process for receiving, validating, investigating the complaint, and
deciding what actions are to be taken in response to it;
b) tracking and recording complaints, including actions undertaken to resolve them;
c) ensuring that any appropriate action is taken.
7.9.4 XYZ, on receiving the complaint, is responsible for gathering and verifying all necessary
information to validate the complaint.
7.9.5 Quality Manager acknowledges receipt of the complaint, and provides the complainant
with progress reports and the outcome through e-mail.
7.9.6 The outcomes communicated to the complainant is made by, or reviewed and approved by
Quality Manager / Technical Manager not involved in the original laboratory activities in
question.
7.9.7 Whenever possible, the laboratory gives formal notice of the end of the complaint handling
to the complainant.
Reference documents
QP/13 Procedure to receive, evaluate and make decisions on complaints
F/QCD/12 Complain report
Page 44 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.10 Non-conforming work
7.10.1 XYZ has documented and implemented procedure (QP/14) when any aspect of its
laboratory activities or results of this work do not conform to its own procedures or the
agreed requirements of the customer (e.g. equipment or environmental conditions are out
of specified limits, results of monitoring fail to meet specified criteria). The procedure
(QP/14) ensures that:
a) Technical Manager is responsible and authorized for the management of
nonconforming work once defined;
b) actions (including halting or repeating of work and withholding of reports, as necessary)
are based upon the risk levels established by the laboratory;
c) an evaluation is made of the significance of the nonconforming work, including an
impact analysis on previous results;
d) a decision is taken on the acceptability of the nonconforming work;
e) where necessary, the customer is notified and work is recalled;
f) Technical Manager is authorized for resumption of defined work.
7.10.2 Records of nonconforming work and actions taken on it as specified in 7.10.1, b) to f) is
maintained and retained in the Disposal of non-conforming work (F/QCD/13).
7.10.3 Where the evaluation indicates that the nonconforming work could recur or that there is
doubt about the conformity of the laboratory's operations with its own management system,
the laboratory implements corrective action against the nonconforming work.
Reference documents
QP/14 Procedure for control of nonconforming work
F/QCD/13 Disposal of non-conforming work
Page 45 of 59
Document No.
Issue No. 01
Date 01-08-2018
7.11 Control of data - Information management
7.11.1 XYZ has access to the data and information needed to perform laboratory activities in
terms of Testing/calibration of products / materials.
7.11.2 The laboratory information management system(s) used for the collection, processing,
recording, reporting, storage or retrieval of data are validated for functionality, including the
proper functioning of interfaces within the laboratory information management system(s) by
the XYZ before introduction. Whenever there are any changes, including laboratory
software configuration or modifications to commercial off-the-shelf software, they are
authorized, documented and validated before implementation.
7.11.3 The laboratory information management system(s) are:
a) protected from unauthorized access, computers used in maintaining laboratory activities
data are controlled by password protection;
b) safeguarded against tampering and loss;
c) operated in an environment that complies with supplier or laboratory specifications or, in
the case of non-computerized systems, provides conditions which safeguard the
accuracy of manual recording and transcription of data;
d) maintained in a manner that ensures the integrity of the data and information; and
e) includes recording system failures and the appropriate immediate and corrective
actions.
7.11.4 When laboratory information management system(s) are managed and maintained off-site
or through an external provider, XYZ ensures that the provider or operator of the
system(s) complies with all applicable requirements of ISO/IEC 17025.
7.11.5 XYZ ensures that instructions, manuals and reference data relevant to the laboratory
information management system(s) are made readily available to personnel.
7.11.6 Calculations and data transfers are checked in an appropriate and systematic manner to
ensure validity of data and its transfer. Procedure (QP/15) is implemented for control of
data and its transfer.
Reference documents
QP/15 Procedure for control of data
Page 46 of 59
Document No.
Issue No. 01
Date 01-08-2018
8 Management system requirements
8.1 Options
8.1.1 General
XYZ has established, documented, implemented and maintained a management
system that is capable of supporting and demonstrating the consistent achievement of the
requirements of ISO/IEC 17025 and ensuring the quality of the laboratory results. In
addition to meeting the requirements of clauses 4 to 7 of ISO/IEC 17025, XYZ has
implemented a management system in accordance with option A.
8.1.2 Option A
As a minimum, the management system of the laboratory addresses the following as a part
of management system requirements:
management system documentation (as per 8.2)
control of management system documents (as per 8.3)
control of records (as per 8.4)
actions to address risks and opportunities (as per 8.5)
improvement (as per 8.6)
corrective action (as per 8.7)
internal audits (as per 8.8)
management reviews (as per 8.9)
8.1.3 Option B
XYZ has implemented the requirements of Option A, and hence, requirements of this
clause are not applicable.
8.2 Management system documentation (Option A)
8.2.1 XYZ has established, documented, and maintained policies and objectives for the
fulfillment of the purpose of ISO/IEC 17025 and ensures that the policies and objectives are
acknowledged and implemented at all levels of the laboratory organization. The detailed
Quality Policy is given as below:
8.2.2 The policies and objectives address the competence, impartiality and consistent operation
of the laboratory.
8.2.3 XYZ provides evidence of commitment to the development and implementation of the
management system and to continually improving its effectiveness.
Page 47 of 59
Document No.
Issue No. 01
Date 01-08-2018
Indian DEF Solutions.com Pvt. Ltd.

Quality Policy
XYZ is committed to achieve total customer satisfaction for the Testing/calibration services
that we
offer.
XYZ will achieve this by:
a.) Establishing good professional practices and providing quality services to customers,
b.) Maintaining accuracy, precision, and reliability of Testing/calibration services through maintaining
standards,
c.) Maintaining competence, impartiality and consistent operation of laboratory activities,
d.) Adoption and maintenance of an laboratory management system for our laboratory
Testing/calibration
activities in accordance with ISO/IEC 17025,
e.) Encouraging and welcoming customer feedback to proactively improve our performance and
quality of services,
f.) Familiarizing all employees with relevant documents,
g.) Complying with ISO/IEC 17025 and continually improving the effectiveness1of st
August 2018
the management
ABCD- CEO
system through regular review.
Quality Objectives
Mistake in the report identified during the review 1 Max. / Quarter
Customer complaint related to Testing/calibration service provided to them 1 Max. / Quarter
Customer satisfaction level achievement 90 % Min.
8.2.4 All documentation, processes, systems, and records related to the fulfillment of the
requirements of ISO/IEC 17025 are included in, referenced from, or linked to the
management system. The hierarchy of documentation prepared, implemented and cross-
referred in the lab are as under;
Tier Name of Documents Cross-referred in
1st Quality Manual =======
2nd Quality Procedure Quality Manual
3rd Work Instructions / Test Methods Quality Procedures
Quality Manual, Quality Procedures and
4th Formats
Work Instructions / Test Methods
8.2.5 All personnel involved in laboratory activities have access to the relevant parts of the
management system documentation and related information that are applicable to their
responsibilities.
Reference documents
F/SYS/05 Quality objective monitoring report
Page 48 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.3 Control of management system documents (Option A)
8.3.1 XYZ controls the documents (internal and external) that relate to the fulfillment of
ISO/IEC 17025. XYZ has established and maintained procedure (QP/16) to control all
documents that have formed part of management system, such as regulations, standards,
other normative references, test methods, specifications, instructions, manuals and others
used as references are covered in the document control system.
All documents prepared by the XYZ to fulfill the requirements
Internal documents
of ISO/IEC 17025 as well as other reference standards.
Customer documents Indian Standard
External documents Supplier documents International Standard
Manufacturer’s manual Testing/calibration guidelines
8.3.2 XYZ ensure that:

a) All documents issued to personnel in the laboratory as part of the management system
are reviewed and approved for use by authorized personnel prior to issue as per the
details given below. A master list and distribution list of documents (F/SYS/01) is
maintained for all tiers of documents, showing current revision status and distribution of
documents.
Responsibility Matrix For Documents

Authority to
Maintaining
Type of document Master list and
Prepare Review Approve Issue
issuing as per
distribution
Quality Quality
1. Quality manual CEO CEO Quality Manager
Manager Manager
Quality Quality
2. Quality procedure CEO CEO Quality Manager
Manager Manager
3. Applicable reference Quality
===== ===== ===== Quality Manager
standards (external) Manager
4. Formats, work
instructions Quality Quality
CEO CEO Quality Manager
5. Exhibits, reference Manager Manager
documents and data
6. Customer
specifications, and Quality
===== Quality Manager ===== Quality Manager
documents of Manager
external origin
b) All documents (such as Quality Manual, Quality Procedures, Work Instructions /
Test Methods, Formats, etc.) are reviewed every year (mainly during management
review meeting) and, where necessary, are revised to ensure continuing suitability and
compliance with applicable requirements to ensure its compliance with laboratory’s
current practices; documented information are retained for such periodic review of
documents in the F/SYS/16.
Page 49 of 59
Document No.
Issue No. 01
Date 01-08-2018
c) Changes / amendments done in any documents are identified; such latest changes are
identified by putting asterisk (*) or suitable marking on right or left hand of particular text
/ paragraph affected along with the underlining of the affected text / paragraph etc. Such
marking indicates the latest changes and all personnel of laboratory are acquainted of
the same. Changes are supported by change note (F/SYS/02), which is maintained by
Quality Manager.
d) Relevant versions of applicable documents are available at points of use and, where
necessary, their distribution is controlled; details of distribution of documents are
controlled, and are maintained by Quality Manager.
e) Documents are uniquely identified, as per the numbering system described in the next
table.
f) Invalid or obsolete documents are promptly removed from all points of issue or use, or
otherwise assured against unintended use by putting stamp of “Obsolete Copy” on
such documents. Obsolete documents are retained for legal or knowledge preservation
purposes marked as “Obsolete Copy” and are maintained with Quality Manager for
three years.
Reference documents
QP/16 Procedure for document and data control
F/SYS/01 Master list and distribution list of documents
F/SYS/02 Change Note
F/SYS/16 Periodic document review report
Page 50 of 59
Document No.
Issue No. 01
Date 01-08-2018
All documents are identified by unique document numbering system as per the details given
below:
Numbering System for Documents
Numbering System for Quality Procedure
QP/XX
A.
QP Quality Procedure
XX Stands for continuous sl. no. of procedure
Numbering System for Work Instruction or Standard Operating Procedure
W/AAA/XX or SOP/AAA/XX
W Work instruction
B.
SOP Standard Operating Procedure
AAA Stands for 3-digit department code as per E/SYS/01
XX Stands for continuous sl. no. of work instruction or standard operating procedure
Numbering System for Exhibit
E/AAA/XX
C. E Exhibit
XX Stands for continuous sl. no. of exhibit
Numbering System for Formats
F/AAA/XX
D. F Formats
XX Stands for continuous sl. no. of format
Page 51 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.4 Control of records (Option A)
8.4.1 XYZ has established and retained legible records to demonstrate fulfillment of the
requirements of ISO/IEC 17025.
8.4.2 XYZ has established and maintained procedure for control of records (QP/17)
considering identification, collection, indexing, access, filing, storage, protection, back -up
archive, retrieval, retention time, maintenance, and disposal of quality and technical
records. Quality records also include reports from internal audits and management reviews
as well as records of corrective actions, etc. XYZ retains records for a period consistent
with its contractual and legal obligations. Access to these records is consistent with the
confidentiality commitments and records are made readily available. The procedure also
covers the details of protection and back-up of records stored electronically and to prevent
unauthorized access to or amendment of these records. All records maintained in computer
are safeguarded from virus, having password protection and back-up of all such data /
records are taken on monthly basis by users. Retention times of records are established
and recorded in the Master List of Records (F/SYS/04). Master list of records with their
retention period is also included at the end of this clause.
Reference documents
QP/17 Procedure for control of records
F/SYS/04 Master List of Records
Page 52 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.5 Actions to address risks and opportunities (Option A)
8.5.1 XYZ has considered the risks and opportunities associated with the laboratory activities
in order to:
a) give assurance that the management system achieves its intended results;
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
and
d) achieve improvement.
8.5.2 XYZ has planned:
a) actions to address these risks and opportunities;
b) how to:
integrate and implement the actions into its management system;
evaluate the effectiveness of these actions.
8.5.3 Actions are taken to address risks and opportunities. It is ensured that the same are
proportional to the potential impact on the validity of laboratory results. Risk and
opportunities related to laboratory activities are identified and are implemented in the Risk
assessment sheet (F/SYS/09). Procedure (QP/18) is prepared for the Risk assessment.
Risk assessment sheet is prepared and is reviewed annually during the management
review meeting.
Reference documents
QP/18 Procedure for Risk assessment
F/SYS/09 Risk assessment sheet
Page 53 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.6 Improvement (Option A)
8.6.1 XYZ has identified and selected opportunities for improvement and implemented
necessary actions for the improvement in the laboratory activities. Opportunities for
improvement are identified through:
review of the operational procedures,
the use of the policies,
overall objectives,
audit results,
corrective actions,
management review,
suggestions from personnel,
risk assessment,
analysis of data, and
proficiency Testing/calibration results.
Improvement log is maintained as soon as it is identified.
8.6.2 After providing the Testing/calibration services to the customer, the customer feedback form
(F/QCD/11) is submitted to customer alongwith the test report for taking feedback, both
positive and negative, from customer related to service provided. Quality Manager follows-
up with the customer for the collection of filled customer feedback form in time. Upon
receipt of customer feedback form, the same is reviewed for the comments given by
customer. If the feedback given by customer is Average or Poor, then customer is
communicated about such ranking and necessary actions are initiated by the Quality
Manager, based on customer’s comments. Also, actions initiated for the same are informed
to the customers. Every year, customer feedback is analyzed and percentage satisfaction
level of customer is identified.
Reference documents
F/SYS/15 Improvement log
F/QCD/11 Customer Feedback Form
Page 54 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.7 Corrective action (Option A)
8.7.1 Procedure (QP/19) is documented and implemented for the corrective action. When a
nonconformity occurs, the XYZ:
a) reacts to the nonconformity and, the nonconformity is reported in the non-conforming
work (F/QCD/13):
immediate action is taken to control and correct the nonconformity. As a policy
decision, all employees have been informed to stop the work immediately as soon
as nonconformity is identified;
the consequences of nonconformity are addressed and then appropriate actions are
taken;
b) conducts further root cause analysis to evaluate the need for action to eliminate the
cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
reviewing and analysing the nonconformity;
determining the causes of the nonconformity;
determining if similar nonconformities exist, or could potentially occur;
c) implements identified corrective action (F/SYS/03) needed to prevent recurrence of the
nonconformity;
d) reviews the effectiveness of any corrective action taken after defined implementation
period to ensure that the corrective action taken is effective and similar types of
nonconformity is not repeated after implementation of corrective action;
e) updates risks and opportunities determined during planning, if necessary;

f) makes changes to the management system documentation based on the corrective
action, if necessary.
8.7.2 Corrective actions are initiated / taken appropriate to the effects of the nonconformities
encountered.
8.7.3 The laboratory retains records as evidence of:
a) the nature of the nonconformities, cause(s) and any subsequent actions taken;
b) the results of any corrective actions.
Reference documents
QP/19 Procedure for corrective action
F/SYS/03 Corrective action report
Page 55 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.8 Internal audits (Option A)
8.8.1 XYZ has documented and implemented procedure (QP/20) for internal audit. XYZ
conducts internal audit at least once in six months to provide information on whether the
management system:
a) conforms to:
the laboratory’s own requirements for its management system, including the
laboratory activities;
the requirements of ISO/IEC 17025;
b) is effectively implemented and maintained within the laboratory.
8.8.2 XYZ:
a) plans, establishes, implements and maintains an audit program (F/SYS/06), including
the frequency, methods, responsibilities, planning requirements and reporting, which
takes into consideration the importance of the laboratory activities concerned, changes
affecting the laboratory, and the results of previous audits;
b) defines the audit criteria and scope for each audit, and addresses them in the audit plan
/ schedule (F/SYS/06);
c) ensures that the results of the audits, in terms of audit findings and internal audit non-
conformity report (F/SYS/07), are reported to relevant management;
d) implements appropriate correction and corrective actions without undue delay and
retains documented information in the form of internal audit non-conformity report
(F/SYS/07);
e) retains records as evidence of the implementation of the audit programme (F/SYS/06)

and the audit results (F/SYS/07).
Reference documents
QP/20 Procedure for internal audit
F/SYS/06 Audit Plan / Schedule
F/SYS/07 Internal Audit Non-Conformity Report
F/SYS/08 Clause-wise document-wise audit review report
F/SYS/11 Clause-wise audit report - Management requirements
F/SYS/12 Clause-wise audit report - Technical requirements
Page 56 of 59
Document No.
Issue No. 01
Date 01-08-2018
8.9 Management reviews (Option A)
8.9.1 The Top Management reviews management system at least once in six months, in order
to ensure its continuing suitability, adequacy and effectiveness, including the stated policies
and objectives related to the fulfillment of ISO/IEC 17025 requirements. Procedure (QP/21)
is documented and implemented for planning and conducting management review meeting.
8.9.2 The inputs to management review (Circular - called as MRM Agenda, F/SYS/13) are
defined and recorded, and include information related to the following:
a) changes in internal and external issues that are relevant to the laboratory;
b) fulfillment of objectives;
c) suitability of policies and procedures;
d) status of actions from previous management reviews;
e) outcome of recent internal audits;
f) corrective actions;
g) assessments by external bodies;
h) changes in the volume and type of the work or in the range of laboratory activities;
i) customer and personnel feedback;
j) complaints;
k) effectiveness of any implemented improvements;
l) adequacy of resources;
m) results of risk identification;
n) outcomes of the assurance of the validity of results; and
o) other relevant factors, such as monitoring activities and training.
8.9.3 During the management review meeting, Quality Manager records the outputs from the
management review in terms of decisions and actions related to at least:
a) the effectiveness of the management system and its processes;
b) improvement of the laboratory activities related to the fulfillment of the requirements of
this document;
c) provision of required resources;
d) any need for change.
Detailed minutes of meeting are prepared by Quality Manager along with the review
meeting output and are approved by the Top Management. Minutes of meeting is circulated
to all concerned for taking timely actions on it as per the action plan. Quality Manager
keeps track of the action plan and ensures that the actions are taken in a timely manner.
Reference documents
QP/21 Procedure for management review meeting
F/SYS/13 Circular - MRM Agenda
F/SYS/14 Minutes of management review meeting
Page 57 of 59
Document No.
Issue No. 01
Date 01-08-2018
Annexure - 1 List of documents

Quality Procedures
Sr. ISO/IEC 17025 Quality Procedure
Title of Procedure - Procedure For
No. Clause Number Number
1. 4.1 Maintaining impartiality of laboratory activities QP/01
2. 6.2 Personnel and training QP/02
3. 6.3 Maintain laboratory environmental condition QP/03
Handling, transport, storage, use and planned
4. 6.4 QP/04
maintenance of equipment
5. 6.4 Intermediate checks QP/05
6. 6.5 Measurement traceability and calibration QP/06
Procurement of externally provided products and
7. 6.6 QP/07
services
8. 7.1 Review of requests, tenders and contracts QP/08
9. 7.2 Method verification and validation QP/09
Transportation, receipt, handling, protection,
10. 7.4 storage, retention, and disposal or return of test QP/10
items
Evaluation of measurement uncertainty and
11. 7.2.1.1 / 7.6 QP/11
statistical techniques for analysis of data
12. 7.7 Ensuring and monitoring of validity of result QP/12
Receive, evaluate and make decisions on
13. 7.9 QP/13
complaints
14. 7.10 Control of non-conforming work QP/14
15. 7.11 Control of data QP/15
16. 8.3 Document and data control QP/16
17. 8.4 Control of records QP/17
18. 8.5 Risk assessment QP/18
19. 8.7 Corrective action QP/19
20. 8.8 Internal audit QP/20
21. 8.9 Management review QP/21
Page 58 of 59
Document No.
Issue No. 01
Date 01-08-2018
Technical Documents - Exhibits

Sr. ISO/IEC 17025 Document
Title of documents
No. Clause Number Number
22. 8.3 Codification system E/SYS/01
23. 6.5 Calibration periodicity E/SYS/02
24. 4.2 Secrecy rules E/SYS/03
25. 5.7 Communication process E/SYS/04
26. 4.1 Impartiality policy E/SYS/05
27. 7.4 Sample receipt checklist E/SYS/06
28. 5.3 Scope of accreditation E/SYS/07
29. 7.7 Acceptance criteria for internal quality checks E/SYS/08
30. 6.2 Skill requirements E/HRD/01
Technical Documents - Work Instructions
31. 6.4 and 7.2 Standard operating procedures SOP/OPN/XX
Page 59 of 59

Draft QM 17025 2017

Uploaded by

Copyright:

Available Formats

Draft QM 17025 2017

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Draft QM 17025 2017

Uploaded by

Copyright:

Available Formats

Document No.

Prepared By Approved By Issued By

Designation Quality Manager CEO Quality Manager

Prepared By Approved By Issued By

Amendment No. 00 Amendment Date == Copy No.

This Quality Manual is released under

Prepared By Approved By Issued By

Amendment No. 00 Amendment Date == Copy No.

Chapter 1.0 General Information

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

1.1 Table of contents

Prepared By Approved By Issued By

Amendment No. 00 Amendment Date == Copy No.

1.2 Amendment record sheet

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

1.3 Glossary Of Terms (Abbreviations)

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

Chapter 2.0 Authorization Statement and XYZ Profile

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

2.2 Company Profile

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

2.3 Context of organization

2.4 Testing/calibration facilities covered in ISO/IEC 17025:2017 Scope

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

3.0 Controls and Distribution

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

3.5 Distribution list of Quality Manual

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

Prepared By Approved By Issued By

Quality Manager CEO Quality Manager

CEO and Technical Manager

General Manager and Quality Manager

Mobile Laboratory Incharges

Mobile Laboratory Operators

Prepared By Approved By Issued By

Prepared By Approved By Issued By

Prepared By Approved By Issued By

b) the integrity of the management system is maintained when changes to the

Prepared By Approved By Issued By

Responsibility and authority of the Top Management (CEO)

Prepared By Approved By Issued By

Responsibility and authority of Quality Manager

Prepared By Approved By Issued By

Responsibility and authority of Technical Manager

Prepared By Approved By Issued By

Responsibility and authority of Testing/calibration personnel

Prepared By Approved By Issued By

Prepared By Approved By Issued By

Prepared By Approved By Issued By

Prepared By Approved By Issued By

Prepared By Approved By Issued By