ISO 15189

Introduction to Internal Auditing

 Definition of Audit

Systematic, independent and documented process for

obtaining audit evidence and evaluating it objectively to
determine the extent to which audit criteria are fulfilled.
ISO 19011:2002
 Few definitions (ISO 9000)

• Process: Set of interrelated or interacting activities which transform inputs in

to outputs

• System: Set of interrelated or interacting elements

• Management system: System to establish policy and objectives and to

achieve those objectives

• Quality management system: System to establish policy and objectives with

regard to quality and to direct and control an organization to achieve those
objectives
 Few definitions (ISO 9004)
• Process approach: Achieving desired results more efficiently
by managing activities and related resources as a process

• System approach to Management: Identifying,

understanding and managing interrelated processes as a
system that contribute to the organization’s effectiveness
and efficiency in achieving its objectives
 ISO 19011:2011
Guidelines for auditing Management systems

AUDIT TYPES
QUALIFIED AUDITORS
OBJECTIVES
RESPONSIBILITIES
 Types of audits
A. First party auditing- Audits carried out by a laboratory on it’s own
systems

B. Second party auditing- Audits carried out by one organization on

another prior to or after contract placement

C. Third party auditing- Audits carried out by independent accredited

organizations
 Audits evidence

Records, statement of fact or other information, which

are relevant to the audit criteria and verifiable.
ISO 19011:2022
 Objective evidence

EVIDENCE THAT EXISTS Factual evidence

AND IS
VERIFIABLE OBSERVATIONS
DOCUMENTED
STATEMENTS

Not Auditors opinion

 Audit criteria
Set of policies, procedures or requirements

note: audit criteria used as a reference against which audit

evidence is compared.
ISO 19011:2002
 Internal audits
PLANNED ON BASIS OF STATUS AND IMPORTANCE AND RESULTS OF
PREVIOUS AUDITS

INDEPENDENCE OF AUDITOR

REPORTING TO MANAGEMENT

CORRECTIVE ACTION WITHOUT

UNDUE DELAY
 Internal audits

Audit criteria, scope,

frequency and methods
shall be defined.
 Objectives of internal audits

• To identify the weaknesses in the system

• To provide opportunity for improvement
• To provide information about the QMS to the management
• To find and resolve non-compliances before the certification body or
customer finds them
 Principles of auditing
• Ethical conduct: Trust, integrity, confidentiality and discretion

• Fair presentation: Report truthfully and accurately

• Due professional care: Application of diligence and care

• Independence: Basis for impartiality of the audit and objectivity

• Evidence based approach: The rationale method for reaching reliable

and reproducible audit conclusions in a systematic manner
 Auditor

A person with the demonstrated

personal attributes
and competence to conduct the audit
ISO 9000:2005

And is authorized
Auditor personal attributes
ETHICAL
OPEN-MINDED
DIPLOMATIC
OBSERVANT
PERCEPTIVE
VERSATILE
TENACIOUS
DECISIVE
SELF-RELIANT
PROFESSIONAL

Familiar with quality management system

Auditor personal attributes
Negative characteristics
Poor at preparation and planning
Too rigid
Opinionated
Jumps to conclusion
Argumentative
Bad communicator
Easily influenced
Space in office
Poor time keeping
Afraid of passing unpopular judgements
 Audit team

• Lead auditor
• Audit team members
• Technical experts
• Observers
 Responsibilities- Lead auditor
• Manage audit team and process
• Assisting selection of audit team
• Prepare audit plan and checklist
• Liaison with auditee
• Coordinate and control the audit
• Prepare and audit report
 Responsibilities- Auditor
• Communicate and clarify requirements
• Execute audits
• Compliance with audit plan
• Record findings
• Report non-conformances
• Retain and safeguard audit documents
• Cooperate and support audit teams
 Responsibilities- Auditee
• Cooperate with auditor
• Provide all resources needed for the audit
• Provide access to facilities and evidence
• Provide guides
 Audit life cycle

Plan
Planning
Conducting
Analyzing
Corrective
Audit Reporting
actions
Corrective action
Follow-up
Evaluate
results
 P-D-C-A cycle

Plan Do

Action Check

Ref: SLS ISO 19011:2002- Guidelines for Quality and/or Environmental Management Systems auditing
 Authority for the audit program ---------------------------------------------------------------

Plan
Establishing the audit program
-Objectives and extent, Responsibilities
-Resources, procedures
------------------------------------------------------------------------------------
Action Implementing the audit program Competencies
-Scheduling audits & Evaluation Improving -
Evaluating auditors of auditors

D
o
the audit -Selecting audit teams
Program -Directing audit activities Audit activities
-Maintaining records
------------------------------------------------------------------------------------

Check
Monitoring & reviewing the audit program
Monitoring & reviewing
Identifying needs for corrective & preventive actions
Identifying opportunities for improvements -----------------------------------------------
Proper
Planning and
Preparation
Prevent
Poor
Performance
 Audit base
ISO
15189 Manual
Reqts. Procedures
etc Auditor’s
Checklist

Base Modified by
Criteria
 Auditor’s Task
INTERVIEWING

EXAMINATION VERIFICATION QUESTIONING

OBSERVATION

OBJECTIVE EVIDENCE
 What do we examine?
-DOCUMENTATION

-TOOLS/ EQUIPMENT

-REFERENCE STANDARDS

-PEOPLE

-CONSUMABLES
 Assessment process
Two stages

Stage 1: Assess documented system

Stage 2: Assess system implementation

 Control of the audit
It is the responsibility of the Lead Auditor
to exercise control over the Audit Process
at all times and to
ensure that the audit objectives are met
 Audit rules
PLANNING
AVOID SIDETRACKS
ALWAYS SEEK EVIDENCE
AGREE ON FACTS FOUND
CHANGE STYLE
DO NOT TAKE OFFENSE
DO NOT RISE TO AGGRESSION
DO NOT ARGUE
BE CONSTRUCTIVE
ALWAYS FOLLOW TRIALS

INNOCENT UNTIL PROVEN GUILTY!

 Audit records
Audit identity
Objectives and scope
Auditor details
Planning data
Checklists
Auditor’s notes
Conclusions
Non-conformities
Corrective action proposals
Corrective action verification

WILL BE EXAMINED BY THIRD PARTIES!

 Corrective action and audit close out
Non-conformity raised

Understanding

Analysis

Root cause determination

Corrective action Proposal Auditing organization

Implementation Follow up audit

Verification on gong surveillance

Process approach
 Process involved in Medical Testing key
processes
• Acceptance of patients
• Pre-examination processes
• Examination processes
• Advisory services
• Acquisition and maintenance of laboratory equipment
• Maintaining laboratory environment
• Purchase of services and supplies
• Delivery of test reports
• Sample collection, storage and transportation
• Training and competence building of personnel
 Process involved in Medical Testing key
processes contd…
• Examination by referral laboratories
• Handling of customer complaints and feedback
• Control of nonconformities
• Corrective action
• Preventive action
• Internal audits
• Management review and continual improvement
• Conducting quality assurance programs
• Post-examination processes
• Control of documents
• Control of records
 Process Mapping
Customer Acceptance of requests

Pre-examination

Advisory services
Lab equipment Sample collection, storage, Training and
transportation competency
Purchase of services

Laboratory Post-examination
and supplies

environment Examination Quality assurance Referral

laboratories Delivery of report

Customer
 Quality and process objectives
• Quality objectives
Increase reliability of test results
Developing competence of personnel
Reduction of customer complaints
Reduction of nonconforming reports

• Process objectives
Use of modern technology and equipment
Increase the no. of patients examined/ samples tested/ reports issued
Increase effectiveness and efficiency
Increase the no. of samples per laboratory staff
 Process Mapping
Customer Acceptance of requests (4.4)

Pre-examination (5.4)
services and supplies

(5.3)Lab equipment Sample collection, storage, (5.1)Training and

Advisory services (4.7)

(4.6)Purchase of

transportation (5.4) competency

(5.2)Laboratory Post-examination(5.7) environment

Examination(5.5) Quality assurance(5.8) Referral laboratories(4.5)
Delivery of report (5.9)

Customer
 Process availability matrix
ISO 15189 element P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11
4.1 Organization &management responsibility
4.2 Quality management system
4.3 Document control
4.4 Service agreements
4.5 Examination by referral laboratories
4.6 External services & supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification & control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Control of records
4.14 Evaluation & audits
4.15 Management reviews
5.1 Personnel
5.2 Accommodation & environmental conditions
5.3 Laboratory equipment, reagents &consumables
5.4 Pre-examination processes
5.5 Examination processes
5.6 Ensuring quality of examination results
5.7 Post examination processes
5.8 Reporting of results
5.9 release of results
5.10 Laboratory information management
 Inputs out puts mapping
Testing process
Quality policy
Inputs Outputs
Test requests(4.4) Tested samples(5.7)
Examination procedure(5.5) Testing process Test results (4.13)
Test samples (5.4) Testing(5.5) Non-conforming works(4.9)
Equipment(5.3) Working records (4.13)
Environmental conditions (5.2) Handling of test items (5.4 & 5.7) Retests (4.9)
Accommodation(5.2) Corrective actions(4.10)
Technical personnel(5.1) Preventive actions(4.11)
Supervision(5.1) Test reports(5.8)
Consumables(5.3)
Reference materials (5.3)
Control charts (5.6) Continual improvement (4.12)
 Audit planning
• List all the activities
• Determine the period you need to complete the audit
• Ensure that each activity is covered
Take the help of a check list
• Identify the persons to be used for auditing
• Ensure their availability and properly coordinate with individual(s) of the
section to be audited
• Decide to what extent sampling is to be done. Discuss it with individuals or lab
staff to be used for audit
• If negative findings are there, more sampling to be drawn to establish the fact
that these are isolated cases or otherwise
 Annual audit schedule
Elements/clause Jan Feb Mar Apr May
4.1 Organization and management
responsibility ͯ
4.2
4.3
ͯ

5.4 Pre-examination process

ͯ
ͯ

All elements shall be covered in one audit cycle – At least once a year
 Audit plan for a laboratory

(A simple audit plan for one or two auditors working together)

 Action plan for sampling
• Laboratory manager 5 mins - Entry
15 mins- Establish
responsibilities & intent
• Customer/Patients liaison officer 30 mins- Establish practice
• Analyst/MLT 15 mins- Verify
• Laboratory assistant 30 mins- Review process
• Analyst 15 mins- Verify
• Laboratory manger 10 mins- Exit
• Total time 120 mins
CHECK LISTS
 Check lists

GUIDE
Checklists
AIDE MEMORIE remind us of
the audit sample
CONTINUITY
 High level check list (Generic)
• Does the laboratory have space to work without compromising the quality
of work, quality control procedures, safety of personnel or patient care
services?

• Is laboratory designed for the efficiency of operation, to optimize the

comfort of occupants and to minimize the risk of injury and occupational
illness?

• Are environmental conditions monitored, controlled, and recorded?

• Are these effective separations between adjacent sections?

 Preparation of High level check list-
Specific
Requirements Policy Checklist
Laboratory shall Laboratory is Is laboratory provided
have space provided with with sufficient space to
allocated so that sufficient space to perform test?
its workload can produce correct
be performed and reliable Are accommodation &
without results, & to environmental
compromising the ensure safety of conditions described
quality of work, staff &patients for each test?
quality control
procedures, Does the space
safety of personnel or allocated affect the quality of work
patient care services quality control procedures, safety of
personnel or patient care services?
 High level check list (Specific)
YES/NO
• Is laboratory provided with sufficient space to 
perform tests?
Are accommodation & environmental conditions 
described for each test?
• Does the space allocated affect the quality of work? 
• Does the space allocated affect the quality control 
procedures?
• Does the space allocated affect the safety of personnel 
or patient care services?
 Low level (detail) check list
• Are the space conditions maintained in the laboratory?

• Are the environmental conditions maintained in the laboratory? Are they

documented? If so, where are they documented?

• Are mechanisms used to control the space for not affecting the quality of
work?

• Is it noticed when there is a deviation in the measured conditions? What

action is taken?
 Low level (detail) check list
• All those things that the auditor wishes to examine at the time of
audit, together with the number to be examined

AUDIT SAMPLE

Documents, records, tools, materials,

Products etc. To be examined
Types of audits

Vertical audit
Horizontal audit
Forward tracing
Backward tracing
Vertical audit examples
Horizontal audit examples
Forward tracing
Backward tracing
 Reporting

Nonconformities
Final Audit report(s)
 Final audit report(s)
Name of laboratory/section
Date(s) & elements covered
Auditors/elements audited
Auditee(s)
Summary of audit 5.1
5.2…..

Nonconformities Major Minor Observation

Recommendation/decision by audit team
Auditee’s acknowledgement Auditor’s acknowledgement
Auditor’s comment on corrective action/ follow up
THANK YOU!