ISO 15189 is an international standard that specifies the general requirements for the competence of medical laboratories. It is based on ISO 17025 for testing and calibration laboratories and ISO 9001 for quality management systems. ISO 15189 has both management and technical requirements that medical laboratories must meet in order to be accredited. The standard is designed to ensure that laboratories consistently deliver accurate, reliable and timely medical testing services.

1. Laboratory accreditation by
ISO 15189
Gift Ajay Sam
Lecturer/Quality Manager
Department of Transfusion Medicine and Immunohaematology
CMC, Vellore

2. What are international standards?
• Make things work
• Give international specification for products, services and systems
• Facilitate international trade
• Global standards facilitate recognition and exchange of services

3. What is ISO
• Independent non governmental organization with a membership of
162 national standard bodies
• 3types of membership
• Full member
• Correspondent member
• Subscriber
• Members are foremost standards organization in their countries, each
member represents ISO in their country
• Individuals and private companies cannot become members

4. BIS
• Bureau of Indian Standards formed by act of parliament on Nov 26,
1986
• Succeeded the ISI (Indian Standard Institution) that was primarily a
certifying body formed by act of 1952.
• BIS larger scope, build a climate for quality culture and greater
participation of consumers in formulation and implementation of
standards.
• President: Union minister of consumer affairs

5. 4 schemes of BIS
• Product certification scheme
• ISI mark
• ECO mark
• Process certification scheme
• ISO 9001
• Testing
• NABL: ISO 17011- conformity assessment- Requirements for accrediting
bodies accrediting conformity assessment bodies
• Hallmarking- Gold

6. NABL accreditation
• NABL signatory status across APLAC (by Mutual recognition
agreement) and ILAC (based on peer evaluation), therefore, mutual
acceptance of tests results and measurement data across Indian
borders.
• Provides accreditation for
• ISO 17025-Testing and calibrating laboratories
• ISO 17043-General requirements for proficiency testing
• ISO 15189- Medical laboratories- requirements for quality and competence

7. ISO 15189; 2012 Standard
• Standard based on ISO 17025 and ISO 9001
• 2 major clauses
• Management requirements
• 15 subclauses
• Technical requirements
• 10 subclauses
• Clauses and sub clauses arranged in logical sequence

8. ISO 15189
Technical requirementsManagement requirements
1) Management responsibility
2) Quality management system
3) Document control
4) Service agreement
5) Examination by referral laboratories
6) External services and supplies
7) Advisory services
8) Resolution of complaints
9) Identification of non conformities
10) Corrective action
11) Preventive action
12) Continual improvement
13) Control of records
14) Evaluation and audits
15) Management review
1. Personnel
2. Accommodation and environment
3. Laboratory equipment, reagent and
consumables
4. Pre examination process
5. Examination process
6. Ensuring quality of examination
result
7. Post examination process
8. Reporting of results
9. Release of results
10. LIS

9. 4.1 Organization
Legally registered
entity
Ethical conduct Laboratory director
1. Proprietorship
firm
2. Private Ltd firm
3. Public limited
company
4. Trust
1. Confidentiality
of results
2. Compromised
staff behaviour
3. Undue pressure
by mgmt.
1. Qualification
2. Experience
3. JD within the
organization

10. 4.1 Management responsibility and
commitment
Services tailored
toward need of
users
Quality policy and
objectives
Organization
structure and
communication
pattern defined
Appoint a Quality
manager

11. 4.2, 4.3 Quality management system
Documents &
document control
InternalExternal Records
e.g. ISO 15189;
2012, Dacie and
Lewis, Hoffman,
AABB, etc.
SOP, QSP, QM
Evidence of
action

12. 4.4 Service agreements
Entering and fulfilling a
service agreement
Review of a service
agreement
Every time the laboratory
accepts a request it is
considered to be a service
agreement, therefore,
 Infrastructure and
facility
 Qualified and trained
staff
 Procedure to inform
customers in case of
deviation
 In case test referred
outside should be
mentioned.
1. All aspects of service
shall be reviewed
periodically.
2. If agreement
amended after
commencement of
service, informed to
affected parties.

13. 4.5 Referral laboratories
Procedure to select
referral laboratories and
consultants
1. Competency of lab or
consultant
2. Periodic review of
scope of test and
compliance with NABL.
3. Register of reference
laboratories
4. List of requests
referred to the referral
lab.
Final report properties:
1. Clearly indicated parts
of examination that
have been sourced.
2. Referral lab result
interpreted to meet
referring lab user
needs.

14. 4.6 External services and supplies
1. Selection of reagents and consumables
2. Vendor evaluation
a) Price of goods
b) Timeliness
c) Consistency in quality

15. 4.7 Advisory services
Guide physicians hand in appropriate
decision making by provision of
expert consultancy services regarding
tests carried out by lab and their
interpretation.

16. 4.8 Resolution of complaints
Procedure and records
Feedback and complaints from stakeholders
Records for complaints and proof of investigation

17. 4.9 Identification and
control of non
conformities
4.10 Corrective action 4.11 Preventive action
4.12 Continual
improvement

18. 4.13 Control of records
1. Clearly identified
2. Retention period defined
3. Access controlled
4. Facility for safe disposal

19. 4.14 Evaluation and audits
Periodic Evaluation Audits
1. Suitability of examination
procedures and sample
requirements
2. Feedback assessment
3. Staff suggestion
4. Risk analysis
5. KPI’s
Internal ExternalUnscheduled

20. 4.15 Management review
• Meeting with top management
• Summary of the entire years performance
• Opportunity of staff to interact with top management

21. 5.0 Technical requirements

22. 5.1 Personnel
(Who will you
hire to get the
job done?)
• Adequately qualified
• Clear JD
• Induction strategy
• Training on quality, safety, ethics and
confidentiality
• Competence assessed
• Periodic review of staff performance
• Provision for continuous education
• Records

23. 5.2
Accommodation
and environment
• Separate laboratory and office facilities
• Storage facilities
• Staff lounges and washrooms
• Sample collection facilities
• Effective system for maintenance and upkeep of facility

24. 5.3 Equipment,
reagent and
consumables
• IQ- Hardware, software, s#, user manuals, computer
requirements
• OQ- performing as per manufacturers claims
• PQ- Calibration and traceability of calibrator, range of
testing, +MU or CV% calculated
• Facility for repairing and reporting adverse events
• Records for the same

25. 5.3 Reagents and
consumables
• Facilities for
• Reception and storage
• Acceptance for testing
• Inventory management strategy
• Instructions for use
• Adverse event reporting
• Records for the same

26. 5.4 Pre examination
process
• Information to patients and users
• Request form information
• Primary sample collection and
handling
• Sample transportation
• Sample reception
• Sample handling, preparing and
storage

27. 5.5 examination
process
• Validated procedure should be
used
• +MU or CV% defined
• Reference values defined
• SOP for examination process
prepared and circulated

28. 5.6 Ensuring quality of
examination results
• Quality control
• Review of QC data
• Inter lab comparison/EQAS
• Comparison of results from
different instruments

29. 5.7 Post examination
process
• Result review established
• Storage and disposal of primary
samples- identification, indexing,
retaining, accessing and discarding

30. 5.8 Reporting results
• Communicate information on
sample quality and suitability for
the examination
• Methodology used, patient
identity, lab identity, bio reference
intervals and interpretation where
appropriate, details of authorized
signatory releasing results.

31. 5.9 release of results
• Result released to authorized
person
• Communicate alert values and
quality compromised samples
• Software validation proof for
automated selection and transfer
of result
• Revised reports clearly indicated
and user intimated of revision

32. 5.10 LIS
• Access and range of authority
clearly defined
• Documents of software creation,
testing and validation available on
request
• Prevention against tampering and
unauthorized access
• Contingency plan in case of
downtime
• Back up of information