1. International Training on Total Quality
Management for Medical Laboratories
ISO15189:2012
Senior Medical Laboratory Technologist, NHSL
Laboratory Manager, Outbreak Control Program
President, College of Medical Laboratory Science
Ravi Kumudesh
MSc/BSc/EDMgt/DMLT

2. 2
Participants via CMLS.SL
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3. Participants via SHDP Fellowship
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4. Institutes involved
• Creative Malaysia Training Center (CMTC)
CMTC is a highly successful training company specializing in corporate training markets.
CMTC is categorised as a five star training provider in areas such as; management and
accreditation, finance and accounting, HR, IT, and Project management.
• Scientific and Industrial Research Institute (SIRIM)
This is a corporate organisation owned wholly by the Malaysian Government,
under the Minister of Finance Incorporated. SIRIM is mandated as the machinery
for research and technology development, and the national champion of quality.
SIRIM QAS International is Malaysia's certification, inspection and testing body.
• University of Malaya (UoM)
The University of Malaya is a public research university located in Kuala Lumpur,
Malaysia. It is the oldest and most esteemed university in Malaysia. Two type of
accredited Laboratories are maintain by this university as a Research Lab (ISO
17025) and Medical Lab (ISO 15189)
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5. What we obtained
Confidence on
• Quality Management System ISO 15189:2012
• Implementation of ISO 15189:2012
• Internal Auditing of ISO 15189:2012
• Measurement of uncertainty 17025:2005 as a
technical aspect
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6. Certification
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7. Certification
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8. Imagine…
Hospital Director asks from us as Laboratory
Managers, to implement Quality Management System
(QMS)in our hospital laboratory..
• What does it mean by QMS, standardization, accreditation
and certification?
• What are the relevant authorities and organizations?
• Are we aware of those?
• Are we competent for work on QMS and implementation?
• What would be the process?
• How would I get started?
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9. Accreditation
Certification
Licensure
Which
standards
should the
laboratory
use?
How does
the
laboratory
regard
regulation?
Does the
laboratory need
accreditation?
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10. Definitions
• Certification (ISO/IEC 17000)
– Procedure by which a third party gives written assurance that a product,
process or service conforms to specific requirements.
• Accreditation (ISO 15189)
– Procedure by which an authoritative body gives formal recognition that a body
or person is competent to care out specific tasks.
• Licensure (Wikipedia 2007)
– Granting of ability to practice provided most often by a local governmental
agency, usually based on demonstrated knowledge, training and skills.
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11. Self-developed Standards
Many agencies, organizations, or regions develop their own
accreditation requirements rather than using internationally
recognized standards.
• Advantages:
– optimized for local use, recognized local strengths and weaknesses
– can be developed in progressive steps
– can lead to full international recognition
• Weaknesses:
– may be narrow or biased
– may not be recognized by other organizations
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12. Certification
and
Accreditation
Bodies
Competent
staff
Objective
Standards-
based
KnowledgeableApproved
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13. Standardization Bodies
International organizations include:
▪ International Organization for Standardization (ISO)
▪ Clinical and Laboratory Standards Institute (CLSI)
▪ European Committee for Standardization (CEN)
▪ World Health Organization (WHO)
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14. International Organization for Standardization
▪ world's largest developer and publisher of
international standards
▪ standards are applicable to many kinds of
organizations including clinical and public health
laboratories
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15. Clinical and Laboratory Standards Institute
▪ global, nonprofit, standards-developing organization
▪ promotes the development and use of voluntary
consensus standards and guidelines within the health care
community
▪ documents are developed by experts working on
subcommittees or working groups
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16. European Committee for Standardization
▪ national standards bodies in the European
Economic Community and associated countries
▪ general terms include openness and transparency,
consensus, and integration
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17. World Health Organization
▪ has developed several standards for disease-
specific diagnostic laboratories, such as polio,
tuberculosis, influenza, measles
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18. Laboratory accreditation
• ISO 15189
• ISO 17025
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19. International Laboratory
Accreditation Cooperation
• ILAC is the international organisation for accreditation
bodies
• ILAC and ISO have a long standing relationship.
• ILAC has an ‘A’ liaison status within the ISO Committee
on Conformity Assessment (CASCO) as well as a
number of the ISO technical committees.
• ILAC is also involved in a number of the ISO working
groups for developing standards.
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20. ISO 15189:2012
A set of requirements for
Quality and Competence
which helps standardize
the management principles
for medical laboratories
anywhere in the world.
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21. Scope of ISO 17025
Does not cover compliance with regulatory and safety requirements for
laboratory operations
General
requirements
for competence
testing &
calibration
laboratories
quality
administrative
technical systems
tests
calibrations
sampling
to confirm or
recognize
competence
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22. Scope of ISO 15189
Medical Laboratory
Particular
requirements for
quality & competence
Laboratory QM
technical
processes
Quality
administrative
technical systems
Based on ISO
17025:1999 &
9001:2000
to confirm or
recognize
competence
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23. Process for Accréditation
not one to be taken lightly
or without forethought
Requirements
knowledge resources
commitment planning
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24. Requirements
• Management Requirements
• Technical Requirements
• Documents
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25. Management Requirements
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26. Technical Requirements
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27. Hierarchy of Documents
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28. Documents
• Duties and Responsibilities of Laboratory Director
• Quality Policy
• Quality Manual
• Procedures and Records (SOP, Work chart and
Instructions, Records)
• Copies of Regulatory documents
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29. Documents in Management
Requirements
• Document for Document Control
• Procedure for service agreements
• Procedure for selecting referral lab
• Procedure for selecting and purchasing external services
• Procedure for complaint management
• Procedure for identifying and managing nonconformities
• Documents for corrective actions
– reviewing nonconformities
– Determining root causes of nonconformities
– Evaluating need of corrective actions
– Determining and Implementing corrective action
– Recording corrective action taken
– Review the effectiveness of corrective action
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30. Documents in Management
Requirements contd.
• Documents for preventive actions
– reviewing data to identify potential nonconformities
– Determining root causes of potential nonconformities
– Evaluating need of preventive actions
– Determining and Implementing preventive action
– Recording preventive action taken
– Review the effectiveness of preventive action
• Procedure for document control
– identifying, collection, indexing, access, storage, maintenance,
amendments, safe disposal of records
• Document for internal audit
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31. Documents in Technical Requirements
• Document for personal qualification for each position
• Job descriptions
• Process for introducing new staff member
• Document for selecting purchasing and management of
equipment
• Calibration procedure
• Procedure for Preventive maintenance of equipment
• Procedure for reception, storage, acceptance testing and
inventory management of reagents and consumables
• Procedure and information for pre examination activities
• Procedure for accepting verbal requests
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32. • Procedures for collection and handling specimens
• Procedure for sample transportation monitoring
• Procedure for specimen reception with acceptance rejection criteria
• Procedure for specimen storage
• Validated Examination Procedures
• Documents on verification and validation of examination procedures
• Record of measurement of uncertainty and performance requirement for uncertainty
• Defined reference intervals
• Examination Procedures
• Procedure for preventing release results when QC fail
• identifying, collection, retention, indexing, access, storage, maintenance,, safe disposal
of clinical specimens
• Procedure for releasing results
• Procedure for ensuring confidentiality of patient information
• Procedure for contingency plan to maintain services when IS fails
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33. Driving Force
• Laboratory Director Duties and Responsibilities
• Quality Manager Duties and Responsibilities
• Technical Manager Duties and Responsibilities
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34. Quality Manual
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Documentation Required to
Establish QMS

36. explains the process for
meeting standards to staff
organizes the laboratory in
preparation for assessments
aware of requirements
contributes to meeting standards
aware of assessment processes
helps prepare for assessment
Responsibilities
implements
international or
national standards
seeks information
about appropriate
norms and standards
seeks information about
accreditation and
certification processes
uses outcomes to
provide better service
Laboratorian Quality Manager
Laboratory
Director
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37. Duties of Laboratory Director
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• Implement Policies
• Safe Laboratory Environment
• Clinical Advice
• Ensure Supplies
• Provide CPD program for Staff
• Handle Complaints
• Contingency Plan
• Effective Functions

38. Duties of Quality Manager
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• Ensuring establishment of QMS
• Implementation and Maintain QMS
• Maintain Quality policy
• Assist to documentation of Quality Objective
• Assist to establishment of Quality Objective
• Crate awareness of users in the lab
• Assist preparation, administration, dissemination and
regular review of quality Manual
• Assist to maintaining document Control System,
• Maintain Technical Records
• Assist to control clinical material
• Participate to Management Review

39. Duties of Quality Manager
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• For some, such as UKAS ISO 15189 accreditation, the
appointment of a Quality Manager is mandatory
• The Quality Manager is the individual
with responsibility as a management representative
for ensuring all aspects of quality within a quality
management system

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Model
Diagram

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Process of Accreditation

42. Laboratory
Licensure
Laboratory
Certification
Reference
Laboratory
Accreditation
Where is your Laboratory?
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43. Route for Accreditation
• Read the document.
• Does it meet your needs?
• Perform a Gap Analysis
• Prepare the Laboratory
• Develop an implementation plan
• Repeat the Gap Analysis?
• Determine your state of readiness
• Make the Accreditation decision
• Commit to the standard
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44. Operationalization
Plan
Do
Study
Act
PREPAREDNESS
PLAN
GAP ANALYSIS
IMPLEMENTATION
PROGRAM
EVALUATION
REVISION
MAINTENANCE
REPORT CYCLE
PREPARE TO PLAN
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45. Identification of Errors
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Accreditation Terms
Consensus
▪ represents general agreement in the absence of strong and
compelling objection
Normative Statement
▪ required and essential part of the standard
▪ includes the word “shall”
Informative Statement
▪ information (often a ‘note’) that may be explanatory, or
cautionary, or provide an example

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Accreditation Terms
Compliance
▪ meets both the text and the spirit of a requirement
Non-conformity
▪ failure to fulfill the requirements of a specified process,
structure or service
▪ may be categorized as major (complete) or minor (partial)
Verification of conformity
▪ confirmation by examination of evidence

48. Challenges
• TIME
• EFFORT
• ENERGY
• MONEY
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49. Target should
• Not only as a Marketing tool
• Not only for Certification
• But it is for
Functional approach
Map the future Medical Laboratory Service
in Sri Lanka
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50. Accreditation outcomes
▪ strength and integrity of the quality system are
measured
▪ continual monitoring of the quality system
▪ recognition for efforts
▪ Perform better on proficiency testing
▪ Are more likely to have a working quality
management system
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51. Key Messages
• Accreditation is an important step in the
continual improvement of the quality
management system.
• It is an accomplishment to be accredited; it is
an achievement to maintain accreditation.
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52. Accreditation does not guarantee success,
it is only one step along the quality journey
CONTINUAL
IMPROVEMENT
QUALITY
MANAGEMENT
CUSTOMER
SATISFACTION
ACCREDITATION
ERROR
REDUCTION
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