Total Quality Management for

Medical Laboratories
ISO15189:2012

Ravi Kumudesh
MSc/BSc/EDMgt/DMLT

Senior Medical Laboratory Technologist, NHSL

Laboratory Manager, Outbreak Control Program
President, College of Medical Laboratory Science
Participants via CMLS.SL

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 Participants via SHDP Fellowship

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 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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 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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Certification

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Certification

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 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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 Does the
laboratory need
accreditation?
Accreditation

Licensure

Which How does

standards the
should the Certification
laboratory
laboratory regard
use? regulation?

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 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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 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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Approved Knowledgeable

Certification
and
Accreditation
Bodies Standards-
based
Competent
staff

Objective
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Standardization Bodies
International Organization for
Standardization (ISO)
Clinical and Laboratory Standards
Institute (CLSI)
European Committee for
Standardization (CEN)
World Health Organization (WHO)
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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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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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 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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 World Health Organization

has developed several standards for disease-

specific diagnostic laboratories, such as polio,
tuberculosis, influenza, measles

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 Laboratory accreditation
ISO 15189
ISO 17025

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 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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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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 Scope of ISO 17025
General tests
requirements calibrations
sampling
for competence
to confirm or
recognize
competence

testing & quality

calibration administrative
laboratories technical systems
Does not cover compliance with regulatory and safety requirements for
laboratory operations
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 Scope of ISO 15189
Based on ISO
17025:1999 & Medical Laboratory
9001:2000 Particular
requirements for
quality & competence
to confirm or
recognize
competence

Laboratory QM Quality
technical administrative
processes technical systems

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 Process for Accrditation
not one to be taken lightly
or without forethought

commitment planning

Requirements

knowledge resources

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 Requirements
Management Requirements
Technical Requirements
Documents

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Management Requirements

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Technical Requirements

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Hierarchy of Documents

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 Documents
Required to
Establish
QMS
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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Documentation Required to
Establish QMS

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 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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 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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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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 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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 Driving Force
Laboratory Director Duties and Responsibilities
Quality Manager Duties and Responsibilities
Technical Manager Duties and Responsibilities

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Quality Manual

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 Laboratory
implements
international or Director seeks information about
accreditation and
national standards certification processes

seeks information uses outcomes to

about appropriate provide better service
norms and standards

Responsibilities
Laboratorian Quality Manager
aware of requirements

contributes to meeting standards explains the process for

meeting standards to staff
aware of assessment processes
organizes the laboratory in
helps prepare for assessment preparation for assessments

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 Duties of Laboratory Director
Implement Policies
Safe Laboratory Environment
Clinical Advice
Ensure Supplies
Provide CPD program for Staff
Handle Complaints
Contingency Plan
Effective Functions
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 Duties of Quality Manager
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
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 Duties of Quality Manager
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

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 Where is your Laboratory?
Reference
Laboratory

Laboratory

Laboratory Accreditation

Certification

Licensure

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 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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 Operationalization
PREPAREDNESS
PLAN
Plan GAP ANALYSIS

REVISION
MAINTENANCE
REPORT CYCLE IMPLEMENTATION
PREPARE TO PLAN PROGRAM
Act Do

EVALUATION Study

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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

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Challenges
TIME
EFFORT
ENERGY
MONEY

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 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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 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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 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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 Accreditation does not guarantee success,
it is only one step along the quality journey

QUALITY
MANAGEMENT

ERROR CUSTOMER
REDUCTION SATISFACTION

CONTINUAL
IMPROVEMENT
ACCREDITATION

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