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 KumudeshMSc/BSc/EDMgt/DMLT

2

Participants via CMLS.SL

TQM Malaysia

Participants via SHDP Fellowship

3TQM Malaysia

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)

TQM Malaysia 4

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

TQM Malaysia 5

Certification

TQM Malaysia 6

Certification

TQM Malaysia 7

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?

TQM Malaysia 8

Accreditation

Certification

Licensure

Which standards should the laboratory

use?

How does the

laboratory regard

regulation?

Does the laboratory need accreditation?

TQM Malaysia 9

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.

TQM Malaysia 10

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

TQM Malaysia11

Certification and

Accreditation Bodies

Competent staff

Objective

Standards-based

KnowledgeableApproved

TQM Malaysia 12

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)

TQM Malaysia13

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

TQM Malaysia 14

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

TQM Malaysia

15

European Committee for Standardization

▪ national standards bodies in the European

Economic Community and associated countries

▪ general terms include openness and transparency,

consensus, and integration

TQM Malaysia

16

World Health Organization

▪ has developed several standards for disease-

specific diagnostic laboratories, such as polio,

tuberculosis, influenza, measles

TQM Malaysia 17

Laboratory accreditation

• ISO 15189

• ISO 17025

TQM Malaysia 18

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.

TQM Malaysia 19

ISO 15189:2012

A set of requirements for Quality and Competence which helps standardize the management principles for medical laboratories anywhere in the world.

TQM Malaysia 20

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

TQM Malaysia 21

Scope of ISO 15189

Medical LaboratoryParticular

requirements for quality & competence

Laboratory QMtechnical processes

Qualityadministrative

technical systems

Based on ISO

17025:1999 &

9001:2000

to confirm or recognize competence

TQM Malaysia 22

Process for Accréditation

not one to be taken lightly or without forethought

Requirements

knowledge resources

commitment planning

TQM Malaysia 23

Requirements

• Management Requirements

• Technical Requirements

• Documents

TQM Malaysia 24

Management Requirements

TQM Malaysia 25

Technical Requirements

TQM Malaysia 26

Hierarchy of Documents

TQM Malaysia 27

Documents

• Duties and Responsibilities of Laboratory Director

• Quality Policy

• Quality Manual

• Procedures and Records (SOP, Work chart and Instructions, Records)

• Copies of Regulatory documents

TQM Malaysia 28

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

TQM Malaysia 29

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

TQM Malaysia 30

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

TQM Malaysia 31

• 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

TQM Malaysia 32

Driving Force• Laboratory Director Duties and Responsibilities

• Quality Manager Duties and Responsibilities

• Technical Manager Duties and Responsibilities

TQM Malaysia 33

Quality Manual

TQM Malaysia 34

TQM Malaysia 35

Documentation Required to Establish QMS

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

TQM Malaysia 36

Duties of Laboratory Director

TQM Malaysia 37

• Implement Policies

• Safe Laboratory Environment

• Clinical Advice

• Ensure Supplies

• Provide CPD program for Staff

• Handle Complaints

• Contingency Plan

• Effective Functions

Duties of Quality Manager

TQM Malaysia 38

• 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 andregular review of quality Manual

• Assist to maintaining document Control System,

• Maintain Technical Records

• Assist to control clinical material

• Participate to Management Review

Duties of Quality Manager

TQM Malaysia 39

• 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

40TQM Malaysia

Model Diagram

TQM Malaysia 41

Process of Accreditation

Laboratory

Licensure

Laboratory

Certification

ReferenceLaboratory

Accreditation

Where is your Laboratory?

TQM Malaysia 42

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

TQM Malaysia 43

Operationalization

Plan

Do

Study

Act

PREPAREDNESSPLANGAP ANALYSIS

IMPLEMENTATIONPROGRAM

EVALUATION

REVISIONMAINTENANCEREPORT CYCLEPREPARE TO PLAN

TQM Malaysia 44

Identification of Errors

TQM Malaysia 45

TQM Malaysia 46

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

TQM Malaysia 47

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

Challenges

• TIME

• EFFORT

• ENERGY

• MONEY

TQM Malaysia 48

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

TQM Malaysia 49

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

TQM Malaysia 50

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.

TQM Malaysia 51

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

CONTINUALIMPROVEMENT

QUALITYMANAGEMENT

CUSTOMERSATISFACTION

ACCREDITATION

ERRORREDUCTION

TQM Malaysia 52

TQM Malaysia 53