Laboratory Quality Management System
Training toolkit
Participant’s Guide – Table of contents and
overview
Laboratory Quality Management System – Training Toolkit
World Health Organization.
Laboratory Quality Management System - Training toolkit.
WHO/HSE/IHR/LYO/2009.1
Published by World Health Organization on behalf of the U.S. Centers for Disease Control
and Prevention; the World Health Organization; the Clinical and Laboratory Standards
Institute®.
© World Health Organization, 2009
The designations employed and the presentation of the material in this publication do not
imply the expression of any opinion whatsoever on the part of the World Health Organization
concerning the legal status of any country, territory, city or area or of its authorities, or
concerning the delimitation of its frontiers or boundaries.
The mention of specific companies or of certain manufacturers’ products does not imply that
they are endorsed or recommended by the World Health Organization, U.S. Centers for
Disease Control and Prevention or the Clinical and Laboratory Standards Institute in
preference to others of a similar nature that are not mentioned. Errors and omissions excepted,
the names of proprietary products are distinguished by initial capital letters.
WHO, U.S. Centers for Disease Control and Prevention and the Clinical and Laboratory
Standards Institute do not warrant or represent that the content of these training materials are
complete and/or error-free. WHO, U.S. Centers for Disease Control and the Clinical and
Laboratory Standards Institute disclaim all responsibility for any use made of the data
contained herein, and shall not be liable for any damages incurred as a result of its use. This
document must not be used in conjunction with commercial or promotional purposes.
Contacts
WHO Lyon Office
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Clinical and Laboratory Standards Institute
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customerservice@clsi.org
Laboratory Quality Management System – Training Toolkit
Table of contents
Section 1:
Overview
About this training toolkit
Contents of the training toolkit
Section 2:
Contents and training materials
Module 1:
Introduction
Module 2:
Facilities and Safety
Module 3:
Equipment
Module 4:
Purchasing and Inventory
Module 5:
Sample Management
Module 6:
Introduction to Quality Control
Module 7:
Quantitative Quality Control
Module 8:
Quality Control for Qualitative and Semi-Quantitative Procedures
Module 9:
Audits
Module 10: External Quality Assessment (EQA)
Module 11: Norms and Accreditation
Module 12: Personnel
Module 13: Customer Service
Module 14: Occurrence Management
Module 15: Process Improvement
Module 16: Document and Records
Module 17: Information Management
Module 18: Organization
Section 3:
Glossary
Section 4:
References
Laboratory Quality Management System – Training Toolkit
Section 1: Overview
Introduction
This section provides an overview of the content and the structure of the Laboratory Quality
Management System training toolkit:
o About this training toolkit
o Contents of the training toolkit
Laboratory Quality Management System – Training Toolkit
4
About this training toolkit
Background
Achieving, maintaining and improving accuracy, timeliness, and reliability are major
challenges for health laboratories. Countries worldwide committed themselves to build
national capacities for the detection of, and response to, public health events of international
concern when they decided to engage in the International Health Regulations implementation
process.
Only a sound management of quality in health laboratories will enable countries to produce
test results that the international community will trust in cases of international emergency.
Training laboratory managers, senior biologists, and technologists in quality management
systems is a step towards obtaining international recognition; it is a step that all countries
should take.
Note: Health laboratories, in this training package, is a term that is meant to be inclusive of
clinical laboratories, diagnostic laboratories, medical laboratories, public health laboratories,
or any other laboratories including animal and environmental health laboratories performing
testing for the purpose of disease diagnosis, screening or prevention, medical treatment
decisions, surveillance or public health. Because all these terms for laboratories are
frequently used interchangeably, the terms may likewise be used interchangeably in this
training package.
Key Words
laboratory quality management system, laboratory quality, laboratory information
management, laboratory information system, laboratory documents and records, laboratory
quality manual, quality control, laboratory facilities and safety, laboratory equipment,
laboratory sample management, laboratory sample transport, laboratory purchasing and
inventory, laboratory assessment, laboratory customer service, occurrence management,
process improvement, quality essentials, laboratory process control, clinical laboratory,
ISO 15189.
Laboratory Quality Management System – Training Toolkit
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Contents of the training toolkit
Materials in this toolkit consist of topics that are
essential for quality management of a public health or
clinical laboratory. They are based on both
ISO 15189 and CLSI GP26-A3 documents.
Each topic consists of a separate module. The
modules are organized following the framework
developed by CLSI and organized as the “12 Quality
System Essentials”. A diagram representing these 12
essentials is shown on the right.
The following table lists the available modules
grouped according to the 12 Quality System
Essentials, together with their respective learning
objectives.
Quality
System
Essentials
Facilities and
safety
Module
Learning objectives
Introduction




Facilities and
Safety





Equipment
Equipment




Purchase and
inventory
Purchasing
and
Inventory




explain the importance of a quality management system
list the quality management system essential elements
describe the history of development of quality principles
discuss relationship of this quality management system
model to ISO and CLSI standards
relate how facility design impacts the efficiency and safety
of laboratory workers
describe practices to prevent or reduce risks
list personal protective equipment (PPE) that should be
used routinely by laboratory workers
explain general safety requirements for the laboratory
describe steps to take in response to emergencies such as
biological or chemical spills, or laboratory fires
list items to consider prior to purchasing equipment for the
laboratory
manage the selection and acquisition of new equipment
describe the requirements for a preventive maintenance
program for equipment
provide a rationale for developing a preventive
maintenance program in your laboratory
explain how to retire old or outdated equipment
describe the steps required to implement an inventory
control program
name factors to consider in procurement of supplies
develop a monitoring plan for the inventory system
Laboratory Quality Management System – Training Toolkit
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
Process
control
Sample
Management





Process
control
Process
control
Introduction
to Quality
Control

Quality
Control for
Quantitative
Tests






Process
control
Quality
Control for
Qualitative
Tests





Assessment
Assessment
Audits
External
Quality
Assessment
(EQA)







Assessment
Personnel
Norms and

Accreditation


Personnel


discuss the importance of documentation related to
purchasing and inventory
name some sample collection errors that could lead to
incorrect laboratory examination results
list contents that should be included in a handbook
designed for people who collect samples off-site
provide a rationale for rejecting unsatisfactory samples
describe a system for sample handling, including
collection, transport, storage, and disposal
explain the importance of maintaining sample integrity and
assuring that all regulations and requirements are met when
transporting samples
define quality control and describe its relationship to the
overall quality management system
describe differences in quantitative, semi-quantitative, and
qualitative examinations
differentiate accuracy and precision
select control material for a specified examination method
establish acceptable control limits for a method when only
one level of control material is available
explain the use of a Levey-Jennings chart
give two examples of rule violations using Westgard
Multirule System
describe how to correct “out of control” problems
differentiate between built-in and traditional controls
describe how to use stock cultures for microbiology QC
discuss the use of quality control procedures for stains used
in microscopic examination
describe methods for verifying performance of
microbiological media
develop a process to prepare your laboratory staff for an
external audit
plan and manage an internal audit
discuss how to use results from a laboratory audit
advocate for the importance of taking corrective actions
discuss the importance of an EQA program in improving
the quality of laboratory test results
describe at least three EQA methods and the advantages
and disadvantages of each
outline a method to investigate an unacceptable test result
from an EQA sample
compare and contrast accreditation, certification and
licensure
describe the process involved in development of standards
discuss the need for laboratory norms and standards
describe the role of personnel in the quality management
system
develop a plan to verify employee competency
Laboratory Quality Management System – Training Toolkit
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
Customer
Service
Customer
Service
Occurrence
management
Occurrence
Management










Process
improvement

Process

Improvement 

Documents
and records
Documents
and Records






Information
management
Information
Management



Organization
Organization




describe the steps involved in assessing and maintaining
employee competency
explain a process to maintain personnel records
recognize the variety of laboratory customer groups
develop methods to measure customer satisfaction
discuss problems that may develop with customers
suggest solutions for customer service problems
discuss how quality management processes help the
laboratory meet customer group needs and requirements
define the term “occurrence”
describe the essential quality monitoring tools
differentiate among preventive action, remedial action, and
corrective action
describe the relationships between preventive action and
risk management practices
define and describe root cause analysis
relate the historical perspective of process improvement
describe the importance of process improvement in
maintaining quality
explain the need for tools to monitor laboratory processes
so problems can be identified and improved
explain the difference between documents and records
describe the hierarchy of documents and the role of each
level
outline the content that should be included in a standard
operating procedure
explain the important steps, or elements, of a laboratory
document management system
outline the contents of a quality manual
describe methods and tools to properly store documents
and records
describe important elements of an information
management system
explain things to consider when developing a manual,
paper-based information system
describe the advantages and disadvantages of a
computerized information management system
describe organizational elements needed for a quality
management system
discuss management roles and responsibilities in a quality
system
explain the process for designing, implementing,
maintaining, and improving the laboratory quality system
explain the purpose of a quality manual
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