Basics of quality system concept
BASICS OF THE QUALITY SYSTEM CONCEPT (OPTIONAL / National and
Higher Intermediate Level)
Purpose:
To provide participants with the basic terms and understanding
related to the laboratory quality management system concept
Module Time:
45 minutes
Learning
objectives:
At the end of this module, participants will be able to:
 Understand importance of high quality laboratory service
 Speak about ISO standards and CLSI guidelines in terms of
laboratory quality management
 Name essential elements of a laboratory quality system
 Know who is responsible for quality control in a laboratory
Module Overview
Step
Time
Activity/
Method
Content
Resources
Needed
1
5 min
Presentation
Understanding importance of
high quality laboratory service
Slides 3 - 4
2
15 min
Presentation
and
Discussion
ISO 15189 as a quality
management standard for
medical laboratories
Slides 5 - 9
3
5 min
Presentation
CLSI guidelines: a
complementary role to ISO
standards
Slides 10 - 12
4
15 min
Presentation
and
Discussion
The quality system outline
Slides 13 - 16
5
5 min
Summary
Key messages
Slide 17
Material/Equipment Checklists

PowerPoint slides

Computer w/LCD projector

Handouts:


The Quality System Essentials chart
Flipchart
TRAINER’S GUIDE
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Basics of quality system concept

Slide Number
1
Teaching Guide
Teaching Points
Module 2: The Basics of The Quality System Concept
DISPLAY this slide before you begin the module. Make sure
participants are aware of the transition into a new module.
2
Flipchart
Content Overview
(Suggested technique for presentation)
WRITE the content outline before beginning this session.
REFER to flipchart frequently to orient participants to where they
are in the module.
EXPLAIN that these are the topics that will be covered in this
module.
3
Importance of High Quality Laboratory Service
STATE it is obvious that the quality of laboratory services is very
important for a patient - the consequences of laboratory
misdiagnosis can be a delay in correct diagnosis, an unnecessary
treatment, and other complications.
4
Mission of Health Laboratory Services
STATE the mission of health laboratory services is to provide high
quality services, in the right place and in the right time, in respect of
the needs of patients, the community and/or health staff, including
not only clinicians but also epidemiologists and environmental
sanitarians.
5
Importance of Quality Systems
INITIATE discussion. ASK participants’ opinion regarding what
should be done to achieve the excellent performance in a
laboratory.
EXPLAIN that many different techniques and concepts have been
developed to improve product or service quality. The most famous
and widely used document that outlines the systemic approach to
quality is the ISO 9000 series of standards.
TRAINER’S GUIDE
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Basics of quality system concept
Slide Number
6
Teaching Points
International Organization for Standardization (ISO)
DEFINE ISO as the International Organization for Standardization.
EXPLAIN that ISO – a non-governmental organization – is a
federation of the national standards bodies of 149 countries, one per
country, from all regions of the world, including developed,
developing and transitional economies. Each ISO member is the
principal standards organization in its country. The members
propose the new standards, participate in their development and
provide support in collaboration with ISO Central Secretariat for
the 3000 technical groups that actually develop the standards.
ISO members appoint national delegations to standards committees.
In all, there are some 50 000 experts contributing annually to the
work of the Organization. When their work is published as an ISO
International Standard, it may be adopted as a national standard by
the ISO members and translated.
7
ISO 9000 Family
STATE the ISO 9000 family of international quality management
standards and guidelines, and ISO 9001:2000, Quality management
system – Requirements, in particular, has earned a global reputation
as the basis for establishing quality management systems (QMS).
This is the guidance for quality in manufacturing and service
industries. It has broad applicability and can be used by
organizations of different types.
8
ISO Documents - Laboratory
EXPLAIN that ISO standards are relatively new in healthcare and
service organizations. However, one of the most recent ISO
publications – ISO 15189:2007, Medical laboratories - Particular
requirements for quality and competence - was developed as a
guideline for the implementation of quality systems in medical
(clinical) laboratories, complementing the ISO 9001:2000
international standard.
STATE that ISO 15189 is intended for use by medical laboratories
in developing their quality management systems and assessing their
own competence, and for use by accreditation bodies in confirming
or recognizing the competence of medical laboratories.
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Basics of quality system concept
Slide Number
9
Teaching Points
ISO 15189:2007: Content
EXPLAIN that the content of ISO 15189:2007 includes two major
parts - management requirement and technical requirements. The
standard has also several annexes: Correlation with ISO 9001:2000
and ISO/IEC 17025:2005; Recommendations for protection of
laboratory information systems (LIS); Ethics in laboratory
medicine.
10
Clinical and Laboratory Standards Institute (CLSI)
EXPLAIN that effective 1 January 2005, nearly four decades into
its history, global standards-development organization NCCLS
changed its name to Clinical and Laboratory Standards Institute
(CLSI). CLSI is an international, interdisciplinary, nonprofit,
standards-developing, and educational organization that promotes
the development and use of voluntary consensus standards and
guidelines within the healthcare community. Today CLSI has
approximately 2,200 members as well as more than 2,000
volunteers who participate in the consensus process. With this level
of participation they are able to offer more than 160 standards,
guidelines and best practices and distribute more than 75,000
documents annually.
ADD that CLSI serves as secretariat of ISO Technical Committee
212, Clinical laboratory testing and in vitro diagnostic test systems
and its working groups, managing standards development in these
fields on behalf of the global healthcare community.
11
CLSI Quality Standards
EXPLAIN that the CLSI quality standards documents are tied very
closely to the ISO standards. HS1 is a general quality management
system model for health care settings. GP 26-A3 relates the
elements described in HS1 directly to the laboratory. The CLSI
standards are a way to “translate” ISO standards into laboratory
language, provide a somewhat simpler model, but are completely
compatible with ISO standards.
12
ISO vs. CLSI
EXPLAIN that CLSI documents provide the practical, step-by-step
processes for organizations to successfully implement relevant
CLSI and ISO standards.
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Basics of quality system concept
Slide Number
13
Teaching Points
Quality System
READ the definition of the quality system.
EXPLAIN that to be sure that all parts of a complex laboratory
system are working properly, a quality system addressing all
aspects needs to be set up. Thus, the quality system can be defined
as organizational structure, resources, processes and procedures
needed to implement quality management.
14
Quality System Essentials
PROVIDE participants with the printed copies of the Quality
System Essentials (QSE) chart.
EXPLAIN that according to CLSI a quality system model consists
of 12 essentials which are the set of coordinated activities that
function as building blocks for quality management.
ASK participants to read aloud all QSEs.
INITIATE discussion. ASK participants which QSE in their
opinion is the most important one, and why.
EMPHASIZE that each essential must be given attention in order to
produce good laboratory results.
POINT OUT that external quality assessment (EQA) forms an
indispensable part of a quality system under an Assessment quality
system essential.
15
Application of a Quality System Approach
STATE that application of a quality system approach will help
ensure quality of overall process, detect and reduce errors, improve
consistency within and between laboratories, contain costs, ensure
customer satisfaction.
16
Who Is Responsible for Quality in the Laboratory?
EMPHASIZE that striving towards a success in implementing
quality and competence, it is necessary, above all, to understand
that everyone in the laboratory is responsible for quality.
17
Key Messages
STATE the message on the slide. ANSWER any questions the
participants may have.
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