Basics of the Quality System Concept Module
BASICS OF THE QUALITY SYSTEM CONCEPT
Purpose:
To orient participants to the basics of the quality system concept
Learning
objectives:
At the end of this module, participants will be able to:
 Explain the importance of high quality laboratory service
 Describe the ISO standards and CLSI guidelines that apply
to quality laboratory management
 Name the essential elements of a laboratory quality system
 Define who is responsible for quality in the laboratory
Content Outline:
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Handout and
exercises:
Appendix:
Understanding the importance of high quality laboratory
service
ISO 15189 as a quality management standard for medical
laboratories
CLSI guidelines: a complementary role to ISO standards
The quality system outline
Key Messages
None
Quality System Essentials’ chart
UNDERSTANDING THE IMPORTANCE OF HIGH QUALITY LABORATORY SERVICE
Quality is now considered a compulsory element of health care and laboratory services.
People want to have products and services that fully meet their expectations especially if
it relates to their health. Accurate, reliable and timely laboratory results are essential to all
aspects of health care. Laboratory errors cost time, energy, personnel and money. The
quality of laboratory services is very important for a patient – some potential
consequences of laboratory misdiagnosis include delay in correct diagnosis, unnecessary
treatment, and other complications.
The mission of health laboratory services is to provide high quality services, in the right
place and in the right time, that meet the needs of patients, the community and/or health
staff, including clinicians as well as epidemiologists and environmental sanitarians. How
do we achieve excellent performance in the laboratory? Many different techniques and
concepts have been developed to improve the product and service quality. One of the
most well known and widely used documents that outlines the systemic approach to
quality is the ISO 9000 series of standards.
ISO (International Organization for Standardization) is the world's largest developer and
publisher of international standards, representing a network of the national standards
institutes of 159 countries with a Central Secretariat in Geneva, Switzerland. As a non1
Basics of the Quality System Concept Module
governmental organization, ISO forms a bridge between the public and private sectors,
which enables a consensus to be reached on solutions that meet both the requirements of
business and the broader needs of society. Standards ensure desirable characteristics of
products and services such as quality, environmental friendliness, safety, reliability,
efficiency and interchangeability - and at an economical cost.
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 a guideline for quality in manufacturing and service industries, with broad applicability
so it can be used by organizations of different types. Although very well known in
manufacturing industries, ISO standards are relatively new in healthcare and service
organizations. The ISO system has been catching the attention of more and more labs in
the last few years. 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.
ISO 15189 AS A QUALITY MANAGEMENT STANDARD FOR MEDICAL LABORATORIES
Medical laboratories are encouraged to establish quality management systems that
address their specific issues. 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 recognising the competence of medical
laboratories.
The ISO 15189 standard is divided in two major parts:
- Management requirements - generic requirements related to quality management
systems, including the outline for a quality manual;
- Technical requirements- specific requirements related to activities carried out by
clinical laboratories. This standard also provides two important annexes:
recommendations for LIS (Laboratory Information Systems) security and ethics in
laboratory medicine.
CLSI GUIDELINES: A COMPLEMENTARY ROLE TO ISO STANDARDS
The Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS)1 has also
published several guidelines that have quality as a focus and are based on the ISO
9001:2000 and 15189:2007 standards. Being closely tied to ISO standards, CLSI
guidelines help clinical laboratories to tailor ISO requirements to their needs and design
their quality management systems.
The CLSI guidelines include:
1
CLSI (formerly NCCLS, or the National Committee for Clinical Laboratory Standards) 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.
2
Basics of the Quality System Concept Module
-
HS1-A2 - A Quality Management System Model for Health Care; Approved
Guideline – Second Edition. This guideline describes a general quality
management system model for healthcare settings, which consists of 12 essentials.
-
GP26-A3 - Application of a Quality Management System Model for Laboratory
Service; Approved Guideline – Third Edition. The GP26-A3 guideline relates the
elements described in HS1 directly to the laboratory, describe the path of
laboratory workflow, and assist laboratories in improving processes.
THE QUALITY SYSTEM OUTLINE
So, why is a systematic approach to quality being emphasized? Very often people think
that a laboratory is just a working area where laboratory specialists work with reagents
and equipment to examine specimens and report examination results. In fact, the
laboratory operation consists of a complex system. The processes in the laboratory’s path
of workflow begin outside the laboratory boundaries with the request for a laboratory
examination and end outside the laboratory’s boundaries with decisions made by
healthcare professionals based on laboratory examination results in combination with
clinical signs and symptoms. It is very important that all parts of this cycle or all aspects
of the system work correctly. Any error in any part of the cycle can produce a poor
laboratory result with a negative impact on the patient. All aspects of the laboratory
operation need to be addressed to assure quality; this constitutes a quality system. Thus,
the quality system can be defined as organizational structure, resources, processes and
procedures needed to implement quality management.
According to CLSI, there are twelve essential elements or parts of the quality system
(please also refer to the Appendix of this Module). These are ‘Quality System Essentials’
(QSE’s) and are a set of coordinated activities that function as building blocks for quality
management. Each of the essential elements must be given attention in order to produce
good laboratory results. For example, the Assessment QSE includes External Quality
Assessment (EQA) which is an indispensable activity to demonstrate competency in the
laboratory.
The twelve quality system essentials defined by CLSI are:
-
Documents & Records
Organization
Personnel
Equipment
Purchasing and Inventory
Process Control
Information Management
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities and Safety
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Basics of the Quality System Concept Module
Application of a quality system approach will help ensure quality of the overall process,
detect and reduce errors, improve consistency within and between laboratories, contain
costs, and ensure customer satisfaction. In striving towards successful implementation of
a quality systems approach, it is necessary, above all, to understand that everyone in the
laboratory is responsible for quality.
KEY MESSAGES
- Accurate, reliable and timely laboratory results are essential to all aspects of
health care.
- The ISO 15189 standard is a valuable tool for developing an effective quality
management system in a laboratory.
- The CLSI guidelines are tied very closely to the ISO standards and are a way to
“translate” ISO standards into laboratory language.
- The rationale for applying a quality system approach is to ensure quality of the
overall process, detect and reduce errors, improve consistency within and between
laboratories, contain costs, ensure customer satisfaction.
- Everyone in the laboratory is responsible for quality.
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Basics of the Quality System Concept Module
Appendix
QUALITY SYSTEM ESSENTIALS
Organization
Personnel
Equipment
Purchasing
& Inventory
Process
Control
Information
Management
Documents
& Records
Occurrence
Management
Assessment
EXTERNAL
QUALITY
ASSESSMENT (EQA)
Process
Improvement
Customer
Service
Facilities
& Safety
Quality system essentials (QSE) are the set of coordinated activities
that function as building blocks for quality management.
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