Introduction To Quality Management System-Standard Guidelines & Accreditation

Introduction to Quality
Management System-Standard
Guidelines & Accreditation
– by Sayan Ghoshal
Quality Management System
A laboratory, just like any other organization, consists of

numerous processes.The core process of the laboratory is
the primary process consisting of three stages: the pre-
analytical stage (the sample is collected, received at the
laboratory, registered and processed), the analytical stage
(the actual laboratory test is performed and the result is
recorded), and the post-analytical stage (the result is
authorized, reported and archived and the sample is
discarded/archived).
A Quality Management System

affects each single process of the
laboratory and consists of several
layers. You can see this as a
pyramid:
The basis of the pyramid consist of

Inspection. Structured, concious
and rational inspection of process
performance is called quality
control.
The implementation of control

steps at strategic logical points in
each process of the laboratory to
monitor correct performance and
quality output is termed as Quality
Assurance.
The decision of the strategic

logical points in each process of
the laboratory is in turn termed as
Quality System and collectively
called as the Quality Management
System.
A quality management system

can be described as a set of
building blocks needed to
control, assure and manage
the quality of the laboratory's
processes. A system used in
this tool is the framework of
12 building blocks, called
quality system essentials
(QSEs).
By ensuring that all the
processes related to the QSEs
perform correctly, quality can
be assured. For example: to
control and assure quality,
good trained personnel is
necessary. Each personnel
member also needs to know
exactly what he/she needs to
do, which is achieved through
job descriptions. The
performance of personnel
members needs to be
periodically evaluated.
Standard Guidelines
A technical committee of the

International Organization for
Standardization (ISO) has formulated
requirements for quality and
competence in medical laboratories.
These requirements were recorded
in a document and published as the
ISO 15189 quality standard. This
standard is internationally recognized
and used as the standard for
accreditation of medical laboratories.
Standard Guidelines
Besides ISO 15189, there are also guidelines. These documents are more
descriptive, providing more information on the systems approach and
philosophy behind the requirements of standards. A good example of a
quality guideline is the Clinical and Laboratory Standard Institute's (CLSI)
guideline for implementation of quality management in medical
laboratories.
Accreditation
Accreditation is a recognition of the
laboratory's quality and competence.
Accreditation is achieved when the laboratory
has a quality management system in place
that complies with the requirements of the
ISO 15189 quality standard.To accredit a
laboratory an independent notified
accreditation body assesses the laboratory to
investigate if the quality management system
indeed functions as it is supposed to and if it
complies with the quality standard. This
accreditation body itself also operates
according to a standard (ISO/IEC 17011) and is
affiliate/member of the International
Laboratory Accreditation Cooperation (ILAC).
Accreditation
Accreditation is a recognition of the laboratory's
quality and competence. Accreditation is achieved
when the laboratory has a quality management system
in place that complies with the requirements of the
ISO 15189 quality standard.To accredit a laboratory an
independent notified accreditation body assesses the
laboratory to investigate if the quality management
system indeed functions as it is supposed to and if it
complies with the quality standard. This accreditation
body itself also operates according to a standard
(ISO/IEC 17011) and is affiliate/member of the
International Laboratory Accreditation Cooperation
(ILAC). One such accreditation body in our country is
NABL - National Accreditation Board for Testing &
Accreditation
A certificate of accreditation is usually

provided for a period. During this period
the laboratory is re-assessed on a regular
basis. Hence, the work doesn't end after
the laboratory receives accreditation. The
quality management system needs to be
continually maintained and improved to be
able to continually assure quality and stay
accredited.
Accreditation
With certification the organization is only technically assessed. An example of

a question the assessor tries to answer is: "Are procedures for examinations
existent within the quality management system?"
With accreditation an organization's competency is also assessed. A question
the assessor tries to answer now is: "Are procedures for examinations
existent within the quality management system that are performed correctly,
by persons that are demonstrably competent to perform the procedures?"
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Introduction to Quality

A laboratory, just like any other organization, consists of

A Quality Management System

The basis of the pyramid consist of

The implementation of control

The decision of the strategic

A quality management system

A technical committee of the

A certificate of accreditation is usually

With certification the organization is only technically assessed. An example of

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