Quality assurance in the laboratories. ppt

Quality assurance in laboratories is crucial for ensuring the accuracy, reliability, and validity of test results and data generated. It encompasses a systematic approach to monitoring and improving processes to maintain high standards of performance and consistency.

1. Quality
assurance in
the
laboratories
Dr. Farida Begum

2. Why Quality Assurance in the
laboratories
–Ensuring the quality of analytical data in the laboratory is essential to
ensure ongoing customer confidence in any laboratory’s work, and this is
the purpose of quality assurance (QA).
–QA is typically ensured by having a quality management system (QMS).
Many organizations have also attained one or more QA standards

3. Introduction to quality
assurance (QA) standards
–There are a number of quality assurance (QA) standards designed to ensure quality. Some
are specific to a particular industry, while others are more general in their scope.
–The International Organization for Standardization (ISO) is responsible for producing many
standards. We will be considering the following standards:
–ISO 9001:2008 ‘Quality management systems –Requirements’
–• ISO/IEC 17025:2005 ‘General requirements for the competence of testing and calibration
laboratories’
–• ISO 15189:2007 ‘Medical laboratories –Particular requirements for quality and
competence’
–• Good Laboratory Practice (GLP) • Good Manufacturing Practice (GMP).

4. Introduction to quality assurance
(QA)standards
–ISO 9001 is a widely applied general standard that can be applied to any form of
manufacturing or service industry. The other standards are specific to the analytical and
pharmaceutical industries.
–ISO 17025 is designed for laboratories that test and calibrate materials and equipment.
–ISO 15189 is specifically for clinical (medical) laboratories.
–Good Laboratory Practice (GLP) applies to the safety testing that new chemicals and
pharmaceuticals have to undergo before they are sold or used commercially.
–Good Manufacturing Practice (GMP) is the standard that regulates the manufacture of
pharmaceuticals.

5. ISO 9001:2008
–ISO 9001:2008 is primarily concerned with enabling an organization to ensure the quality
of a product or service.
–It is very general in its scope as it is intended to be applicable across both the service and
manufacturing sectors, and it has been widely adopted in the chemical industry.
–It is concerned with what the organization should do to ensure that the customer’s
requirements are understood and met and that any applicable regulatory requirements
are achieved.
–ISO 9001:2008 is the latest version of the standard –the 2008 refers to the year in which
this version of the standard was adopted.

6. ISO 17025:2005 and ISO 15189:2007
–The ISO 17025:2005standard most relevant and applicable to analytical laboratories is
ISO/IEC 17025:2005 ‘General requirements for the competence of testing and calibration
laboratories’.
–Doctors rely on accurate and rapid analyses of clinical samples for the correct diagnosis and
treatment of patients. ISO 15189 is aimed at ensuring that results of tests in clinical
laboratories are of an appropriate standard.
–As clinical samples are taken from patients, correct sample collection, transport and storage
are crucial given that samples may be a biological hazard and may deteriorate quickly.
Traceability of the sample and its analytical results to the originating patient is also
essential –the consequences of assigning the wrong result to a patient could be fatal.