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Published on Laboratory Quality Stepwise Implementation tool (https://extranet.who.int/lqsi)
Home > Quality Management
Quality Management
What is quality management and what is a quality management system?[1]
What are quality standards and guidelines?[2]
What is accreditation? [3]
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). [4]
Accreditation is often seen as a final destination. However, this couldn't be more wrong; accreditation is only
the beginning. A certificate of accreditation is usually provided for a period of 4 - 5 years. 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.
What is the difference between accreditation and certification?
Sometimes confusion exists between the terms "Accreditation" and "Certification".
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 p