Quality Management

What is quality management and what is a quality management system?

What are quality standards and guidelines?

A technical committee that consists of an international group of experts 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 laboratories: if laboratories have implemented a quality management system that complies with all the requirements formulated in the ISO 15189 standard it can be accredited. The accreditation bodies that assess the compliance of laboratories with ISO 15189 are united in the International Laboratory Accreditation Cooperation (ILAC).

As ISO 15189 is an international quality standard, countries can also choose to formulate national quality standards based, or not based on ISO 15189, which can either be stricter or less strict compared to ISO 15189.

Besides quality standards, that merely sum up the requirements to a quality management system, 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) GP26 guideline for implementation of quality management in medical laboratories. The LQSI tool could also be regarded as a guideline.

For more information refer to the WHO Laboratory Quality Management System training handbook by clicking here.

What is accreditation?