Annex E. Standardisation and accreditation bodies

Accreditation is a formal declaration by a neutral third party used to verify that laboratories have an appropriate quality management system and can properly perform certain test methods (e.g., ANSI, ASTM, and ISO test methods) and calibration parameters according to their scopes of accreditation. Organisations that issue credentials or certify third parties against official standards are themselves formally accredited by accreditation bodies, such as United Kingdom Accreditation Service (UKAS).

The International Organisation for Standardisation (ISO) is an independent, non-governmental membership organisation and the world's largest developer of International Standards with a central secretariat based in Geneva, Switzerland. The ISO story dates back to 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’1.

In this organisation, different industries define their specific technical standards and quality management requirements and issue ISO standards to guide conformity. ISO also standardises in vitro methods. Companies and organisations working according to ISO guidelines can ask for a conformity check and certification by independent accreditation bodies. ISO itself is not a controlling body, but has established a committee on conformity assessment (CASCO) guiding certification organisations.

While the OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025 both set out requirements for quality management systems under which testing is conducted, they have, as a result of their evolution and history, different purposes (OECD, 2016[1]).

ISO/IEC 17025 is an international standard intended to be applied by laboratory facilities conducting testing, according to established or specifically developed methodologies. The focus of the standard is on the on-going operation, monitoring and management of the laboratory itself, and on the capacity of the laboratory to produce consistent and reliable results that are scientifically valid. ISO/IEC 17025 can, in theory, be applied to any testing laboratory in any scientific discipline including those performing non-clinical testing. It is a reliable indicator of technical competence, and many industries routinely specify laboratory accreditation for suppliers of testing services.


[1] OECD (2016), OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025, OECD Series on Principles of GLP and Compliance Monitoring, No. 18, OECD Publishing, Paris.

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