Revision of standard NF EN ISO/CEI 17025

Published in 1999, ISO/CEI 17025, drawn up by the ISO/CASCO technical committee (Committee on Conformity Assessment), specifies "general requirements for the competence of testing and calibration laboratories". This standard serves as a reference for the accreditation of calibration and/or testing laboratories (this does not include medical analysis laboratories, which are accredited to ISO 15189) wishing to demonstrate to their customers that they apply a management system that enables them to control all processes, that they have the technical competence and that they produce reliable and valid results. It should be remembered that under EC regulation 882/2004 –, which will be repealed by EC regulation 625/2017 on December 14, 2019 –, accreditation is mandatory for official control laboratories (e.g. National Reference Laboratories).

In France, the accreditation body responsible for recognizing the competence of laboratories under ISO/CEI 17025 is COFRAC (Comité Français d'Accréditation).

In order to harmonize requirements with ISO 9001 version 2000 (Quality management systems – Requirements), ISO/CEI 17025 was first updated in 2005.

The following years saw the emergence of new needs and new working practices for laboratories; technologies had evolved. We also had to take into account the new requirements of the ISO 9001 2015 version, notably on risk and opportunity management.

In 2015, more than 50 countries, including France, which played an active role, took part in the new revision of ISO/IEC 17025.