Accreditation's gate in France

Healthcare section

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Legislation relating to medical biology renders compilsory, as of 16 January 2010, the accreditation of all medical biology laboratories (MBLs) in France. All MBLs, either public of private, must be accredited on all their activities on 31 October 2020 at the latest, with the end of administrative authorisations. Moreover, MBLs should be able to prove they entered the accreditation process before 30 October 2013.

It is for this purpose that Cofrac's Healthcare section was created in October 2009, essentially dedicated, at least initially, to the accreditation of MBLs. The section is also in charge of the accreditation of pathological anatomy and cytology entities.

Accreditation is based on the NF EN ISO 15189 standard, supplemented by the NF EN ISO 22870 standard for decentralised biological examinations. Those standards are mandatory in France and the general NF EN ISO 17025 standard cannot address all the requirements in medical biology.

The accreditation of MBLs is operated according to mandatory international and European regulations, for which Cofrac is responsible in France. As accreditation is an obligation in France, its implementation for MBLs is under state control, in accordance with the general principles of law, supplemented by legal (notably articles L6221-1 and those following of the Code of Public Health) and regulatory provisions (of which a part is still yet to be published), aiming to guarantee both the rights of MBLs and patients with the expected high-level sanitary safety.