Accreditation's gate in France

Healthcare section

Healthcare section

Healthcare section news

Click here to consult the latest news on the Healthcare section (in French).
Click here to consult the documentation relating to Healthcare section (in French).

Mission

Cofrac’s Healthcare section is in charge of all accreditation programs requiring a specific approach in terms of healthcare issues, relations with the medical sector, applicable international standards and, when appropriate, of legislative and regulatory context to be taken into account.

Thus, Legislation relating to medical biology renders compulsory, 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.

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.

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 section is also in charge of the accreditation of pathological anatomy and cytology entities, as well as the accreditation of forensic biology laboratories and relies on the NF EN ISO 15189 or the NF EN ISO/IEC 1705 standards. Its area of intervention could be widened to new technical medical procedures such as medical imaging for example.

Cofrac’ document SH INF 50 (in French) specifies the main domains opened to accreditation as of today by the Healthcare section.