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"Healthcare" division

As its name indicates, the Healthcare division is responsible, within Cofrac, for the accreditation of everything related to health and the medical sector, and in particular biomedical laboratories.

At the end of 2017, 864 French biomedical laboratories were accredited (99% of them).

  • 937 assessments carried out in 2017
  • 47 employees  

Our Healthcare division is the most recent division of Cofrac. It was created in 2009 to fulfil the requirement to accredit all biomedical laboratories in France. Since then, our Healthcare division has also accredited forensic biology laboratories and anatomy and cytopathology (ACP) structures.

What are the specific characteristics of laboratory accreditations ?

Biomedical laboratories

Our Healthcare division covers all examination activities carried out by biochemistry, genetics, haematology, immunology, reproductive biology and microbiology laboratories.

Biomedical laboratories are subject to standard ISO 15189, recognised as a standard of excellency worldwide. It is complemented by standard ISO 22870 for point-of-care testing. In accordance with the international regulations, the accreditation of biomedical laboratories is founded on a peer assessment of practices, with the support of quality assessors. Its objective is to guarantee the reliability of the examinations and the quality of the services offered by the laboratories, in the interests of patients.

See Cofrac document SH INF 50: Standard accreditation scopes

Forensic biology laboratories.

Unlike biomedical laboratories, you are not required to have your activities accredited. However, accreditation is vital for guaranteeing the competence and reliability of the examinations you carry out in the framework of criminal procedures (genetic analyses for human identification, etc.) or civil procedures (paternity, maternity tests, etc.). Its scope covers biology-biochemistry, molecular genetics, toxicology, human doping tests, hematocytology and forensic entomology. The applicable standard is ISO/IEC 17025.

See Cofrac document SH INF 50: Standard accreditation scopes

Other areas and prospects for development

Our Healthcare division at Cofrac also handles the accreditation (non-mandatory) of your anatomy and cytopathology (ACP) and human biology structures. Its field of action may be extended in time to new technical medical procedures such as medical imaging.

See Cofrac document SH INF 50: Standard accreditation scopes

Reform of accreditation for biomedical laboratories

Since the medical analysis activity has such a major impact on public health, the French Public Healthcare Code (article L 6221-1) made accreditation of biomedical laboratories mandatory in 2009. This reform concerns both private and hospital biomedical labs.

31 December 2017 was the first deadline. By this date, biomedical laboratories had to fulfil two criteria: being accredited for each of the three families of examinations practised (biochemistry-genetics, immunology-haematology-reproductive biology, microbiology) and for at least 50% of their activity. The second deadline for the reform was set for 2020. By this date, all the activity of the laboratories must be accredited.

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