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Article 69 of the Hospitals, Patients, Health, Territories (HPST) Act, passed in summer 2009 (law of 21 July 2009 published in the OJ on 22 July 2009), renders compulsory and total (for all examination activities) the accreditation of medical biology laboratories (LBM) in order to “provide better guarantees on the quality of medical biology examinations, in particular by setting up a procedure for the accreditation of laboratories”.
It is for this purpose that the Healthcare section was created at Cofrac in October 2009, dedicated essentially, at least initially, to the accreditation of LBMs based on the standard NF EN ISO 15189.
As of 1 January 2010, the Section is legally empowered to receive accreditation requests, still on a voluntary basis, for all or part of the activity of LBMs, pending publication in the OJ of the legislative ordinance organising medical biology and the statutory implementing texts (Orders, Decrees, etc.). The first accreditations will begin on a statutory basis in the course of 2010.