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Article R6213-22 of the French Public Health Code

The Commission nationale de biologie médicale shall set up a monitoring committee responsible for analysing the annual summary published by the Agence nationale de sécurité du médicament et des produits de santé of the reports produced by the external quality assessment bodies referred to in Article L. 6221-9 and for proposing any measures intended to improve the accreditation and quality control procedures for medical laboratories. This monitoring committee includes in…

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Article R6213-23 of the French Public Health Code

The Chairman of the Committee may : 1° Propose, after hearing the interested party, that a member who has been absent without justified reason from more than three consecutive meetings be replaced by a person appointed under the same conditions and for the remainder of the term of office; 2° Set up working groups to deal with any issues submitted to the Committee; 3° Entrust members of the Committee with…

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Article D6214-1 of the French Public Health Code

The declaration referred to in Article D. 6211-14 is sent, for medical biology laboratories under the authority of the Minister for Defence and appearing on the list provided for in II of Article L. 6147-7, to the Minister for Defence and to the Director General of the Regional Health Agency concerned.

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Article R6221-1 of the French Public Health Code

I.-The French Accreditation Committee shall make the information form and the self-assessment questionnaire available on its website. No later than sixteen weeks before its planned opening date, the medical biology laboratory shall send the French Accreditation Committee, by electronic means or by post with acknowledgement of receipt, its application for accreditation together with a complete file containing the information form, the self-assessment questionnaire, the quality manual and the main procedures…

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Article R6221-2 of the French Public Health Code

The laboratory must actually open within four weeks of notification of the provisional certificate referred to in 4° of III of Article R. 6221-1. Once this period has elapsed, the provisional certificate lapses. As from the actual opening of the laboratory, the provisional attestation is valid until the accreditation decision and for a maximum of twenty weeks.

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