Subsection 1: Accreditation procedures for opening a medical biology laboratory

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…

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.

The laboratory assessment visit for accreditation by the French Accreditation Committee takes place no later than eight weeks after the actual opening of the medical biology laboratory.

The French Accreditation Committee shall notify the laboratory of the accreditation decision no later than twenty weeks after the actual opening of the laboratory. Within the same time limit, the French Accreditation Committee shall send this accreditation decision to the bodies mentioned in Article L. 6221-6. If the French Accreditation Committee does not respond within twenty weeks of the actual opening of the laboratory, the application for accreditation is deemed…