Certification ISO 9001 d’un système de management qualité dans un centre d’investigation clinique [ISO 9001certification of a quality management system in a clinical investigation center]

Résumé : Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article.
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Jimmy Chesnais, Claire Fougerou-Leurent, Claire Laforest, Alain Renault, Eric Bellissant, et al.. Certification ISO 9001 d’un système de management qualité dans un centre d’investigation clinique [ISO 9001certification of a quality management system in a clinical investigation center]. Thérapie, EDP Sciences, 2018, 73 (6), pp.521-527. ⟨10.1016/j.therap.2018.04.005⟩. ⟨hal-01807758⟩

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