Étude d’un projet de certification selon l’ISO 13485 : intégration d’une démarche qualité globale

Abstract : Quality has evolved together with the modernization of production and is now an essential criterion for products or services offered on the market. The medical sector is particularly sensitive to the need to establish elements that control risk patient. New circumstances led European policy to harmonize practices and ensure a level of safety equivalent throughout the European community. It is in this dynamic that appears to ISO 13485 management systems allow companies to meet the requirements of European directives. It allows to combine safety and performance of the company. Within a company undergoing industrial seeking to certify according to ISO 13485, we conducted this study to measure the impact that could have on the process of certification quality system of the company. The implementation of the latter will be conditioned by the tools used. In addition, the deployment of principles necessary to the quality approach will be analyzed during the discussion.
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Master Thesis
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Michel Perrier. Étude d’un projet de certification selon l’ISO 13485 : intégration d’une démarche qualité globale. Sciences pharmaceutiques. 2013. ⟨dumas-01958886⟩

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