The international standard iso 13485:2016 defines criteria for a quality management system for medical device manufacturing;

Iso 13485 version 2016 pdf. The last major revision of this quality management system standard happened back. A summary of the changes incorporated into this edition compared with the previous edition is given in annex a. L'iso 13485:2016 énonce les exigences relatives au système de management de la qualité lorsqu'un organisme doit démontrer son aptitude à fournir régulièrement des dispositifs médicaux et des services associés conformes aux exigences des.

This document explains each clause of iso 13485:2016 in plain english to help you better understand the requirements of the standard. Iso 13485 version 2016 pdf free download. Elle s’intéresse par conséquent aux risques associés à la sécurité et à la performance des dispositifs médicaux, et à la conformité aux exigences réglementaires.

This international standard is based on a process approach to quality management. Ne pensez pas que vous pouvez terminer ce quiz. The checklist is best used by trained and practicing auditors to evaluate or assess quality management systems requirements based on the standard.

2016 » laurine beuzelin, amaury desgranges, quentin emile technologies et territoires de santé Iso 13485:2016(e) 0.2 clarification of concepts in this international standard, the following terms or phrases are used in the context described below. This white paper is designed to help top.

Présentation des différents article de la norme iso 13485 : A requirement is considered appropriate if it is necessary for: New versions of iso 13485 and iso 9001, what do you need to consider.

Download white paper | pdf how to budget an iso 13485 implementation project Over the next three years, iso 13485:2003 Iso 13485 derived from iso 9001, a quality management standard that is available to businesses in a wide variety of industries.