Voluntary activity performed prior the formal assessment activities. ISO 13485 certification consists of several steps prior we are able to grant you certificate as a result of compliance with all applicable requirements of ISO 13485:2016 standard or other relevant regulations. supervised quality management system is right way how to ensure the consistence of design, production, delivery, installation through to disposal of medical devices and in vitro medical devices that are safe and meet performance claims for their intended purpose. The quality management standard ISO 13485:2016 was published to support medical device manufacturers, designers, suppliers and other interested organization in building, designing and implementing quality management systems in order to ensure sustainable effectiveness of their processes. In order to cover unique specification of medical device manufacturing as an industry sector which is thoroughly regulated and supervised, the ISO 13485 standard has been divided from the ISO 9001 in order to set specific medical device management system requirements on well known process based approach principles Plan, Do, Check and Act. It is a internationally recognized standard based on ISO 9000 standard series which is intended to be use by manufacturers, suppliers and other organizations in one or more stages of medical devices life-cycle and production chain. Medical device – Quality management system – Requirements for regulatory purpose – ISO 13485:2016
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