Therefore, ISO 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements. While being certified to ISO 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) as well as many other regulatory requirements found globally. About ISO 13485 Quality Management System (QMS) for Medical. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. Take your business to greater heights by implementing the worlds most widely-used standard. The 2016 version of ISO 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. Though based on ISO 9001, ISO 13485 does not fulfill the requirements of 9001. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Iso13485201628en29.pdf - 13485 Third edition Reference number ISO 13485:2016(E) Licensed to Red Star Contract Mfg / Barry Leffers. ISO 13485:2016 represents the requirements that medical device manufacturers must incorporate into their management systems.
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