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ISO 13485:2016 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Though based on ISO 9001, ISO 13485 does not fulfill the requirements of 9001. The 2016 version of ISO 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. 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.

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. 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.

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