ISO 9001 & ISO 13485 - Integrated Quality Management System

ISO 9001 & ISO 13485 - Integrated Quality Management System

Because ISO 13485:2016 has a differing structure from ISO 9001:2015, the new medical standard no longer completely encompasses 9001, and organizations wishing to conform to both must address the requirements separately.

There is a way to rearrange these requirements and make the two standards work together in a single quality management system and manual, and we can help you achieve this goal.

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