ISO 13485:2016 does not have the same high-level structure of most other ISO standards and revisions, including ISO 9001:2015.Instead, ISO 13485 only requires implementation and maintenance of the QMS. It also removes some requirements in ISO 9001, most notably those around demonstrating continuous improvement.ISO 13485 adds some requirements on top of ISO 9001, specifically around documentation and identifying regulatory requirements for manufactured devices.Some key differences companies should pay attention to: ISO 13485 incorporates (almost) all of ISO 9001, applying the Plan-Do-Check-Act approach to medical device manufacturing.
ISO 13485 is a standalone document based on its popular cousin, ISO 9001 for Quality Management Systems. What’s the Difference Between ISO 13485 and ISO 9001?