ISO 13485:2016 is that the commonplace for a top quality Management System ("QMS") for the planning and manufacture of Medical Devices. Certification to the quality needs associate degree organization's quality management system to pass a third-party Medical Device Single program, or "MDSAP" Audit. For the foremost part: ISO 13485 = ISO 9001 + further Medical Device necessities.
While ISO 13485:2016 remains a complete document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.) this can be as a result of it doesn't follow the high-level structure (Annex L) of the most recent version of ISO 9001 (which is 9001:2015). additionally, the documentation and safety necessities square measure a lot of larger underneath ISO 13485:2016, whereas ISO 9001:2015 puts target client satisfaction and continuous improvement.