ISO 13485:2016 is that the commonplace for a fine quality Management System (“QMS”) for the design and manufacture of Medical Devices. Certification to the standard wants associate 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 + more Medical Device requirements. While ISO 13485:2016 remains a whole document, it aligns with ISO 9001:2008. (Yes, 2008, not 2015.) this may be as a results of it does not follow the high-level structure (Annex L) of the foremost recent version of ISO 9001 (which is 9001:2015). in addition, the documentation and safety requirements unit loads of larger beneath ISO 13485:2016, whereas ISO 9001:2015 puts target consumer satisfaction and continuous improvement.

ISO 13485:2016 is obligatory in some countries, and inside the U.S. the authority has planned a rule which could harmonize U.S. authority twenty one CFR 820 with ISO 13485:2016, making ISO 13485 the FDA’s obligatory QMS for Medical Devices (the rule is foretold to be discharged in 2019).