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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.
This international commonplace is obligatory in some countries, and within the U.S. the authority has planned a rule which might harmonize U.S. authority twenty one CFR 820 with ISO 13485:2016, creating ISO 13485 the FDA’s obligatory QMS for Medical Devices (the rule is predicted to be discharged in 2019).
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