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ISO 13485:2016
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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