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Supplier Audits

White Paper: Supplier Audits- Keeping it Simple

An important part of a successful Quality Management System (QMS) is having a compliant Supplier Management Program. Purchasing Controls, including Supplier Management, are required within the Medical Device Industry, but are also relevant to many industries. Supplier Audits can be a large part of the Supplier Management Program; however, they become overwhelming. This White Paper focuses on requirements per 21 CFR 820.50, ISO 9001:2008 § 7.4, ISO 9001:2015 § 8.4, ISO 13485:2003 § 7.4, ISO 13485:2012 § 7.4 and ISO 13485:2016 § 7.4 and provides ideas for keeping Supplier Audits simple.

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