This Supplier Quality Management procedure is updated to the most recent requirements for ISO 13485:2016, Clause 7.4 compliance and for compliance with 21 CFR 820.50.
Supplier Quality Management Procedure Contents
This Supplier Quality Management procedure is written with the intent to meet the regulatory requirements for ISO 13485:2016, Clause 7.4 and 21 CFR 820.50. The procedure is 11 pages in length. The procedure also references the following forms that are included if you purchase the procedure:
- Supplier Quality Management (SYS-011)
- Approved Supplier List (LST-003)
- Supplier Evaluation Report Template (TMP-002)
- Supplier-Internal Audit Report Template (TMP-003)
- New Supplier Approval Request Form (FRM-005)
- Supplier Nonconformity Report Form (FRM-006)
- Supplier Nonconformity Report (SNCR) Register (LST-004)
Buying Our Supplier Quality Management SOP
This procedure package includes 7 documents
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Purchasing Procedure Scope
This procedure covers the quality management of suppliers. When partnering with suppliers, commercial and quality aspects impact on each other. This document covers only the specific quality aspects of that relationship.
How to write your own supplier quality management procedure…
Mary Vater, one of our regulatory consultants, wrote a blog about supplier quality and purchasing controls. You can follow her guidance and other articles we have written for writing procedures in general.
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