This Supplier Quality Management procedure (SYS-011) is compliant with ISO 13485:2016, 21 CFR 820.50, SOR 98/282, and EU MDR 2017/745.
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 Quality Agreement (FRM-037)
- Supplier Nonconformity Report (SNCR) Register (LST-004)
Buying Our Supplier Quality Management SOP
SYS-011 Supplier Quality Management Procedures/Forms – This procedure package includes 8 documents. The procedure is compliant with ISO 13485:2016 and 21 CFR 820.50. The procedure also meets the requirements of the Canadian Medical Devices Regulation (SOR 98/282) and the European Medical Device Regulation (2017/745).
Are you planning to buy this procedure?
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Purchasing Procedure Scope
This procedure covers the quality management of suppliers. When partnering with suppliers, commercial and quality aspects impact 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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About the Author
Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.