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 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 7 documents
Are you planning to buy this procedure?
After your transaction is verified automatically by PayPal, you will receive a subscriber verification email at the email address provided in the shopping cart transaction. The purpose of this is to verify that you would like free email updates when this procedure is updated in the future for continued regulatory compliance. If you do not receive that email, please check your spam folder. Since 50% of these emails are filtered out, we will also send a manual email to you personally to make sure that you receive the content you purchased.
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.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: