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 Procedures/Forms (SYS-011) and Webinar Bundle
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.
What you will receive
Document control lists and forms are also included within this procedure. These documents are updated for the US FDA Quality System Regulation (QMSR), ISO 13485:2016, and the new European Regulations. The following is a list of documents included:
- SYS-011 v0.10 Supplier Quality Management
- TMP-003 v0.5 Supplier-Internal Audit Report Template
- TMP-002 v0.1 Supplier Evaluation Report Template
- SYS-011 Supplier Quality Management Training 4-15-2024
- Quality Agreement Table
- LST-008 v0.1 Nonconformity Report Register
- LST-003 v0.3 Approved Supplier List
- FRM-037 v0.1 Supplier Quality Agreement
- FRM-008 v0.4 Nonconformity Report (NCR)
- FRM-005 v0.1 New Supplier Approval Request Form
- FRM-004 v0.1 Supplier Questionnaire
If you would like to ask specific questions about the document control procedure and process, please submit them via email or schedule a call using the calendar app on our contact us page. All content deliveries will be sent via AWeber emails to confirmed subscribers. Please check your spam folder if you don’t receive the content automatically.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
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About Your Instructor
Rob 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. Rob 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 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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 at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.