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A.P. Lyon
Supplier Management Procedure — editable word document cover

Supplier Management Procedure | ISO 13485 | FDA QMSR

$149.00Price

Use this editable medical device Supplier Management Procedure to select, evaluate, approve and monitor suppliers of products and services used in device design and manufacturing.


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Supplied as five editable Microsoft Word documents (the procedure, three forms and a controlled list document) in a digital download.


Supplier approval, monitoring and purchasing controls


The procedure connects initial qualification with risk-based classification, supplier audits, approval status and ongoing evaluation so purchased products and services can be assessed against specified requirements.


The procedure addresses the following:


  • Initial Supplier Selection

  • Supplier Self-Assessment

  • Supplier Survey

  • Critical Suppliers (Risk Based)

  • Supplier Audits

  • Supplier Status Assignment

  • Supplier Source Inspection

  • Annual Supplier Evaluation

  • Approved Supplier List (Includes ASL List Content and Management)


For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.


Related purchasing controls


Use the Purchase Order Procedure for purchase requirements and the Receiving and Identification of Materials Procedure for incoming materials. The CAPA Procedure addresses corrective action when supplier issues warrant it.


See the MANUFACTURING PLUS Quality Management System


Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.


Practical guide


Read Medical Device Supplier Management and Purchase Orders for workflow guidance, a checklist and common mistakes.

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