Supplier Management Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Supplier Management Procedure governs the review, approval and continuous monitoring of all suppliers to ensure conformance to regulatory requirements.

• Includes Related Forms

• MS Word Format

• Digital Content - Instant Download

Supplier Management Procedure - Overview

The Supplier Management Procedure ensures that suppliers of purchased or otherwise received product and services intended for use in the design and manufacture of finished medical devices conform to 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)

Regulatory framework

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.