Supplier Management Procedure | ISO 13485 | FDA QSR Compliant

$149.00
$149.00
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The ISO 13485 Supplier Management Procedure governs the review, approval and continuous monitoring of all suppliers to ensure conformance to regulatory requirements. 
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 7-006

ISO 13485 Supplier Management Procedure

The Supplier Management Procedure is an ISO 13485:2016 and FDA QSR compliant process of ensuring suppliers of products, components and services, at all risk levels, conform to your company's specifications and regulatory requirements.

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)

Supplier Management Procedure - Compliance

The Supplier Management Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 compliant.
To learn more about our Supplier Management Procedure contact us at [email protected]

RELATED LINKS

Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Supplier Management Procedure
Supplier Management Procedure

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