ISO 13485

Approved Supplier Register

Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.

Fully Customizable Audit Ready Instant Download
Standard
ISO 13485
Document Type
Register
Format
DOCX
Language
English
Tags
ISO 13485, Medical Devices, Register

This register lists every supplier approved by your organisation to provide products or services that affect the quality of its medical devices, including outsourced processes. For each supplier it records the approved scope, supplier class, approval status, certification, quality agreement, performance and re-evaluation dates.

What's Inside

  • Register Summary
  • Approved Supplier List
  • Outsourced Processes and Critical Suppliers
  • Performance Monitoring
  • Certificates and Audit Schedule
  • Status Change Log
  • Disqualified and Inactive Suppliers
  • Review and Approval

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 4.1.5 and 7.4.1. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.

Key Benefits

  • Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements