ISO 13485

Supplier Audit Report

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
Report
Format
DOCX
Language
English
Tags
ISO 13485, Medical Devices, Report

This report records the results of an audit of a supplier or outsourced-process provider. Supplier audits are one of the methods used to evaluate, select, monitor and re-evaluate suppliers under ISO 13485:2016 clause 7.4.1, and to apply controls to outsourced processes proportionate to the risk involved (clause 4.1.5).

What's Inside

  • Audit Details
  • Objectives, Scope and Criteria
  • Executive Summary
  • Areas Audited and Results
  • Findings
  • Strengths
  • Follow-Up of Previous Audit Findings
  • Effect on Supplier Status and Actions

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