ISO 13485

Management Review Procedure

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

This procedure defines how the Top Management of your organisation reviews the Quality Management System (QMS) at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness, as required by ISO 13485:2016 clause 5.6.

What's Inside

  • Frequency, Scheduling and Extraordinary Reviews
  • Participants
  • Preparation and Agenda
  • Review Inputs
  • Conducting the Review
  • Conclusion on the QMS
  • Review Outputs
  • Minutes and Records

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 5.6. 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