ISO 13485
Document Review Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents the review of a controlled QMS document. ISO 13485:2016 clause 4.2.4 requires your organisation to review and approve documents for adequacy before issue (a), and to review, update as necessary and re-approve them (b).
What's Inside
- Types of review
- How to complete it
- Part A — Review Details
- Part B — Review Checklist
- Part C — Findings and Comments
- Part D — Review Outcome
- Periodic Review Schedule
- Review Log
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 4.2.4. 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
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