ISO 13485
Document Change Request
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
- Request
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Request
This form is used to request, assess, approve, implement and close any new document, revision or withdrawal of a controlled QMS document.
What's Inside
- How to complete it
- Part A — Change Request
- Type of Request
- Reason for Change
- Description of Proposed Change
- Part B — Impact Assessment
- Change Classification
- Part C — Review and Approval
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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