ISO 13485
Document and Record Control Procedure
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
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- Standard
- ISO 13485
- Document Type
- Procedure
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Procedure
This procedure defines how your organisation controls the documents and records of its Quality Management System (QMS), as required by ISO 13485:2016 clauses 4.2.4 and 4.2.5.
What's Inside
- Control of Documents
- Document Hierarchy
- Document Identification and Numbering
- Format and Content
- Creating and Reviewing Documents
- Identifying Changes and Current Revision Status
- Changes to Documents
- Periodic Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.2.4 and 4.2.5. 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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