ISO 13485
Identification and Traceability 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 identifies product and its status throughout product realization, assigns and maintains Unique Device Identification (UDI), and keeps traceability records.
What's Inside
- Product Identification Throughout Realization
- Numbering Conventions
- Inspection and Test Status
- Identification of Returned Product
- Unique Device Identification (UDI)
- Traceability (7.5.9.1)
- Distribution Records and the Supply Chain
- Traceability Exercises (Mock Recalls)
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.5.8 and 7.5.9. 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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