ISO 13485
Final Product Inspection Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents the final inspection of a finished, sterilized lot and the review of its Device History Record before release for distribution.
What's Inside
- Purpose and Summary
- Lot Identification
- Sampling Plan SP-FI-01
- Physical Inspection Results
- Label and UDI Verification
- Shipper Carton Inspection
- Sterilization Release
- Device History Record Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.5.1, 7.5.7 and 8.2.6. 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
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