Nonconforming Product Register
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Register
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Register
This register is the master list of all nonconformance reports (NCRs) for product and materials. ISO 13485:2016 clause 8.3.1 requires records of the nature of nonconformities and any subsequent action taken, including evaluation, any investigation and the rationale for decisions.
What's Inside
- Register Status Summary
- Concession Register
- Nonconforming Product Detected After Delivery
- Rework Register
- Scrap and Supplier Returns
- Analysis
- Register Review
- Review and sign-off section
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 8.3.1, 8.3.2 and 8.3.4. 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
Reviews
There are no reviews yet.