ISO 13485
Control of Nonconforming Product 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 ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery, as required by ISO 13485:2016 clause 8.3.
What's Inside
- Responsibilities and Authorities
- Identification and Segregation
- Documentation
- Containment
- Evaluation
- Disposition Before Delivery
- Concessions
- Rework
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 8.3. 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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