ISO 13485
Corrective Action Request
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
- Request
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Request
This request initiates, documents and closes a corrective action to eliminate the cause of nonconformities and prevent recurrence. ISO 13485:2016 clause 8.5.2 requires corrective action to be taken without undue delay and to be proportionate to the effects of the nonconformities.
What's Inside
- Request Details
- Problem Description
- Linked Nonconformities
- Containment and Correction
- Investigation and Root Cause
- Cause-and-Effect Review
- Five Whys — NC-27-034
- Evaluation of Need for Action
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 8.5.2. 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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