ISO 13485
Preventive Action 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 potential nonconformities and takes action to eliminate their causes in order to prevent their occurrence, as required by ISO 13485:2016 clause 8.5.3. Preventive actions are proportionate to the effects of the potential problems.
What's Inside
- Sources of Potential Nonconformities
- a) Determining Potential Nonconformities and Their Causes
- b) Evaluating the Need for Action
- c) Planning, Documenting and Implementing Action
- e) Reviewing Effectiveness
- Horizontal Deployment
- Records and Closure
- Monitoring and Management Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 8.5.3. 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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