Risk Management Report
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
- Report
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Report
A Risk Management Report template for recording the review carried out before a device is released for commercial distribution, confirming that the risk management plan has been implemented, overall residual risk is acceptable and methods are in place to collect production and post-production information. It comes with a completed worked example.
What's Inside
- Review Team and Meeting
- Implementation of the Risk Management Plan
- Risk Analysis and Evaluation Summary
- Risk Control Summary
- Residual Risk Evaluation
- Overall Residual Risk
- Disclosure of Residual Risks
- Production and Post-Production Information
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.2.3, 7.1, 7.3.5 and 7.3.8. 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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