Risk Control 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 single list of all risk control measures applied to the medical devices of your organisation. For each measure it records the hazard it controls, its type, where it is implemented in the design or process, the evidence that it has been implemented and is effective, the resulting residual risk, and how it is monitored in production and after release.
What's Inside
- Register Summary
- Risk Control Measures
- Verification and Residual Risk
- Monitoring of Risk Controls in Production and Post-Market
- Change Impact Check Log
- Register Change Log
- Review and Approval
- Review and sign-off section
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.1. 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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