Risk Assessment Form
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
- Form
- Format
- DOCX
- Language
- English
- Tags
- Form, ISO 13485, Medical Devices
This form is used to carry out and record a risk assessment wherever the QMS requires risk-based decisions. ISO 13485:2016 requires a risk-based approach to the control of QMS processes (clause 4.1.2(b)), to outsourced processes and suppliers (clauses 4.1.5 and 7.4.1), to design changes (clause 7.3.9), to nonconforming product and corrective action (clauses 8.3 and 8.5.2), and to feedback (clause 8.2.1).
What's Inside
- Purpose and Instructions for Use
- When to use this form
- How to complete it
- Assessment Information
- Reason for Assessment
- Scope and Description
- Assessment Team
- Hazard Identification and Risk Estimation
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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