Risk Management Procedure

This procedure defines the risk management process of your organisation for its medical devices throughout their life-cycle. ISO 13485:2016 clause 7.1 requires your organisation to document one or more processes for risk management in product realization and to keep records of risk management activities.

What's Inside

• Policy for Risk Acceptability
• Risk Management Plan
• Risk Management File
• Risk Analysis
• Risk Evaluation
• Risk Control
• Evaluation of Overall Residual Risk
• Risk Management Review and Report

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.