SOP-RM-001 Risk Management Procedure

Purpose

Implement a risk management process across product lifecycle activities.

Standard

• ISO 14971 risk management principles are applied.

Process

1. Hazard identification
2. Risk estimation and evaluation
3. Risk control implementation
4. Verification of control effectiveness
5. Residual risk evaluation and benefit-risk conclusion
6. Production and post-production monitoring

Deliverables

• Risk Management Plan
• Risk Analysis Table
• Risk Control Verification Evidence
• Risk Management Report

Trigger Events

• New feature
• Safety incident
• Significant complaint trend
• Regulatory change