Risk Management Plan

A Risk Management Plan template defining how risk management will be carried out for a device or device family throughout its life cycle, in line with ISO 14971:2019 (clause 4.4 content requirements) and ISO 13485:2016, Clauses 4.1.2 and 7.1. It covers the device description and intended use, life-cycle phases, responsibilities, activities and schedule, risk analysis methods, risk acceptability criteria and verification of risk controls, and is the first document in the Risk Management File. It comes with a completed worked example.

What's Inside

• Device Description and Intended Use
• Life-Cycle Phases Covered
• Responsibilities and Authorities
• Risk Management Activities and Schedule
• Risk Analysis Methods
• Risk Acceptability Criteria
• When Probability Cannot Be Estimated
• Risk Control and Verification

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 4.1.2 and 7.1, and the risk management plan requirements of ISO 14971:2019. 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.