ISO 14971 Risk Management File Kit

Build an ISO 14971:2019 risk management file that reviewers can follow from plan to report, with the registers and workbooks for hazard analysis, risk evaluation and control, and the link to production and post-production information.

What's inside (15 files)

• Policy and Plan: Risk Management Plan; Risk Management Policy.
• Analysis, Evaluation and Control: Benefit-Risk Analysis Worksheet; Hazard Identification and Risk Analysis Registers; Overall Residual Risk Evaluation; Risk Evaluation and Control Workbook.
• File, Report and Production Information: Optional - Quality (Process) Risk Assessment; Production and Post-Production Information Review; Risk Management File Index and Traceability; Risk Management Report.
• Training: Risk Management training module (slides, trainer guide, workbook, assessment).

How to use it

1. Approve the risk management policy with your acceptability criteria.
2. Write the risk management plan for each device family.
3. Identify hazards and hazardous situations, estimate and evaluate risks, and record controls in the workbooks.
4. Verify each control, evaluate overall residual risk and document benefit-risk where needed.
5. Complete the report and keep reviewing production and post-production information.

Who it's for

Manufacturers building or repairing an ISO 14971 risk management file.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Also in the ISO 13485 Complete QMS Kit, which costs less than buying kits separately.