What is a Risk Management File?
ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”.
In practice, the risk management file must contain, or have reference to, the following documents:
1. (4.2, Note 3) The policy for establishing criteria for risk acceptability.
2. (4.4) The Risk Management Plan.
3. (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.
4. (5.1) The Risk analysis.
5. (5.2) Intended Use and Reasonably Foreseeable Misuse.
6. (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics.
7. (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).
8. (5.5) Risk Estimation.
9. (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
10. (6) Risk Evaluation.
11. (7.1) Risk Control Measures.
12. (7.2) Verification of Implementation of the Risk Control Measures.
13. (7.3) Evaluation of Residual Risk.
14. (7.4) the results of the Benefit-Risk Analysis.
15. (7.5) Risks arising from implemented risk control measures.
16. (7.6) Review of completeness of risk controls.
17. (8) Evaluation of Overall Residual Risk.
18. (9) Risk Management Report, including Risk Management Review.
19. (10.3) Results of the review of the post-production information.
20. (10.4) Decision arising from the review of post-production information.
1. | (4.2, Note 3) The policy for establishing criteria for risk acceptability. |
2. | (4.4) The Risk Management Plan. |
3. | (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks. |
4. | (5.1) The Risk analysis. |
5. | (5.2) Intended Use and Reasonably Foreseeable Misuse. |
6. | (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device. Where appropriate, the manufacturer shall define limits of those characteristics. |
7. | (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s). |
8. | (5.5) Risk Estimation. |
9. | (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm. |
11. | (7.1) Risk Control Measures. |
12. | (7.2) Verification of Implementation of the Risk Control Measures. |
13. | (7.3) Evaluation of Residual Risk. |
14. | (7.4) the results of the Benefit-Risk Analysis. |
15. | (7.5) Risks arising from implemented risk control measures. |
16. | (7.6) Review of completeness of risk controls. |
17. | (8) Evaluation of Overall Residual Risk. |
18. | (9) Risk Management Report, including Risk Management Review. |
19. | (10.3) Results of the review of the post-production information. |
20. | (10.4) Decision arising from the review of post-production information. |
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