This table aligns the sections of ISO 14971:2019 with the corresponding documents.
The document titles in the “Fulfilled in Document” column reflect the FdaToday templates. Your system for naming documents might differ, so adjustments can be made as needed.
ISO 14971:2019
| Section | Title | Document |
|---|---|---|
| 4.1 | Risk management process | SOP Integrated Software Development |
| 4.1.c | Risk controls | SOP Integrated Software Development, para. 3 Risk Table |
| 4.1.d | Effectiveness of risk control measures | SOP Integrated Software Development SOP Post-Market Surveillance Risk Table |
| 4.2 | Management responsibilities | Quality Manual SOP Human Resources Management SOP Management Review Risk Management Plan |
| 4.3 | Competence of personnel | SOP Human Resources Management Training Matrix |
| 4.4 | Risk management plan | Risk Management Plan |
| 4.5 | Risk management file | Risk Table |
| 5.1 | Risk analysis process | SOP Integrated Software Development, para. 2, 3 and 10 |
| 5.2 | Intended use and reasonably foreseeable misuse | SOP Integrated Software Development, para. 2, 3 and 10 Intended Use Risk Table |
| 5.3 | Safety characteristics | SOP Integrated Software Development, para. 1-3 Risk Table |
| 5.4 | Hazards and hazardous situations | SOP Integrated Software Development, para. 3 Risk Table |
| 5.5 | Risk estimation | SOP Integrated Software Development, para. 2 and 3 Risk Table |
| 6 | Risk evaluation | SOP Integrated Software Development, para. 2 and 3 Risk Table |
| 7.1 | Risk control option analysis | SOP Integrated Software Development, para. 3 Risk Table |
| 7.2 | Implementation of risk control measures | SOP Integrated Software Development, para. 6 Risk Table |
| 7.3 | Residual risk evaluation | SOP Integrated Software Development, para. 10 Risk Management Report |
| 7.4 | Benefit-risk analysis | SOP Integrated Software Development, para. 10 Risk Management Report |
| 7.5 | Risks from risk control measures | SOP Integrated Software Development, para. 10 Risk Management Report |
| 7.6 | Completeness of risk control | SOP Integrated Software Development, para. 3 Risk Management Report |
| 8 | Overall residual risk evaluation | SOP Integrated Software Development, para. 10 Risk Management Report |
| 9 | Risk management review | SOP Integrated Software Development, para. 10 Risk Management Report |
| 10.1 | Production and post-production activities | SOP Post-Market Surveillance |
| 10.2 | Information collection | SOP Post-Market Surveillance, para. 2 |
| 10.3 | Information review | SOP Post-Market Surveillance, para 2 and 3 |
| 10.4 | Actions | SOP Post-Market Surveillance, para 2 and 3 |