CROSSWALK
ISO 14971 Risk Management Crosswalk
ISO 14971 risk management, step by step — hazard analysis through residual-risk evaluation — cross-referenced to ISO 13485 and the FDA QMSR, with the points the scanner evaluates.
Group by:
Design & Development
| ISO 14971 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §4.1 | 7.1 | Risk Management Process | 3 | View → |
| §4.4 | 7.1 | Risk Management Plan | 2 | View → |
| §5.2 | 7.3.3 | Intended Use and Reasonably Foreseeable Misuse | 1 | View → |
| §5.4, 5.5 | 7.1 | Hazard Identification and Risk Estimation | 2 | View → |
| §6 | 7.1 | Risk Evaluation Against Acceptability Criteria | 1 | View → |
| §7.1, 7.2 | 7.3.3 | Risk Control Option Analysis | 2 | View → |
| §7.3, 7.4 | 7.1 | Residual Risk Evaluation and Benefit-Risk Analysis | 2 | View → |
Management Oversight
| ISO 14971 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §8, 9 | 7.1 | Overall Residual Risk Evaluation and Risk Management Review | 1 | View → |
Measurement, Analysis & Improvement
| ISO 14971 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §10 | 8.2.1 | Production and Post-Production Information Review | 2 | View → |
Other standards
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