Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019
Executive Summary
Here’s a crosswalk for recently revised international risk management standard ISO 14971 and its 2007 predecessor.
Below is a crosswalk for the clauses and subclauses in the previous version (2007) of international risk management standard ISO 14971 and the new 2019 edition. (Check out our related ISO 14971:2019 story for tips on bringing the retooled standard into quality systems, and more.)
ISO 14971:2007 |
ISO 14971:2019 |
1 Scope |
1 Scope |
(New clause) |
2 Normative references |
2 Terms and definitions |
3 Terms and definitions |
2.1 accompanying documentation |
3.1 accompanying documentation |
(New definition) |
3.2 benefit |
2.2 harm |
3.3 harm |
2.3 hazard |
3.4 hazard |
2.4 hazardous situation |
3.5 hazardous situation |
2.5 intended use intended purpose |
3.6 intended use intended purpose |
2.6 in vitro diagnostic medical device IVD medical device |
3.7 in vitro diagnostic medical device IVD medical device |
2.7 life cycle |
3.8 life cycle |
2.8 manufacturer |
3.9 manufacturer |
2.9 medical device |
3.10 medical device |
2.10 objective evidence |
3.11 objective evidence |
2.11 post-production |
3.12 post-production |
2.12 procedure |
3.13 procedure |
2.13 process |
3.14 process |
(New definition) |
3.15 reasonably foreseeable misuse |
2.14 record |
3.16 record |
2.15 residual risk |
3.17 residual risk |
2.16 risk |
3.18 risk |
2.17 risk analysis |
3.19 risk analysis |
2.18 risk assessment |
3.20 risk assessment |
2.19 risk control |
3.21 risk control |
2.20 risk estimation |
3.22 risk estimation |
2.21 risk evaluation |
3.23 risk evaluation |
2.22 risk management |
3.24 risk management |
2.23 risk management file |
3.25 risk management file |
2.24 safety |
3.26 safety |
2.25 severity |
3.27 severity |
(New definition) |
3.28 state of the art |
2.26 top management |
3.29 top management |
2.27 use error |
3.30 use error |
2.28 verification |
3.31 verification |
3 General requirements for risk management |
4 General requirements for risk management system |
3.1 Risk management process |
4.1 Risk management process |
3.2 Management responsibilities |
4.2 Management responsibilities |
3.3 Qualification of personnel |
4.3 Competence of personnel |
3.4 Risk management plan |
4.4 Risk management plan |
3.5 Risk management file |
4.5 Risk management file |
4 Risk analysis |
5 Risk analysis |
4.1 Risk analysis process |
5.1 Risk analysis process |
4.2 Intended use and identification of characteristics related to the safety of the medical device |
5.2 Intended use and reasonably foreseeable misuse 5.3 Identification of characteristics related to safety |
4.3 Identification of hazards |
5.4 Identification of hazards and hazardous situations |
4.4 Estimation of the risk(s) for each hazardous situation |
5.5 Risk estimation |
5 Risk evaluation |
6 Risk evaluation |
6 Risk control |
7 Risk control |
6.1 Risk reduction |
(Subclause deleted) |
6.2 Risk control option analysis |
7.1 Risk control option analysis |
6.3 Implementation of risk control measure(s) |
7.2 Implementation of risk control measures |
6.4 Residual risk evaluation |
7.3 Residual risk evaluation |
6.5 Risk/benefit analysis |
7.4 Benefit-risk analysis |
6.6 Risks arising from risk control measures |
7.5 Risks arising from risk control measures |
6.7 Completeness of risk control |
7.6 Completeness of risk control |
7 Evaluation of overall residual risk acceptability |
8 Evaluation of overall residual risk |
8. Risk management report |
9 Risk management review |
9 Production and post-production information |
10 Production and post-production activities 10.1 General 10.2 Information collection 10.3 Information review 10.4 Actions |
Annex A Rationale for requirements |
Annex A Rationale for requirements |
Annex B Overview of the risk management process for medical devices |
Annex B Risk management process for medical devices |
Annex C Questions that can be used to identify medical device characteristics that could impact on safety |
Moved to ISO/TR 24971 |
Annex D Risk concepts applied to medical devices |
Moved to ISO/TR 24971 |
Annex E Examples of hazards, foreseeable sequences of events and hazardous situations |
Annex C Fundamental risk concepts |
Annex F Risk management plan |
Moved to ISO/TR 24971 |
Annex G Information on risk management techniques |
Moved to ISO/TR 24971 |
Annex H Guidance on risk management for in vitro diagnostic medical devices |
Moved to ISO/TR 24971 |
Annex I Guidance on risk analysis process for biological hazards |
Deleted |
Annex J Information for safety and information about residual risk |
Moved to ISO/TR 24971 |