| AI Impact Assessment | Art. 9(1)Has the organisation established, implemented, documented and maintained a risk management system for high-risk AI systems throughout their lifecycle? Art. 9(2)(a)Are known and reasonably foreseeable risks identified, analysed and estimated for each high-risk AI system? Art. 9(9)Are impacts on children, vulnerable groups and persons with disabilities specifically assessed in the risk management process? | A.5.2AI system impact assessment process A.5.3Documentation of AI system impact assessments A.5.4Assessing AI system impact on individuals or groups of individuals |
| AI System Requirements | Art. 15(1)Are high-risk AI systems designed and developed to achieve an appropriate level of accuracy, robustness and cybersecurity throughout their lifecycle? Art. 15(3)Is the AI system resilient to errors, faults, or inconsistencies that may occur within the system or its operating environment? | A.6.2.2AI system requirements and specification |
| AI Design & Development Documentation | Annex IV(2)Are the design specifications, general logic, algorithms, key design choices, and classification methodology documented? | A.6.2.3Documentation of AI system design and development |
| AI Verification & Validation | Art. 9(5)–(7)Is the AI system tested to identify appropriate risk management measures and ensure consistent performance? Annex IV(3)Are performance metrics, validation and testing procedures, and their results documented with clearly defined and explained metrics? | A.6.2.4AI system verification and validation |
| AI Technical Documentation | Art. 11(1)Is technical documentation drawn up before the AI system is placed on the market or put into service, and kept up to date? Annex IV(1)Does the technical documentation contain a general description of the AI system including intended purpose, developer identity, version, and how it interacts with hardware/software? Art. 11(2)Is the documentation maintained in a format suitable for assessment by conformity assessment bodies and market surveillance authorities? | A.6.2.7AI system technical documentation |
| AI Event Logging | Art. 12(1)Are high-risk AI systems designed and developed with capabilities enabling automatic recording of events (logs) throughout the system's lifetime? Art. 12(2)Do logging capabilities enable monitoring of the system's operation with respect to the occurrence of situations that may result in risks to health, safety, or fundamental rights? | A.6.2.8AI system recording of event logs |
| AI Data Governance | Art. 10(2)Are training, validation and testing datasets subject to appropriate data governance and management practices? | A.7.2Data for development and enhancement of AI systems A.7.6Data preparation |
| AI Data Quality | Art. 10(3)Are datasets relevant, sufficiently representative, and to the best extent possible free of errors and complete in view of the intended purpose? | A.7.4Quality of data for AI systems |
| AI Data Provenance | Art. 10(2)(c)Is the provenance, origin, and legal basis of all training datasets documented and traceable? | A.7.3Acquisition of data A.7.5Data provenance |
| Information for AI System Users | Art. 13(1)Are high-risk AI systems designed and developed to ensure their operation is sufficiently transparent to enable deployers to interpret output and use it appropriately? Art. 13(3)(a)–(b)Are instructions of use provided with each high-risk AI system, including the provider's identity, system characteristics, capabilities, and limitations of performance? Art. 13(3)(b)(ii)Do instructions clearly describe the level of accuracy, robustness and cybersecurity against which the system has been tested, and any known limitations? | A.8.2System documentation and information for users |