RK-010AltoProveedorPreventivo
Pista de auditoría para la evaluación de la conformidad
Los proveedores deben mantener una pista de auditoría completa de cada evaluación de la conformidad, incluida toda la documentación revisada, pruebas realizadas, resultados obtenidos y decisiones adoptadas, para respaldar el escrutinio regulatorio y las reevaluaciones.
Artículos:Article 12(2)Article 43(1)
Ejemplos de evidencia
- Conformity assessment audit file
- Assessment decision record
- Notified body correspondence archive
Normas
ISO 42001:2023 §9.1Annex VI EU AI Act
Controles relacionados
- RK-001Automatic Event Logging CapabilityArticle 12(1) requires that high-risk AI systems are designed and developed with automatic logging capabilities, enabling the reconstruction of events…
- RK-002Log Integrity and Tamper ProtectionProviders must ensure that logs are protected against tampering, unauthorised deletion, or modification, using cryptographic integrity controls,…
- RK-003Log Retention for Minimum 10 YearsArticle 18(1) requires that providers retain technical documentation and logs for at least 10 years after the high-risk AI system is placed on the market…
- RK-004Log Accessibility for Competent AuthoritiesProviders must ensure that event logs are accessible to competent national authorities and market surveillance authorities upon request, with procedures…
- RK-005Event Traceability and ReconstructionLogs must enable the tracing and reconstruction of decision events to understand the inputs processed, the outputs generated, and the conditions under…
- RK-006Performance and Operational Metrics LoggingProviders must log performance and operational metrics relevant to verifying that the AI system operates within the parameters established in the…
Términos relacionados de la Ley de IA
- Conformity AssessmentThe process of verifying whether a high-risk AI system complies with the requirements set out in Chapter III Section 2 of the Regulation. Can be conducted through internal control (Annex VI) or with involvement of a notified body (Annex VII).
- Logging CapabilitiesThe automatic recording of events by a high-risk AI system during its operation — required under Article 12 to enable monitoring of its operation, post-hoc investigation of incidents, and to support the post-market monitoring obligations of providers and deployers.
Actualice cuando la conformidad deba ser
El cuestionario gratuito ofrece señales preliminares. La Evaluación Completa convierte la documentación real del sistema en un expediente de decisión auditable: extracción, separación de componentes, evidencias, normativas nacionales y dossier listo para auditoría.
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