QM-007AltoProveedorPreventivo
Plan de seguimiento poscomercialización
El artículo 17, apartado 1, letra f), exige a los proveedores aplicar un plan de seguimiento poscomercialización que especifique los datos que deben recogerse, la frecuencia del seguimiento, los umbrales de rendimiento y los mecanismos de retroalimentación para integrar las conclusiones operativas.
Artículos:Article 17(1)(f)Article 72
Ejemplos de evidencia
- Post-market monitoring plan document
- Monitoring KPI definitions
- Data collection mechanism description
Normas
ISO 42001:2023 §9.1Annex VII EU AI Act
Controles relacionados
- QM-001Quality Management System EstablishmentArticle 17(1) requires providers of high-risk AI systems to put in place a quality management system that ensures compliance with the requirements of the…
- QM-002Regulatory Compliance StrategyProviders must establish and document a strategy for achieving and maintaining compliance with applicable regulatory requirements, including the EU AI…
- QM-003Design Control ProceduresProviders must implement documented design control procedures that ensure regulatory and performance requirements are systematically incorporated from the…
- QM-004Data Management ProceduresProviders must have documented data management procedures covering the acquisition, preparation, use, and retention of data throughout the AI system…
- QM-005Staff Training and Competency ProceduresArticle 17(1)(d) requires providers to implement procedures for training personnel involved in AI system development, testing, and monitoring, with…
- QM-006Pre-Market Testing and Validation ProceduresProviders must implement documented procedures for pre-market testing and validation of high-risk AI systems, including the metrics to be achieved, the…
Términos relacionados de la Ley de IA
- Quality Management SystemA documented system that providers of high-risk AI systems must establish, implement, document, and maintain covering: the regulatory compliance strategy, design and development processes, data governance procedures, risk management, post-market monitoring, and incident reporting.
- Post-Market MonitoringProactive collection and review of experience gained from the use of high-risk AI systems, to identify any need for corrective or preventive actions and ensure continued compliance throughout the system lifecycle.
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