Compliance & AssessmentArticle 3(27)Article 40
Norma armonizada
Una norma europea elaborada por una organización europea de normalización reconocida (CEN, CENELEC o ETSI) a petición de la Comisión Europea; su cumplimiento genera una presunción de conformidad con los requisitos correspondientes del Reglamento.
Términos relacionados
- 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…
- CE MarkingThe marking by which a provider indicates that a high-risk AI system is in conformity with the requirements set out in Chapter III Section 2 of the…
- EU Declaration of ConformityA statement made by the provider affirming that a high-risk AI system is in conformity with the provisions of the Regulation and all applicable Union…
- Fundamental Rights Impact AssessmentA structured assessment required under Article 27 for deployers of high-risk AI systems that are bodies governed by public law, or private operators…
- Quality Management SystemA documented system that providers of high-risk AI systems must establish, implement, document, and maintain covering: the regulatory compliance strategy,…
- 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…
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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