CA-008AltoFornitorePreventivo
Preparazione del fascicolo tecnico per la valutazione
I fornitori devono preparare un fascicolo tecnico completo comprendente tutta la documentazione tecnica richiesta dagli articoli 11 e dall'allegato IV, organizzato per supportare un riesame efficiente da parte delle autorità di vigilanza del mercato o degli organismi notificati.
Articoli:Article 11(1)Article 43(1)Annex IV
Esempi di prove
- Technical file completeness checklist
- Annex IV structure compliance
- Technical file version control record
Norme
Annex IV EU AI Act
Controlli correlati
- CA-001Conformity Assessment Pathway SelectionArticle 43 requires providers to select the appropriate conformity assessment procedure for their high-risk AI system: internal control (Annex VI) under…
- CA-002Internal Control Assessment (Annex VI)For AI systems subject to internal control assessment, providers must verify and document that the system meets all applicable requirements of Articles…
- CA-003Third-Party Notified Body AssessmentThird-party assessment is the exception. It applies to Annex III point 1 biometric identification and categorisation systems under Article 43(1) where…
- CA-004CE Marking AffixationArticle 48 requires that providers affix the CE marking to high-risk AI systems that have successfully completed conformity assessment, certifying that…
- CA-005EU Declaration of ConformityArticle 47 requires providers to draw up an EU Declaration of Conformity for each high-risk AI system, declaring that it meets all applicable…
- CA-006Notified Body Selection and EngagementWhere third-party assessment is required, providers must select a notified body that is duly designated for the relevant Annex III category, verify its…
Termini correlati del Regolamento 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).
- Technical DocumentationThe documentation that providers of high-risk AI systems must draw up before placing the system on the market, containing all necessary information to assess compliance with the Regulation, including a general description, design specifications, training data information, risk management records, and performance metrics. Content requirements are set out in Annex IV.
Passa alla versione completa quando la conformità deve essere
Il questionario gratuito fornisce segnali preliminari. La Valutazione Completa trasforma i dati reali di sistema in un fascicolo decisionale governato: estrazione, separazione componenti, prove, sovrapposizioni nazionali e dossier pronto per audit.
Avvia anteprima gratuita del rischio