PM-006AltoFornitoreCorrettivo
Procedure di azioni correttive
I fornitori devono attuare procedure documentate di azioni correttive che specifichino come vengono affrontati i problemi di prestazione, gli incidenti e le non conformità identificati, inclusi indagine, determinazione delle azioni, attuazione e verifica dell'efficacia.
Articoli:Article 20(1)Article 72(2)
Esempi di prove
- Corrective action SOP
- CAPA log with status tracking
- Effectiveness verification records
Norme
ISO 42001:2023 §10.1ISO 9001:2015 §10.2
Controlli correlati
- PM-001Post-Market Monitoring Plan EstablishmentArticle 72(3) requires providers to establish, document, and implement a post-market monitoring plan that proportionately reflects the nature of the AI…
- PM-002Operational Data Collection SystemProviders must implement a system for collecting and analysing relevant data on the performance of high-risk AI systems throughout their operational…
- PM-003In-Operation Performance TrackingProviders must continuously track performance indicators in operation, comparing actual performance against the baseline established during pre-market…
- PM-004Incident Detection and Root Cause AnalysisProviders must implement automated and manual mechanisms to detect incidents and near-misses in operation, and conduct root cause analysis for significant…
- PM-005Serious Incident Reporting to AuthoritiesArticle 73(1) requires providers and deployers to report serious incidents to the relevant market surveillance authority without undue delay after…
- PM-007Feedback Integration from DeployersProviders must establish channels for receiving and systematically processing feedback from deployers about AI system performance, incidents, and…
Termini correlati del Regolamento IA
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