EU-AIA-ANXVII-03
Reporting
VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation
Notify notified body of changes to QMS or covered AI systems list
Description
Full Analysis & Evidence Requirements
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EU-AIA-ANXVII-01
Documentation
Provider application content for QMS assessment
EU-AIA-ANXVII-02
Requirement
Maintain and implement approved quality management system
EU-AIA-ANXVII-04
Documentation
Lodge application for technical documentation assessment
EU-AIA-ANXVII-05
Documentation
Technical documentation application content requirements
EU-AIA-ANXVII-06
Data Governance
Grant notified body access to training, validation and testing datasets
EU-AIA-ANXVII-07
Conformity
Supply further evidence or conduct further tests upon request
EU-AIA-ANXVII-08
Data Governance
Grant access to training and trained models upon reasoned request
EU-AIA-ANXVII-09
Requirement
Retrain AI system before new conformity assessment application if data non-compliant
EU-AIA-ANXVII-10
Reporting
Inform notified body of changes affecting compliance or intended purpose
EU-AIA-ANXVII-11
Monitoring
Allow notified body access to premises for surveillance
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