EU-AIA-ANXVII-16
Conformity
VII — Conformity based on an assessment of the quality management system and an assessment of the technical documentation
Notified body decision and certificate issuance/refusal for technical documentation
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-03
Reporting
Notify notified body of changes to QMS or covered AI systems list
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
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