EU-AIA-17-02
Documentation
17 — Quality management system
Document quality management system systematically
Description
Full Analysis & Evidence Requirements
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EU-AIA-17-01
Requirement
Establish quality management system for high-risk AI systems
EU-AIA-17-03
Requirement
Include regulatory compliance strategy in QMS
EU-AIA-17-04
Requirement
Include design techniques and procedures in QMS
EU-AIA-17-05
Requirement
Include development and quality control procedures in QMS
EU-AIA-17-06
Requirement
Include examination, test and validation procedures in QMS
EU-AIA-17-07
Requirement
Include technical specifications and standards in QMS
EU-AIA-17-08
Data Governance
Include comprehensive data management systems in QMS
EU-AIA-17-09
Risk Management
Include risk management system in QMS
EU-AIA-17-10
Monitoring
Include post-market monitoring system in QMS
EU-AIA-17-11
Reporting
Include serious incident reporting procedures in QMS
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