QM-001CriticalProviderPreventive
Quality Management System Establishment
Article 17(1) requires providers of high-risk AI systems to put in place a quality management system that ensures compliance with the requirements of the EU AI Act, documented in policies, procedures, and instructions.
Articles:Article 17(1)
Evidence Examples
- QMS policy document
- Documented QMS scope statement
- QMS certification (ISO 42001 or equivalent)
Standards
ISO 42001:2023ISO 9001:2015
Related controls
- QM-002Regulatory Compliance StrategyProviders must establish and document a strategy for achieving and maintaining compliance with applicable regulatory requirements, including the EU AI…
- QM-003Design Control ProceduresProviders must implement documented design control procedures that ensure regulatory and performance requirements are systematically incorporated from the…
- QM-004Data Management ProceduresProviders must have documented data management procedures covering the acquisition, preparation, use, and retention of data throughout the AI system…
- QM-005Staff Training and Competency ProceduresArticle 17(1)(d) requires providers to implement procedures for training personnel involved in AI system development, testing, and monitoring, with…
- QM-006Pre-Market Testing and Validation ProceduresProviders must implement documented procedures for pre-market testing and validation of high-risk AI systems, including the metrics to be achieved, the…
- QM-007Post-Market Monitoring PlanArticle 17(1)(f) requires providers to implement a post-market monitoring plan that specifies the data to be collected, the monitoring frequency, the…
Related EU AI Act terms
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