Article 17 of 11315%
Article 17: Quality management system
EU Official:
Title III: High-Risk AI Systems
Article 17 requires providers of high-risk AI to implement a quality management system ensuring compliance with the AI Act. This must be documented systematically in written policies, procedures and instructions.
Official text
||
Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.
Download AI Act (PDF) →Official guidance on this article
2- EN ISO/IEC 42001:2026 Information technology - Artificial intelligence - Management systemProvides the governance and management structure on which a quality management system within the meaning of Article 17 can be built, but does not itself cover the statutory requirement because the standard is not harmonisedPublishedStandardISO/IEC JTC 1/SC 42, European adoption through CEN-CENELEC, Dutch adoption by NEN1 Mar 2026
- EN 18286:2026 Artificial intelligence - Quality management system for EU AI Act regulatory purposesTranslates the requirement from Article 17 that providers of high-risk AI systems have a quality management system into concrete measurable requirements for policy, lifecycle management, documentation and monitoringPublishedStandardCEN-CENELEC (JTC 21), Dutch adoption by NEN31 Jul 2026
Related enforcement
No enforcement actions for this article yet. Follow developments via the Enforcement Tracker.
Related blog posts
Related articles
Frequently asked questions
What is the quality management system under Article 17 AI Act?+
Article 17 requires providers of high-risk AI to implement a quality management system ensuring compliance with the AI Act. This must be documented systematically in written policies, procedures and instructions.
What must a quality management system for AI contain?+
The system must include compliance strategies, design and development techniques, quality control, risk management procedures, and a post-market monitoring system, among other elements.
What documentation does Article 17 of the AI Act require?+
Article 17 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.