Article 17
Quality management system
High riskApplicable from August 2, 2026
Applies to: Provider
Providers of high-risk AI systems must put in place a documented quality management system covering strategy, procedures, and responsibilities for regulatory compliance.
Key points
- Written policies, procedures, and instructions covering the full lifecycle
- Design control, development, verification, and testing procedures
- Data management and risk management procedures
- Post-market monitoring and serious-incident reporting arrangements
- Accountability framework covering management and staff responsibilities
Related terms
This page is a plain-language summary for orientation only. It is not legal advice — the binding text is Regulation (EU) 2024/1689.