Article 17High-risk
Quality management system
Provider
Deadline: August 2, 2026
Article 17 requires providers of high-risk AI systems to establish a quality management system ensuring compliance with the regulation. This system must cover all phases of the AI system lifecycle and be systematically documented.
Key points
1Documented regulatory compliance strategy
2Design, design control and verification procedures
3Examination, testing and validation procedures before and after market placement
4Technical specifications including applied standards
5Systems and procedures for managing training, validation and test data
6Procedures for reporting serious incidents and malfunctions
Related definitions
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