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EU AI Act (EU) 2024/1689 - Article 17: Quality Management System Requirements for Providers of High-Risk AI Systems

Article 17 mandates that every provider of a high-risk AI system document and implement a Quality Management System (QMS) proportionate to the…

What EU AI Act (EU) 2024/1689 - Article 17: Quality Management System Requirements for Providers of High-Risk AI Systems requires

Article 17 mandates that every provider of a high-risk AI system document and implement a Quality Management System (QMS) proportionate to the organisation's size and the risk level of the AI system. The QMS must address at minimum: (a) regulatory compliance strategy; (b) design, development, and quality control techniques; (c) systematic review of design before and after market placement; (d) examination, testing, and validation of the AI system and data; (e) technical specifications including standards applied; (f) data management including training, validation, and testing datasets; (g) risk management per Article 9; (h) post-market monitoring per Article 72; (i) accountability, responsibility, and authority procedures; (j) procedures for reporting serious incidents per Article 73; (k) communication with authorities; (l) record-keeping; and (m) resource management. SMEs may apply a simplified approach proportionate to their size.

Pillar: AI Governance & Law · Authority: European Parliament and the Council of the European Union · Version: 2.0 · Last updated:

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689

SHA-256 integrity: f8edaa67ee9973e5f418764892e53d9d2bd20ad323e5677653ea1461b6b795d2

Primary Citations — 8 traced to source

  • {"title":"EU AI Act (EU) 2024/1689 - Article 17: Quality Management System","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689","section":"Article 17"}
  • {"title":"EU AI Act (EU) 2024/1689 - Article 9: Risk Management System","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689","section":"Article 9"}

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