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What is Quality management system?

In the EU AI Act, a quality management system is a documented set of policies, procedures and instructions that a provider of high-risk AI systems must keep to ensure compliance across the system's lifecycle, covering design, development, testing, data management, risk management, monitoring and incident reporting.

Article 17 lists the aspects to include and allows the effort to be proportionate to the size of the organisation. It is a provider obligation and is separate from, though can be combined with, an ISO/IEC 42001 AI management system or other quality systems.

Source: Regulation (EU) 2024/1689 (the EU AI Act), EUR-Lex. Last reviewed 3 October 2026. General information, not legal advice.

See also

  • Provider
  • AI management system (AIMS)
  • Technical documentation
  • Post-market monitoring

Go deeper

  • EU AI Act guide
  • ISO/IEC 42001 guide

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