Source-traceable links from AI Act changes and obligations to actors, actions, evidence, controls and public tools.
EU Artificial Intelligence Act 2024/1689
Responsible AI Platform release validation
The documented quality system through which a high-risk AI provider structurally assures compliance.
The provider places high-risk AI systems on the market or puts them into service.
Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.
Article 17 requires a documented quality management system covering a compliance strategy, design and development procedures, data management, risk management, post-market monitoring, incident reporting and an accountability structure.
For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.
The QMS is the umbrella over all other provider duties: those with the separate files but no system connecting them fail exactly this article in an audit.
Build the QMS not as a separate document but as an index on top of the existing files (risk, data, documentation, monitoring) with owners per procedure.