First EU AI Act harmonised standard

The European Commission has published the reference to the first harmonised standard supporting the implementation of the AI Act in the Official Journal of the European Union.

The standard, EN 18286:2026 - Artificial intelligence - Quality management system for EU AI Act regulatory purposes, developed by CEN and CENELEC, provides a clear legal pathway for providers of high-risk AI systems to comply with the quality management system requirements under article 17 of the AI Act.

Its publication through Commission Implementing Decision (EU) 2026/2274 means that providers implementing this standard will benefit from a presumption of conformity with the Article 17 requirements covered by the standard.

EN 18286 translates these requirements into an operational quality management system (QMS). It is the only AI QMS standard with a presumption of conformity. It is mapped to Article 17 of the AI Act, built around the AI system lifecycle – rather than the organisation – and designed to be layered on top of the existing international standards – such as ISO/IEC 42001, ISO 9001 or a sectoral QMS (e.g. ISO 13485) – rather than replace them.

EN 18286 explicitly allows providers in regulated sectors to integrate management systems, rather than run separate ones. Organisations without ISO/IEC 42001 that plan to place or put into service high-risk AI systems in the EU market can use EN 18286 to expand an existing QMS or build one that fulfills the requirements of article 17 requirements.

The publication of this standard marks an important milestone in implementing the AI Act, ahead of the application of requirements for high-risk AI systems, with further harmonised standards expected to follow.

Find further information about the Standardisation of the AI Act.