First harmonised standard supporting the AI Act published in the Official Journal

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 regul...