Harmonised Standard EN 18286:2026 on AI QMS

Commission Implementing Decision (EU) 2026/2274 of 12 October 2026 on the harmonised standards for high-risk AI systems drafted in support of Regulation (EU) 2024/1689 of the European Parliament and of the Council

The Implementing Decision publishes in the Official Journal the reference of the harmonised standard EN 18286:2026 "Artificial intelligence – Quality management system for EU AI Act regulatory purposes", which is listed in its Annex. The Decision is adopted under Article 10(6) of Regulation (EU) No 1025/2012 on European standardisation. It recalls that, under Article 40 AIA, high-risk AI systems or general-purpose AI models that conform to harmonised standards, or parts thereof, whose references are published in the Official Journal are presumed to conform with the AIA requirements covered by those standards. The standard was drafted by CEN and Cenelec in response to the Commission's standardisation request in Implementing Decision C(2025) 3871 of 23 June 2025. It corresponds to point 9 of Annex I to that request, which concerns quality management systems for providers of AI systems, including post-market monitoring processes. The Commission, together with CEN and Cenelec, assessed the standard's compliance with the request before publication of its reference. The Decision entered into force on the day of its publication in the Official Journal, 14 October 2026, which is the date from which the presumption of conformity applies.