The European Commission has published the reference to the first harmonised standard supporting the AI Act in the Official Journal of the European Union. The Commission says it gives providers of high-risk AI systems a way to meet the law's quality management system requirements.
The standard, EN 18286:2026, was developed by CEN and CENELEC. Its publication under Commission Implementing Decision (EU) 2026/2274 means providers that implement it benefit from a presumption of conformity with the Article 17 requirements covered by the standard.
EN 18286 turns those requirements into an operational quality management system, according to the Commission. It follows the lifecycle of an AI system rather than the structure of an organisation. The Commission says it is the only AI quality management system standard with a presumption of conformity.
Providers can add the standard to existing systems
Providers can add EN 18286 to an existing management system, including one based on ISO/IEC 42001, ISO 9001 or a sectoral standard such as ISO 13485. The Commission says providers in regulated sectors can integrate their management systems instead of running separate ones.
Organisations without ISO/IEC 42001 that plan to place high-risk AI systems on the EU market or put them into service there can use EN 18286 to expand an existing quality management system or build one that meets Article 17 requirements.
Further harmonised standards are expected to follow
The reference was published on 19 October 2026, ahead of the application of the AI Act's requirements for high-risk AI systems. The Commission says further harmonised standards are expected to follow.
