EU publishes first harmonised standard supporting AI Act

The European Commission has published the reference to the first harmonised standard supporting the AI Act in the Official Journal of the European Union. Developed by CEN and CENELEC, the standard gives providers of high-risk AI systems a pathway to meet quality management requirements. Publication through Commission Implementing Decision (EU) 2026/2274 gives providers implementing it a presumption of conformity with the Article 17 requirements it covers.

EN 18286 translates those requirements into an operational quality management system built around the AI system lifecycle rather than the organisation. It is the only AI quality management standard with a presumption of conformity. It is designed to complement existing international or sectoral management standards, not replace them, and explicitly allows providers in regulated sectors to integrate their management systems.

Organisations without ISO/IEC 42001 that plan to place or put high-risk AI systems into service in the EU market can use the standard to expand an existing quality management system or build one meeting Article 17 requirements. Further harmonised standards are expected ahead of the application of requirements for high-risk AI systems.