The European Commission published the reference to the first harmonised standard supporting the AI Act in the Official Journal of the European Union on 19 October, through Commission Implementing Decision (EU) 2026/2274. Providers that implement EN 18286:2026 gain a presumption of conformity with the Article 17 quality management system requirements covered by the standard.
CEN and CENELEC developed the standard, titled Artificial intelligence – Quality management system for EU AI Act regulatory purposes. The Commission says it is the only AI quality management system standard with that presumption. Its requirements follow the AI system lifecycle rather than the organisation.
Providers can use EN 18286 alongside ISO/IEC 42001, ISO 9001 or a sectoral quality management system such as ISO 13485. The Commission says providers in regulated sectors can integrate it into an existing system rather than operate a separate one. Organisations without ISO/IEC 42001 that intend to market high-risk AI systems in the EU or put them into service there can use EN 18286 to expand an existing quality management system or build their first to meet Article 17 requirements. Requirements for high-risk AI systems under the AI Act apply from December 2027 and August 2028.
