On 19 October 2026, the European Commission published the reference to EN 18286:2026 in the Official Journal of the European Union. The standard, developed by CEN and CENELEC, describes a quality management system for regulatory purposes under the AI Act.
Providers that apply EN 18286 receive a presumption of conformity with the requirements from Article 17 covered by the standard. The standard translates these requirements into an operational quality management system and, according to the Commission, is the only AI quality management standard with such a presumption of conformity.
EN 18286 is structured around the life cycle of the AI system rather than the organisation. The standard can be added to existing systems, such as ISO/IEC 42001, ISO 9001 or a sector-specific quality management system such as ISO 13485. According to the Commission, providers in regulated sectors can integrate the requirements instead of setting up a separate management system.
Organisations without ISO/IEC 42001 can use EN 18286 to extend an existing quality management system or build an initial system for the requirements of Article 17. The publication precedes the application of the requirements for high-risk AI systems in December 2027 and August 2028. Further harmonised standards are expected.
