October 20, 2026 · AI Act
EU publishes first harmonised standard supporting the AI Act
Standard EN 18286:2026 on quality management systems under Article 17 of the AI Act has been published in the Official Journal of the EU and gives providers of high-risk AI systems a route to a presumption of conformity.
The European Commission has published in the Official Journal of the European Union the reference to the first harmonised standard supporting the implementation of the AI Act. The standard, EN 18286:2026 «Artificial intelligence – Quality management system for EU AI Act regulatory purposes», was developed by CEN and CENELEC.
The standard explains how providers of high-risk AI systems can meet the quality management system requirements under Article 17 of the AI Act. Through its publication in Commission Implementing Decision (EU) 2026/2274, providers that implement the standard benefit from a presumption of conformity with the Article 17 requirements it covers.
The standard focuses on the AI system lifecycle rather than the organisation as a whole. It can be built on existing standards such as ISO/IEC 42001, ISO 9001 or sectoral systems such as ISO 13485, rather than replacing them. Companies in regulated sectors can therefore extend an existing system instead of running a separate one.
Organisations without ISO/IEC 42001 that intend to place high-risk AI systems on the EU market or put them into service in the EU can use the standard to extend an existing quality management system or to build a first one.
The requirements for high-risk AI systems apply from December 2027 or August 2028. Further harmonised standards are expected to follow.
