Harmonised standard (European Union)
EN 18286:2026 (AI quality management system standard)
EN 18286:2026, Artificial intelligence - Quality management system for EU AI Act regulatory purposes, is a European standard drafted by CEN and Cenelec at the Commission's request. Its reference was published in the Official Journal on 14 October 2026, making it the first harmonised standard for high-risk AI systems under the EU AI Act.
Last reviewed 28 Oct 2026
Facts at a glance
| Full title | Artificial intelligence - Quality management system for EU AI Act regulatory purposes source |
|---|---|
| Drafted by | CEN and Cenelec |
| Standardisation request | Commission Implementing Decision C(2025) 3871 of 23 June 2025, Annex I point 9 source |
| Referenced by | Commission Implementing Decision (EU) 2026/2274 of 12 October 2026 source |
| Published in the Official Journal | 14 October 2026 (L series) source |
| Legal effect | Presumption of conformity under Article 40 of Regulation (EU) 2024/1689 for the requirements it covers source |
Questions people ask
- What does EN 18286 cover?
- Quality management systems for providers of AI systems, including post-market monitoring processes, as requested in point 9 of Annex I to the Commission's standardisation request C(2025) 3871.
- Is EN 18286 mandatory?
- No. Harmonised standards are voluntary. A provider that follows it gets a presumption of conformity with the AI Act requirements it covers, under Article 40 of the AI Act.