First harmonised standard under the EU AI Act, EN 18286, cited in the EU Official Journal

According to Nemko Digital on 16 October 2026, Commission Implementing Decision (EU) 2026/2274 was published in the EU Official Journal on 14 October 2026 and entered into force the same day. It lists EN 18286:2026, "Artificial intelligence – Quality management system for EU AI Act regulatory purposes", as the first harmonised standard cited under the Act.

• The European standards bodies CEN and CENELEC developed the standard under a Commission standardisation request.
• EN 18286 covers the quality management system providers must run, including post-market monitoring; it does not assess the technical performance of an individual model.
• According to Orrick, the standard relates to Articles 11(1) (technical documentation) and 17(1) (quality management system); the presumption of conformity covers only the requirements the standard addresses.
• Applying the standard is voluntary; providers may show compliance by other means.

Why it matters

Orrick's analysis of 27 October 2026 notes that following ISO/IEC 42001 or ISO 9001 alone does not give this presumption. The Official Journal carries only the reference; the full text is sold by national standards bodies such as AFNOR, DIN, UNI and BSI. According to Nemko, the Commission's standardisation programme also covers areas such as risk management, data governance, human oversight and cybersecurity; Orrick says those standards are at different stages of development. For Turkish software companies that offer, or plan to offer, high-risk AI systems in the EU market, comparing current quality processes with EN 18286 can be a practical first step.