EN 18286 and ISO/IEC 42001. EN 18286:2026, Artificial intelligence: Quality management system for EU AI Act regulatory purposes, is the first harmonized standard cited in the Official Journal under the AI Act, through Commission Implementing Decision (EU) 2026/2274. A provider of a high-risk AI system that applies it gets a presumption of conformity with the Article 17 quality management system requirements the standard covers. It does not cover the rest of the Act, such as risk classification, technical documentation, human oversight or conformity assessment, and applying it is voluntary. The European Commission explains that EN 18286 is designed to sit on top of existing management systems such as ISO/IEC 42001, ISO 9001 or a sector quality system, so an organization running an ISO/IEC 42001 AI management system can extend it with the EN 18286 requirements instead of building a second system. ISO/IEC 42001 certification on its own does not establish compliance with the EU AI Act or give the Article 17 presumption. Checked November 7, 2026.
About the percentages in this companion. ISO/IEC 42001 itself has no weighted domains. The percentages in the sidebar and checklist are the exam weights PECB publishes for its ISO/IEC 42001 Lead Implementer certification (Candidate Handbook: 17, 5, 20, 18, 10 and 10 of 80 questions, or 21.25%, 6.25%, 25%, 22.5%, 12.5% and 12.5%). They tell you how that exam is weighted, not how important each clause is to an AI management system.