EU Publishes First Harmonised Technical Standard Under AI Act

The European Commission published the first harmonised standard under the EU AI Act, EN 18286:2026 on AI quality management systems, on October 14, according to an analysis by Orrick. The standard gives providers of high risk AI systems a presumption of conformity with requirements covering technical documentation and quality management under Articles 11(1) and 17(1) of the EU AI Act.

EN 18286 covers regulatory strategy, leadership, accountability, staff competence, data management, system testing, supply chain controls, post market monitoring and serious incident reporting. It follows the management structure used by ISO/IEC 42001 and ISO 9001, allowing providers to add its processes to existing management systems. Compliance is voluntary, and using other standards alone does not provide the same presumption of conformity.

The standard does not change conformity assessment routes for most high risk systems. Providers can purchase the full technical specifications from national standards bodies, while the Official Journal of the European Union publishes only the reference. Additional harmonised standards are being prepared for areas including risk management, data governance, recordkeeping, transparency, human oversight, accuracy, robustness and cybersecurity.