Announcing prEN 18286 – the Quality Management System (QMS) for High-Risk AI
The Quality Management System (QMS) standard written for EU AI Act regulatory purposes, is out for enquiry. This maps directly to Article 17 obligations on providers of high-risk AI.
It defines how providers establish, maintain, and evidence a QMS across the AI system lifecycle from risk management and data governance to verification/validation, supply-chain control, post-market monitoring, and serious-incident reporting. It is not a checklist; it is a system for leadership, accountability, and continuous improvement.
After it has been published in the Official Journal, conformity with the harmonised version of prEN 18286 gives a presumption of conformity to the specific AI Act requirements listed in the standard. The applicable conformity route remains the one defined by the AI Act for your system e.g., internal control vs. notified body involvement.
We also believe its design carries transferability beyond Europe. Through the EU AI Act’s golden thread of OECD and EU High-Level Expert Group principles, prEN 18286 may yet influence quality assurance for AI in other jurisdictions – reinforcing the convergence of global AI governance norms.
At Anekanta®, we’ve been preparing for this moment for four years. While ISO/IEC 42001 provides the organisational ISO ‘Plan, Do, Check, Act’ backbone for an AI Management Systems, prEN 18286 goes further – translating the specific legal and technical obligations of the EU AI Act into operational practice.
It is a framework for regulatory compliance, leadership and competitive advantage – for embedding quality and accountability at every stage of AI system design, development, and deployment.
In Anekanta®’s forthcoming articles and newsletters we will unpack what prEN 18286 truly means for boards, deployers, and providers, cutting through the noise to reveal how to leverage business and regulatory value.
Bookmark Anekanta®‘s Resource Centre for the EU AI Act.
Anekanta® provides a full range of strategy, risk, literacy ad governance services to businesses developing, integrating and using AI systems. Our EU AI Act Compliance Services focus on high-risk AI requirements, AI Literacy and preparation for the new QMS.
Learn more about Anekanta®‘s EU AI Act Compliance Services
Anekanta®AI and Anekanta®Consulting
AI Strategy | Risk | Literacy | Governance
Contact us | Explore our services | Subscribe to our newsletter | Follow us on LinkedIn
Original content created by Anekanta® is © Copyright 2016-2025. All rights reserved.
Nothing published by Anekanta® constitutes legal advice nor should it be construed as such. Content is produced for illustrative purposes to promote commercial services.