Overview
This comprehensive 40+ hour self-paced program delivers a structured methodology for designing, implementing, and sustaining a product-centric Quality Management System fully aligned with EN 18286:2025 - the harmonised European standard for regulatory compliance under the EU AI Act.
Participants gain practical expertise in building a verifiable QMS that generates evidence of conformity with the EU AI Act's essential requirements, including risk management, data governance, transparency, human oversight, accuracy, robustness, and cybersecurity. Ideal for organisations seeking presumption of conformity and streamlined EU market access.
What You Will Learn
By the end of this course, participants will be able to:
- Design and implement a complete product-centric QMS aligned with EN 18286
- Generate verifiable evidence of conformity with EU AI Act essential requirements
- Master risk management, data governance, human oversight, and post-market monitoring
- Prepare for notified-body assessments and successful EU market access
- Build an audit-ready system that supports continuous improvement and regulatory compliance
Course Structure
The course covers: Foundation & Introduction to EN 18286 - Context, Leadership & Planning (Clauses 4-6) - Support & Resources (Clause 7) - Operational Control (Clause 8) - Performance Evaluation & Improvement (Clauses 9-10) - Final Examination & Conformity Readiness.