This course offers a detailed examination of EN 18286, the European standard for Artificial Intelligence Quality Management Systems, crafted for regulatory purposes.
This course delivers a structured and in-depth methodology for managing the quality of artificial intelligence systems, fully aligned with EN 18286:2025—the European standard for quality management systems dedicated to regulatory compliance under the EU AI Act.
Participants will gain practical expertise in designing, implementing, and sustaining a product-centric Quality Management System that generates verifiable evidence of conformity with the essential requirements of Regulation (EU) 2024/1689, including risk management, data governance, transparency, human oversight, accuracy, robustness, and cybersecurity, thereby facilitating presumption of conformity and streamlined market access within the European Union
Course Outline
- Introduction (1 hour) – About the EN 18286 QMS
- Clause 4 (7.3 hours) – Context & Leadership
The revolutionary product-centric architecture vs ISO 9001/42001 · Scope definition around individual high-risk AI systems · Interested parties & fundamental-rights stakeholders
- Clause 5 (2.2 hours) – Top-management commitment
AI QMS quality policy · accountability structures · roles & responsibilities
- Clause 6 (2.2 hours) – Planning the QMS
AI-specific risks & opportunities (safety + fundamental rights) · Measurable AI quality objectives · Planning of changes & substantial-modification assessment · Risk treatment plans linked to Articles 9–15
- Clause 7 (5 hours) - Support & Resources
Competence requirements (bias detection, explainability, fundamental-rights expertise) · Documented information & 10-year retention · Technical documentation structure (Annex IV)
- Clause 8 (13 hours) – Operational Control
Design & development controls · Data governance (Article 10) · External providers · Traceability & model cards · Model-drift monitoring & alert thresholds · Human oversight · Release procedures · Post-market monitoring & serious-incident reporting
- Clause 9 (15 hours) – Performance Evaluation
Monitoring accuracy, robustness, fairness & fundamental-rights impact · Deployer & societal feedback loops · Internal audit programme · Management review in continuously learning systems
- Clause 10 (5 hours) – Improvement & Conformity Readiness
Nonconformity & corrective action · Continual improvement in dynamic AI · Integration with ISO 9001 / 13485 / 42001 · Notified-body preparation (Module A vs H)
Who Should Attend:
This course is designed for:
- AI Product Owners & Technical Leads
- Quality, Regulatory & Compliance Managers
- Governance, Risk & Compliance (GRC) professionals
- MLOps, Data Science and AI Ethics teams
- Legal counsel specialising in AI regulation
- Consultants and auditors preparing for EU AI Act assessments
Course details:
This comprehensive fifty-hour virtual course is accessible twenty-four hours a day, offering flexibility for participants to engage at their convenience. The program concludes with a concise examination consisting of fifty questions, designed to verify the effective transfer of knowledge to the attendee. Upon confirmation of course registration, participants will gain immediate access to the course materials and may commence their studies without delay.
Cancellation/Refund Policy
A full refund is available should the participant find the course unsatisfactory. In such instances, the purchaser may elect to receive a complete reimbursement of the course fee or apply the fee as credit toward a subsequent course. Any refund will be processed using the original payment method. The organizer assumes no liability for losses or expenses incurred by the participant or purchaser, regardless of the circumstances.
Payment
Payment is required on registration using an electronic payment method.
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