Duration: 2 Days | Timings: 9:00 AM - 4:30 PM each day | Format: Interactive
Course Introduction
The EU AI Act introduces mandatory Quality Management System (QMS) requirements under Article 17 for high-risk AI systems. This course provides a comprehensive, actionable overview of how to design, implement, and maintain a compliant QMS that aligns with the Act's obligations while supporting innovation and business efficiency.
Day 1 Agenda: Foundations & Core QMS Elements
Key Focus: Strategy, Design, Risk, Data & Governance
- Introduction, Mandate, Scope, Regulatory Requirements, Approach & Essential Requirements
- Demonstrating Compliance, Documented QMS, Operational Documentation
- Clause 5: Governance & Management (roles, responsibilities, accountability framework, quality policy)
- Clause 6: Planning (risk determination, quality objectives, planning actions)
- Clause 7: Supporting Resources (AI literacy, competence, infrastructure, awareness & communication)
Day 2 Agenda: Implementation, Operations & Continuous Improvement
Key Focus: Execution, Monitoring & Post-Market Obligations
- Clause 8: Product Realization
- Actions to address risks (RMS)
- AI system lifecycle SOPs & objective evidence
- Inception, Design & Development
- Verification & Validation
- Data management
- Environmental sustainability, Technical Documentation, Instructions for Use
- Clause 9: Operation & Control
- Operation control, traceability, supply chain control, deployer feedback
- Problem management & support channels
- Post-market monitoring, serious incident reporting (Articles 72-73)
- Clause 10: Performance Evaluation
- Management review procedures & outputs
- QMS effectiveness review
- Improvement procedures and change management
Prepare your organisation for AI Act compliance with confidence and clarity.