EU AI Act Quality Management System Training

Overview of EU AI Act
Requirements for
Quality Management Systems

Clause-by-clause review of Article 17 - the mandatory QMS for high-risk AI systems

Dates
1 - 2 July 2026
Day One
09:00 - 16:30 GMT+1
Day Two
09:00 - 16:30 GMT+1
Format
Live Online
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AI Assurance Institute

Presented by

AI Assurance Institute

15+ years Specialized AI governance training
33 events hosted Across Europe, UK & US
Article 17 clause-by-clause
prEN 18286 overview
Interconnections with full AI Act

Why This Course Exists
The 2026 Regulatory Reality

Under the EU Artificial Intelligence Act (Regulation (EU) 2024/1689), providers of high-risk AI systems face one of the most demanding obligations in modern AI regulation: the mandatory establishment, documentation, implementation, and continuous maintenance of a Quality Management System (QMS) as required by Article 17.


This comprehensive review course delivers a thorough, clause-by-clause examination of these extensive requirements, providing participants with a deep, contextual understanding of how the QMS must operate as the central governance mechanism for trustworthy, compliant high-risk AI throughout its entire lifecycle.


Unlike longer implementation-focused programs, this course is designed to provide an overview of the requirements. It systematically unpacks all 13 mandatory elements of Article 17, explores their interconnections with other key provisions (Articles 9, 10, 11, 15, 43, 72, 73, and Annex IV), and analyses the deliberate shift to a product-centric, lifecycle-oriented QMS architecture.


Special emphasis on the draft harmonised standard prEN 18286 (revisions currently underway; full publication expected late 2026).

What You Will Learn & Achieve

  • Confidently articulate the full scope and intent of Article 17's extensive QMS requirements and their interconnections with the broader AI Act framework
  • Critically analyse the practical implications, challenges, and edge cases (e.g., continuously learning systems, GPAI-to-high-risk transitions)
  • Evaluate your organisation's current practices against the mandatory elements and prEN 18286
  • Understand the current regulatory timeline and the difference between immediate legal obligations (mandatory from 2 August 2026) and future presumption of conformity
  • Develop informed compliance strategies that balance regulatory rigour with innovation speed and competitive advantage

Course Focus

13 mandatory elements of Article 17 + interconnections with Articles 9, 10, 72 - 73 & Annex IV
Product-centric, lifecycle-oriented QMS architecture vs. traditional ISO 9001 / ISO/IEC 42001

Detailed 2-Day Agenda

1
Day 1 - 1 July 2026

Core Requirements & Lifecycle Processes

  • 09:00 Strategy for regulatory compliance and substantial modifications - Triggers, documentation, and impact on CE marking
  • 10:30 Design, development, verification, validation, and quality assurance = AI-specific techniques for robustness, accuracy, cybersecurity, and continuously learning models
  • 13:00 Data management and governance - Full alignment with Article 10 (bias detection, provenance, synthetic data)
  • 15:00 Risk management system - Iterative application of Article 9 across health, safety, and fundamental rights risks
9:00am - 4:30pm GMT+1 - Includes breaks and Q&A
2
Day 2 - 2 July 2026

Operation, Monitoring & Integration

  • 09:00 Post-market monitoring, serious incident reporting, and communication - Integration with Articles 72 - 73 and supply-chain oversight
  • 11:00 Resource management, accountability frameworks, and record-keeping - 10-year retention obligations
  • 13:30 Proportionality, integration, and special regimes - SME-friendly simplifications, overlap with MDR/IVDR, and pathways for existing ISO systems
  • 15:00 Strategic compliance planning & prEN 18286 roadmap
9:00am - 4:30pm GMT+1 - Analytical deep-dive with real-world case studies

Who Should Attend

Ideal for anyone responsible for regulatory compliance of high-risk AI systems in 2026 and beyond.

AI Developers & Engineers
Risk & Compliance Officers
Data Protection Officers (DPOs)
Quality & Assurance Leads
No prerequisites - perfect for both technical and governance professionals

Key Benefits & Unique Value

Clause-by-Clause Review

Complete review of all 13 mandatory elements of Article 17

Full AI Act Interconnections

How QMS links to risk management (Art 9), data governance (Art 10), post-market monitoring (Art 72) and more

Strategic Advantage

Balance compliance with innovation, including SME simplifications and prEN 18286 roadmap

Understand the Central Pillar of EU AI Act Compliance

Gain the regulatory understanding you need to build quality management systems for high-risk AI systems.

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+ Live interactive sessions
+ Comprehensive analysis
+ Q&A with experts