Duration: 1 Full Day | Timings: 9:00 AM - 4:30 PM | Format: Fast-paced, practical workshop
Course Introduction
Article 17 of the EU AI Act mandates a robust, documented Quality Management System (QMS) for all providers of high-risk AI systems. This one-day QMS QuickStart course delivers a clear, actionable understanding of exactly what must be included in your QMS - focusing on the written policies, procedures, and instructions required under the regulation.
You will leave with a solid blueprint for designing and documenting a compliant QMS that meets Article 17 obligations while remaining practical, proportionate, and aligned with your business operations.
Course Agenda
Morning Session: Strategy, Design & Development
-
Strategy for Regulatory Compliance
- Overall approach, substantial modifications, CE marking implications, and integration strategy.
-
Design, Design Control & Verification
- Techniques and procedures (SOPs) for high-risk AI system design and verification.
-
Development, Quality Control & Quality Assurance
- Systematic actions, techniques, and procedures (SOPs) for development and QA.
-
Examination, Test & Validation Procedures
- SOPs to be carried out before, during, and after development.
-
Technical Specifications & Standards
- Which standards to apply and how to demonstrate their use.
-
Data Management Systems
- Procedures aligned with Article 10 (data quality, governance, bias, provenance, and synthetic data).
Afternoon Session: Risk, Post-Market & Support Processes
-
Risk Management & Cybersecurity
- Full risk management system per Article 9 and cybersecurity requirements under Article 15.
-
Post-Market Monitoring System
- Setting up effective monitoring per Article 72.
-
Serious Incident Reporting
- Procedures for reporting under Article 73.
-
Communication with Authorities
- Systems and procedures for interacting with national competent authorities and other stakeholders.
-
Record-Keeping Systems
- Procedures (SOPs) for maintaining records, including 10-year retention obligations.
-
Resource Management & Suppliers
- Controls over resources, including supply chain oversight.
-
Accountability Framework
- Clear definition of roles, responsibilities, authorities, and governance.
Emphasis will be placed on creating a practical understanding of EU AI Act Article 17 requirements.
Fast-track your Article 17 QMS implementation and gain clarity on exactly what regulators expect.
