Clause 4 of prEN 18286 ('Context of the organisation' and 'Quality Management System') is the foundation of the entire standard. It requires organisations to understand their context, determine the scope of the QMS, establish the system requirements, and ensure clear relationships between all processes, procedures and activities.
This clause sits at the heart of Article 17 compliance: it defines what the QMS covers, how its elements interrelate, and provides the traceability matrix that proves every requirement of prEN 18286 (and the EU AI Act) is addressed. Without a robust system-level view, even perfect processes will fail notified-body scrutiny.
This 1-day practical workshop turns Clause 4 into a living system. You will leave with a documented QMS scope, a process relationship map, a complete traceability matrix and an implementation plan - everything needed to demonstrate a coherent, auditable QMS for high-risk AI systems (autonomous agents, RAG pipelines, continuously learning models, multi-agent architectures, etc.).
By the end of the day, participants will be able to:
This intensive 1-day workshop transforms Clause 4 of prEN 18286 from a high-level requirement into a practical, coherent system framework. You leave with a documented QMS scope, a clear map of process relationships, and a complete traceability matrix - giving your Quality Management System the structural integrity required to pass notified-body audits and maintain long-term compliance under the EU AI Act.