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System Requirements
under EN 18286

Establishing the QMS, Process Relationships & Traceability Matrix

Overview

This intensive 1-day hands-on workshop focuses on Clause 4 (Context of the Organisation & Quality Management System) of EN 18286 - the foundation of your entire QMS. It requires organisations to understand their context, determine QMS scope, establish system requirements, and ensure clear relationships between all processes.

You will leave with a documented QMS scope, a process relationship map, a complete traceability matrix, and an implementation plan ready for notified-body review.

What You Will Learn

By the end of this workshop, participants will be able to:

  • Determine and document the scope of the QMS under EN 18286 Clause 4, including boundaries for high-risk AI systems
  • Map the relationships and interactions between all QMS processes across the full lifecycle
  • Build and populate a comprehensive traceability matrix linking EN 18286 clauses to EU AI Act Article 17 requirements
  • Ensure system requirements are proportionate, product-centric, and lifecycle-oriented
  • Integrate system-level controls with risk management, data governance, and post-market monitoring

Course Structure

The workshop covers: Clause 4 Deep-Dive - Context, Scope & System Requirements - QMS Boundaries & Process Relationship Mapping Workshop - Traceability Matrix Building (EN 18286 ? Article 17 ? Evidence) - Integration with Other Clauses & Regulatory Obligations - Personalised 30-Day Rollout Plan & Evidence Package Review.

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