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Processes, Procedures & Activities under EN 18286

Aligning Your AI Lifecycle with Quality Objectives and Traceability

Overview

This intensive 1-day hands-on workshop focuses on Clause 8 (Operation) of EN 18286 - the engine room of your QMS. It requires organisations to define, document, implement, and control all processes across the full AI lifecycle, from design and data governance through verification, deployment, monitoring, and decommissioning.

You will leave with complete process maps, documented procedures, a Quality Policy/Objectives alignment matrix, and a robust traceability matrix ready for notified-body review.

What You Will Learn

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

  • Map the full AI lifecycle processes required by EN 18286 Clause 8 and link them to regulatory obligations
  • Develop clear, consistent, and operationally effective documented procedures
  • Align every process with the organisation's Quality Policy and measurable Quality Objectives
  • Build and maintain a comprehensive traceability matrix proving end-to-end coverage of EN 18286 and Article 17
  • Integrate process controls with risk management, data governance, and post-market monitoring

Course Structure

The workshop covers: Clause 8 Deep-Dive - AI Lifecycle Processes & Procedures - Process Mapping & Procedure Writing Workshop - Aligning Processes with Quality Policy & Objectives - Traceability Matrix Creation & Audit Readiness - Personalised 30-Day Rollout Plan & Evidence Package Review.

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