AI Assurance Institute Logo AI Assurance Institute

Regulatory Compliance Strategy under EN 18286

Building the Mandatory Process for High-Risk AI Systems

Overview

This intensive 1-day hands-on workshop focuses on creating the single most important document in your QMS: the Regulatory Compliance Strategy required by EN 18286 (Clauses 5 & 6). This living document defines how your organisation ensures ongoing conformity with the EU AI Act, manages substantial modification triggers, and maintains CE marking across all high-risk AI systems.

You will leave with a complete, ready-to-deploy Regulatory Compliance Strategy document, all supporting templates, and a personalised 30-day implementation plan.

What You Will Learn

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

  • Map the Regulatory Compliance Strategy requirement in EN 18286 to Article 17 obligations
  • Define clear criteria for substantial modification triggers across model updates, data changes, and system modifications
  • Design conformity assessment procedures and CE-marking maintenance processes tailored to different AI system types
  • Build a documented strategy that integrates risk management, data governance, and post-market monitoring
  • Create auditable evidence matrices, change-control logs, and a 30-day rollout plan

Course Structure

The workshop covers: EN 18286 Clauses 5 & 6 Deep-Dive & Article 17 Mapping - Substantial Modification Triggers & Strategy Framework Workshop - Conformity Assessment Routes & CE Marking Procedures - Evidence Matrix & Audit-Ready Documentation - Personalised 30-Day Rollout Plan & Document Review.

Register for Upcoming Training

Training Calendar