EN 18286 QMS for AI Act Compliance

Overview

This is the extended programme. It works through EN 18286 clause by clause as the method for designing, implementing and sustaining a product-centric quality management system aligned to Article 17 of the EU AI Act.

The course covers how a QMS generates evidence against the Act's essential requirements: risk management, data governance, transparency, human oversight, accuracy, robustness and cybersecurity. It is written for organisations that will take a high-risk system through assessment and need the clauses as a working sequence, not as a one-day map.

What the programme covers

• designing the QMS around the product and its intended purpose, rather than around a generic quality manual;
• implementing each EN 18286 clause so it leaves records an assessor can follow;
• risk management, data governance, human oversight and post-market monitoring as operating processes;
• how those processes produce the evidence later used in technical documentation and conformity assessment;
• keeping the QMS current when the system, the data or the intended purpose changes.

How it is run

Self-paced structured programme, more than 40 hours of study. It sits above the one-day clause courses: those days go deep on one clause; this programme sequences the whole standard.

Who it is for

Quality leads, conformity coordinators and implementation teams who will own the QMS across the life of a high-risk product.