One-day course on Clause 4: context, scope and the QMS as a system
Clause 4 of EN 18286 is the foundation of the QMS. It requires the organisation to understand its context, determine the scope of the quality management system, set system requirements, and show how the processes relate to each other.
When the product is an AI system, those decisions are easy to get wrong. Scope that is too wide cannot be operated. Scope that is too narrow leaves a high-risk use outside the QMS. This one-day course covers how to draw the boundary and how to show process relationships across the life cycle.
Duration: one day. Format: taught course. Dates are on the training calendar.
Interested parties for an AI QMS: the governing body, users, people affected by the system, regulators, notified bodies, deployers and suppliers. Legal duties that sit next to the Act, including GDPR where personal data is processed. AI uses that belong inside the QMS and uses that sit beside it.
Determining and documenting QMS scope. Which high-risk systems are in. Which sites, teams and suppliers are in. Where a general-purpose model, a fine-tune or a third-party component sits relative to that boundary. How a change of intended purpose forces a review of scope.
Requirements that stay proportionate, product-centric and life-cycle oriented. Mapping how processes interact across design, data, verification, release, monitoring and withdrawal. A process with no upstream trigger, or no downstream record, is a gap in Clause 4, not only in Clause 8.
How EN 18286 clauses connect to Article 17 items and then to the records those processes produce. A clause with no process, a process with no record, or a record that cannot be tied to a version of the system, is visible once that chain is drawn.
Clause 4 does not invent those processes; it requires them to appear as part of one system. The last block is how risk management, data governance and post-market monitoring are named in the scope and in the process map so they are not three parallel files.
Quality managers and architects of the QMS who will write the scope and the process map. Product and compliance leads who must say which AI uses sit inside that scope. Fundamentals or the two-day Overview are the usual prior days.
