One-day course on Clauses 5 and 7: leadership, competence and awareness
Clauses 5 and 7 of EN 18286 are the human side of the QMS. Clause 5 requires leadership and commitment: a documented accountability framework, named roles, and a quality policy that operations can implement. Clause 7 requires support: competence, awareness and the training that makes those roles real.
This one-day course covers how those clauses are applied to an AI life cycle. Intended purpose, risk, data, release, monitoring and change each need an owner who can be found, and competence that matches the work, not only a general quality qualification.
Duration: one day. Format: taught course. Dates are on the training calendar.
What Clause 5 expects leadership to show: the quality policy, the resources for the QMS, and the review of whether the QMS is working. Commitment that exists only as a signature on a manual is not enough when the product can change behaviour after release.
Who is accountable for intended purpose, risk, data, design, verification, release, monitoring, suppliers and change. How responsibility, accountability, consultation and information are assigned across those functions so two teams do not each assume the other owns a high-risk use.
How role descriptions are written for AI work: what the person must be able to decide, what they must see, and when they must escalate. The day works through governing-body, management and operational roles so Article 17 later has names, not only functions.
What competence looks like for this product: bias, explainability, drift, human oversight, and the limits of a model that adapts after release. A general QMS qualification does not by itself meet Clause 7 for those tasks.
How a training and awareness programme is scoped to the roles above. Criteria for whether the programme worked: can the named person perform the activity the procedure assigns to them.
An assessor looking at the human framework asks whether the people named in the QMS can do the work the procedures describe. The last block of the day is how Clauses 5 and 7 appear in that file, next to the technical processes, not as a separate HR pack.
Quality leads, managers who will be named in the accountability structure, and learning or HR partners who own QMS competence. Fundamentals or the two-day Overview are the usual prior days.
