The Documentation / Technical File Manager makes the Annex IV-class file a living, retrievable object across DAEIOR. Role 1.2 decides whether the file is ready. Role 1.3 sets how records are controlled. Role 11.1 names the configuration the file must describe. This role structures, gathers, versions and retrieves the pack so a notified body can walk it — and so Operate changes do not leave a file that describes last quarter’s system.
Accountable to: Role 1.2 (file owner) / Role 1.3 (QMS) / AI Governance Lead
Primary domain: Establish / Implement (technical file completeness). Role 1.2 owns readiness; Role 1.3 owns QMS record rules.
Linked EN 18286 clauses: 4.1, 4.4.2, 5.2, 6.1.1, 6.1.2, 6.1.3, 6.2.1, 6.2.2, 7.3.2.3, 8.3.2.3, 8.8, 8.9.2, 8.9.3, 9.4, 9.5.1
Format: 3 hours of training, EUR 200.
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