Role 12.1: AI Documentation / Technical File Manager

Role 12.1: AI Documentation / Technical File Manager

  • Trainer: DP Schemes
  • Released: 2026-10-22 18:08:21
  • Level: Basic
  • Duration:

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.

Standing duties

  • Establish the technical-file map: what artefact, from which DAEIOR process, owned by whom, retained how long, linked to which baseline.
  • Keep the file current with the live baseline Role 11.1 names. A complete file of an obsolete bundle is a defect.
  • Raise ACT02 when documentation would describe a purpose the signed purpose does not authorise. Raise ACT03 when production has no current file.
  • Serve Role 1.2, Role 8.6 and Role 10.1 from the same pack — no parallel binder for the authority.
  • Do not treat a populated template, a model card or a slide annex as readiness, residual-risk acceptance or assurance.

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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