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D1. Assessment Plan Defines the conformity assessment scope, methodology, assessor team, assessment phases, and timeline. Specifies the three workstreams: QMS assessment (Annex VI(a)), technical documentation assessment (Annex VI(b)), and consistency assessment. Prepared by the Conformity Assessment Coordinator before the formal assessment begins. Specifies evidence to be reviewed, assessment criteria per article and sub-requirement, and expected duration per phase. Responsible party: Conformity Assessment Coordinator drafts. AI Governance Lead approves. Regulations addressed: Article 43 (conformity assessment procedures); Annex VI (internal control procedure); Annex VII (notified body procedure, where applicable). Key outputs

  • Three-workstream assessment structure with timeline
  • Per-article evidence mapping
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