D2. Assessment Checklist Granular per-sub-requirement checklist mapping every requirement of Articles 8–15, Article 17, and Annex IV to specific questions, evidence expectations, and pass/fail criteria. Each sub-requirement of each article is a separate checklist item with its own evidence requirement. The AI System Assessor executes the checklist during the technical documentation assessment, recording evidence, determination (conformant, non-conformant, or partially conformant), and conditions for each item. Responsible party: Conformity Assessment Coordinator prepares. AI System Assessor executes. Regulations addressed: Articles 8–15 (all high-risk system requirements); Article 17 (QMS); Annex IV (technical documentation); Annex VI(b) (technical documentation assessment procedure). Key outputs

• Per-sub-requirement determination with evidence reference
• Summary conformity status per article