Conciseness

The body is a dense, clause-anchored checklist with minimal padding ('Root cause analysis depth: 5 Why minimum', 'Aging CAPAs > 90 days: N'). Minor trims are possible — the intro sentence repeats the description and the Routing/Related sections partially overlap — matching anchor 4 ('efficient; minor instances of over-explanation that could be trimmed') rather than anchor 5.

Actionability

The six questions give concrete, clause-level checklists and the Output Format is a fully specified template, so most guidance is executable. It falls short of anchor 5 because Workflow steps 3 and 4 are only routing comments ('Route to ... tools') with no commands, and path conventions are inconsistent ('../../skills/compliance-os/scripts/audit_simulator.py' vs '${CLAUDE_PLUGIN_ROOT}/vendor/...').

Workflow Clarity

The Workflow section lists a numbered sequence, but steps 3–4 are vague routing comments, paths use two different conventions, and there are no validation checkpoints (the verdict criteria exist only in the Output Format template). This matches anchor 3 ('steps listed but validation gaps') rather than anchor 4, which requires most checkpoints present. The destructive-operation cap does not apply since this is a read-only audit skill.

Progressive Disclosure

Sections are well organized and playbook references are clearly signaled with purpose ('Reference `iso13485_audit_playbook.md` for the per-DHF checklist') and are one level deep. Below anchor 5 because no bundle files exist alongside this SKILL.md to verify the referenced playbooks/scripts, and the full output template is inlined rather than referenced.

Specificity

Names the domain ('ISO 13485 QMS audit') and concrete focus areas ('6-question forcing interrogation', 'Design controls + CAPA + post-market focused'), which matches the 'several specific actions; minor gaps' anchor. It is below anchor 5 because it describes an approach and focus areas rather than a comprehensive list of actions.

Completeness

Explicitly answers both what ('ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused.') and when ('Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit.') with concrete trigger phrases, matching anchor 5. Anchor 4 does not fit because the 'when' clause is fully explicit rather than improvable.

Trigger Term Quality

Natural keywords a user would say are present ('ISO 13485', 'QMS audit', 'internal audit', 'MDR', 'FDA QSR', 'DHF closure audit'), giving good coverage. Below anchor 5 because common variations like 'medical device', 'quality management system', or 'regulatory audit' are missing.

Distinctiveness Conflict Risk

Has a clear ISO 13485 QMS audit niche with distinct triggers, but 'MDR / FDA QSR alignment review' overlaps with a sibling FDA-QSR audit skill's trigger space, matching anchor 4 ('mostly distinct; minor overlap risk with closely related skills') rather than anchor 5.