Conciseness

The body is lean checklist-style prose with zero explanation of what ISO 13485, CAPA, or DHF are — it assumes Claude's competence throughout. However, inline time-sensitive claims ("substantially harmonized post Feb 2026" on lines 15 and 129) are not placed in a deprecation/old-patterns note, which the guidelines say should penalize conciseness — anchor 4, not 5.

Actionability

Each of the six questions carries concrete evidence requirements ("5 Why minimum", "last 6 months", "Aging CAPAs > 90 days"), and the workflow gives runnable python commands with argument files. But two of four workflow steps are only "Route to ..." comments, and the referenced scripts (audit_schedule_optimizer.py, audit_simulator.py) live in other skills' directories with no bundle fallback — minor gaps consistent with anchor 4 rather than the copy-paste-complete anchor 5.

Workflow Clarity

A clear sequence exists: six ordered interrogation areas, a 4-step workflow with commands, and a full output template that functions as a checklist (pass/fail per DHF, per CAPA, yes/no per clause input). The work is read-only analysis, so the destructive/batch validation cap does not apply, but no explicit validate-and-recover checkpoint (e.g., what to do when sampled evidence is missing) exists — anchor 4, not 5.

Progressive Disclosure

Well-organized sections with one-level-deep, clearly signaled references ("Reference iso13485_audit_playbook.md for the per-DHF checklist", "per multi_framework_audit_playbook.md") plus a Routing and Related map to sibling skills. No bundle files ship alongside this SKILL.md, and the referenced playbooks live in external skill trees, so navigation depends on files outside this bundle — good but not the fully self-contained anchor 5.

Specificity

The description names concrete focus areas — "6-question forcing interrogation", "Design controls + CAPA + post-market focused" — rather than vague claims. It stops short of a fully comprehensive action list (no mention of process validation, risk management file, or management review), so it fits anchor 4 ('several specific actions; minor gaps') rather than 5.

Completeness

It explicitly answers 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. Not below 5 because neither half is missing or weakly implied.

Trigger Term Quality

Natural domain phrases are present: "Clause 8.2.4 internal audit", "MDR / FDA QSR alignment review", "product-launch DHF closure audit", "CAPA". A few natural variations users might say are missing (e.g., 'audit readiness', 'mock audit', 'notified body'), placing it at anchor 4 rather than 5, and clearly above anchor 3 since both regulatory regimes and lifecycle stages are covered.

Distinctiveness Conflict Risk

The ISO 13485 QMS audit niche is distinct with clear triggers, but the phrase "MDR / FDA QSR alignment review" overlaps the stated purpose of the sibling fda-qsr-auditor/fda-qsr-audit-prep skill referenced in the body, creating minor conflict risk — anchor 4, not 5.