Conciseness

The body is dense and assumes domain knowledge — no padding explaining what ISO 13485 or a QMS is — but at ~420 lines it inlines substantial lookup-table material (record retention with QMSR caveats, sterilization validation standards, supplier performance metrics) that belongs in the reference files the skill itself defines. Efficient with some bulk that could be trimmed, which fits anchor 4 rather than the 'every token earns its place' of 5.

Actionability

Guidance is largely concrete and executable: document number format 'SOP-02-001-01' with approval-authority tables, supplier scoring bands ('>80: Approved'), finding classifications with response times ('30 days for CAPA'), and script flags ('--clause 7.3', '--audit-type system'). However, several workflows defer their detailed how-to (e.g., 'see iso13485-clause-requirements.md for detailed requirements and audit questions') to files that are not present in the bundle, leaving minor gaps. Not the pseudocode-level of 3, but not fully self-sufficient as the top anchor requires.

Workflow Clarity

All eight workflows have clearly numbered sequences, each ending in an explicit bolded '**Validation:**' checkpoint (e.g., 'Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved'), which exceeds anchor 4's 'most checkpoints present'. But the 5 anchor also requires feedback loops for error recovery attached to the workflow — recovery guidance exists only in detached sections (revalidation triggers, CAPA initiation criteria) rather than as in-workflow 'if validation fails, do X' steps, so 4 is the best fit.

Progressive Disclosure

The body itself is well structured as an overview — workflows and quick-reference tables inline, clearly signaled one-level-deep pointers to references/iso13485-clause-requirements.md, references/qms-process-templates.md, and scripts/qms_audit_checklist.py — which alone would merit 4 or 5. However, the actual bundle contains no references/, scripts/, or assets/ directories at all: every referenced path dangles, so following the disclosure chain leads to missing files and the deferred detail (clause-by-clause requirements, templates, the audit checklist generator) is unavailable. A fully broken reference chain is more than the 'minor organization gaps' of anchor 4, fitting the 'structure present but could be better organized' band of 3.

Specificity

The description lists five concrete capability areas — 'QMS design, documentation control, internal auditing, CAPA management, and certification support' — which comprehensively covers the ISO 13485 QMS domain. This matches the anchor for multiple specific concrete actions with comprehensive coverage; score 4 would require minor coverage gaps that are not present.

Completeness

It explicitly answers both questions: 'Provides QMS design, documentation control, internal auditing, CAPA management, and certification support' (what) and 'Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs' (when, with concrete trigger phrases). Clear match for the top anchor.

Trigger Term Quality

The 'Use when' clause contains natural phrasings users would say ('preparing for ISO 13485 audits', 'setting up corrective actions', 'medical device quality systems'), but the trailing 'Useful for quality management, audit preparation...' sentence repeats earlier terms rather than adding new synonyms (e.g., 'quality manual', 'internal audit', 'supplier qualification' are absent from the when-clause). Good keyword coverage with a few natural terms missing — not the comprehensive synonym coverage of a 5.

Distinctiveness Conflict Risk

The ISO 13485 / medical device QMS niche is distinct and the triggers are domain-specific, but the skill family it belongs to includes closely related skills (capa-officer, qms-audit-expert) whose territory overlaps triggers like 'setting up corrective actions' and 'internal audit'. Mostly distinct with minor overlap risk against closely related skills — not the minimal-conflict clarity of a 5.