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qms-audit-expert

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.

68

Quality

86%

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Passed

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SKILL.md
Quality
Evals
Security

Quality

Content

82%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is a well-structured, highly actionable audit methodology: concrete commands, literal audit questions, worked examples, decision trees, and explicit validation checkpoints in every workflow. The main weaknesses are an orphaned bundle file invisible to navigation, validation steps without error-recovery branches, and some duplication between inline content and the references.

Suggestions

Reference `references/iso13485_audit_playbook.md` from SKILL.md (e.g., in the Reference Documentation or Audit Execution sections) or remove it from the bundle — it is currently undiscoverable and also points to a nonexistent `compliance-os/scripts/audit_simulator.py`.

Add an error-recovery branch after each bolded **Validation:** step (e.g., what to do when clause coverage or evidence support fails), turning the terminal checkpoints into validate-fix-retry loops as in the external-audit and CAPA workflows.

Trim content duplicated between SKILL.md and the references — the classification criteria table and decision tree appear both inline and in `references/nonconformity-classification.md`; keep the inline version as a one-line summary pointing to the reference.

DimensionReasoningScore

Conciseness

The body is dense with domain knowledge Claude does not inherently have (risk-frequency table, clause-scope table, 30/60-day timelines) and never pads with basic explanations of what an audit or ISO standard is. It is not 5 because a few sections could be trimmed: the "Reference Documentation" section re-describes reference contents, the inline "Audit Questions by Clause" and sample JSON duplicate detail available in the references, and the closing metrics table is nice-to-have rather than essential.

4 / 5

Actionability

Guidance is fully concrete and executable: copy-paste bash invocations ("python scripts/audit_schedule_optimizer.py --processes processes.json --output json") that match the script's actual usage, literal interview questions ("Show me the document master list"), a fill-in finding template with a worked example (the overdue EQ-042 pH meter calibration), and a decision tree with specific timelines. This matches the anchor for copy-paste-ready commands with specific examples covering the common cases.

5 / 5

Workflow Clarity

Four workflows (planning, execution, nonconformity management, external audit prep) each present a clear 1-8 numbered sequence with an explicit bolded "**Validation:**" checkpoint, plus checklists (auditor independence, pre-audit readiness) and a CAPA closure loop ("Finding closed only after effective CAPA"). It falls between anchors 4 and 5: above 4's "minor validation gaps" because validations are explicit and checklists exist, but below 5 because no validation step includes an error-recovery branch (what to do when "All ISO 13485 clauses covered within cycle" fails), unlike the anchor-5 "if errors: fix and re-validate" pattern.

4 / 5

Progressive Disclosure

Good structure overall: a table of contents, well-signaled one-level-deep references ("See `references/iso13485-audit-guide.md` for complete question sets" plus a dedicated Reference Documentation section describing each file's contents), and detail appropriately pushed to references. It is not 5 because the bundle contains a third reference, `references/iso13485_audit_playbook.md`, that is never referenced from SKILL.md — its 7-phase workflow content is undiscoverable via the skill's navigation, and it in turn points to a nonexistent `compliance-os/scripts/audit_simulator.py`. It stays above anchor 3 because the references that are cited are clearly signaled, not buried.

4 / 5

Total

17

/

20

Passed

Description

87%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong description: it explicitly states what the skill does and when to use it, with concrete, domain-anchored capabilities and natural trigger phrases. The only refinements would be adding synonym triggers (CAPA, audit findings, audit schedule) and moving external-audit prep into the what-clause.

DimensionReasoningScore

Specificity

"Covers audit planning, execution, nonconformity classification, and CAPA verification" lists four concrete capabilities anchored to the "ISO 13485 internal audit expertise for medical device QMS" domain, matching the anchor for several specific actions with minor gaps. It is not 3 (more than 1-2 actions, all domain-specific rather than generic) and not 5 (the lead phrase "internal audit expertise" is a noun-phrase summary rather than a direct verb list, and external audit prep appears only in the when-clause, not the what).

4 / 5

Completeness

Both questions are explicitly answered: what — "Covers audit planning, execution, nonconformity classification, and CAPA verification"; when — "Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program" with concrete trigger phrases. This mirrors the anchor-5 exemplar's what+when structure, clearly above anchor 4 where the when is only weakly specified.

5 / 5

Trigger Term Quality

"Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program" supplies natural phrases users would say. Good keyword coverage but missing common variations such as "audit findings", "CAPA", "audit schedule", and "certification/regulatory audit" — matches anchor 4 rather than 5's comprehensive synonym coverage.

4 / 5

Distinctiveness Conflict Risk

"ISO 13485 internal audit expertise for medical device QMS" carves out a clear niche with distinct, audit-specific triggers, so conflict risk is minimal. It sits above anchor 4 (which involves minor overlap with closely related skills) because the ISO 13485/medical-device framing disambiguates from generic audit or ISO 9001/27001 audit skills; only a hypothetical sibling medical-device QMS skill would overlap.

5 / 5

Total

18

/

20

Passed

Validation

87%

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 14 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

metadata_version

'metadata.version' is missing

Warning

metadata_field

'metadata' should map string keys to string values

Warning

Total

14

/

16

Passed

Repository

alirezarezvani/claude-skills

Path

ra-qm-team/skills/qms-audit-expert/SKILL.md

Reviewed

Table of Contents

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