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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.

69

Quality

87%

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SecuritybySnyk

Passed

No findings from the security scan

The canonical home for this skill is qms-audit-expert in alirezarezvani/claude-skills

SKILL.md
Quality
Evals
Security

Quality

Content

85%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.

A well-structured, highly actionable skill body with explicit validation checkpoints in every workflow, undermined by a broken bundle: all three referenced files (two references, one script) are missing from the skill directory. Conciseness is strong, with only minor duplication in the reference-documentation section.

Suggestions

Add the referenced bundle files (references/iso13485-audit-guide.md, references/nonconformity-classification.md, scripts/audit_schedule_optimizer.py) or remove the references and script instructions — currently the skill defers to content that does not exist.

Merge the 'Reference Documentation' section with the earlier inline 'See references/...' pointers to remove the duplicated signposting and tighten conciseness.

Add a brief error-recovery note for the script workflows (e.g. what to do when processes.json is malformed or a clause audit uncovers scheduling conflicts) to strengthen the feedback loop beyond terminal validation checks.

DimensionReasoningScore

Conciseness

The body is almost entirely tables, checklists, and templates with no padding explaining concepts Claude already knows, but the 'Reference Documentation' section repeats the inline 'See references/...' pointers made earlier in the body, a minor redundancy. Not 5 ('every token earns its place') because of that duplication; not 3 since there is no concept-explanation padding.

4 / 5

Actionability

Copy-paste-ready script invocations with flags ('python scripts/audit_schedule_optimizer.py --processes processes.json --output json'), a sample JSON input, clause-specific audit questions, and a fully worked finding-documentation example. Guidance is executable and covers the common cases, matching the top anchor.

5 / 5

Workflow Clarity

Four numbered multi-step workflows each end with a bolded explicit Validation checkpoint ('Validation: All ISO 13485 clauses covered within cycle'), reinforced by checklists (auditor independence, pre-audit readiness) and a classification decision tree for branching cases. This matches the anchor requiring explicit validation steps plus checklists for complex processes.

5 / 5

Progressive Disclosure

Sectioning and one-level-deep signposting are good ('See references/iso13485-audit-guide.md for complete question sets'), but the referenced bundle files do not exist — neither references/ nor scripts/ directories are present, so the deferred content (complete question sets, detailed classification guidance, the schedule optimizer) is unreachable. This is more than the 'minor organization gaps' of anchor 4 and less broken than anchor 2's buried/inlined mess, so it sits at 3.

3 / 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: concrete capability list, explicit and specific 'Use when' clause, and a well-delineated niche. The main gap is a handful of missing natural trigger variants (audit checklist, audit report, regulatory audit) that would push specificity and trigger coverage to the top anchor.

DimensionReasoningScore

Specificity

Covers audit planning, execution, nonconformity classification, and CAPA verification — several concrete actions with only minor gaps (reporting and scheduling appear only implicitly via 'managing an audit program'). The abstract opener 'internal audit expertise' and unlisted actions like audit reporting keep it just below the comprehensive anchor 5.

4 / 5

Completeness

Explicitly answers both: what — 'Covers audit planning, execution, nonconformity classification, and CAPA verification' — and when — 'Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.' This matches the anchor-5 pattern of concrete what + explicit trigger phrases; a score of 4 would require the 'when' to be less explicit than it is.

5 / 5

Trigger Term Quality

Natural phrases users would say are present ('internal audits', 'classifying findings', 'external audits', 'CAPA', 'audit program'), but a few common variants are missing from the description itself (e.g. 'audit checklist', 'audit report', 'regulatory audit'). Fits anchor 4 ('good keyword coverage; a few natural terms missing') better than 5, which requires synonym/extension-level comprehensiveness.

4 / 5

Distinctiveness Conflict Risk

'ISO 13485 internal audit expertise for medical device QMS' names a clear niche with distinct domain-specific triggers; overlap with other skills is minimal. Not 4, because the anchor-4 case ('minor overlap risk with closely related skills') does not apply — the ISO 13485/medical-device framing is highly discriminating.

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

frontmatter_unknown_keys

Unknown frontmatter key(s) found; consider removing or moving to metadata

Warning

referenced_paths_exist

Referenced path issues: 7 missing

Warning

Total

14

/

16

Passed

Repository

alirezarezvani/claude-skills

Path

.gemini/skills/qms-audit-expert/SKILL.md

Reviewed

Table of Contents

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