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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.

72

Quality

90%

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SecuritybySnyk

The risk profile of this skill

SKILL.md
Quality
Evals
Security

Quality

Content

88%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, lean instruction skill with explicit validation checkpoints in every workflow and clean one-level-deep references. The only notable gap is an unreferenced bundle file (iso13485_audit_playbook.md) that breaks otherwise tidy navigation.

DimensionReasoningScore

Conciseness

Information-dense throughout — tables, checklists, numbered workflows, a decision tree, and code fences — with no padding or explanations of concepts Claude already knows; every line earns its place.

5 / 5

Actionability

Provides executable bash commands, sample JSON input, a finding-documentation template, and per-clause audit questions, but the script's own interface beyond the CLI flags is not shown inline, leaving a minor gap.

4 / 5

Workflow Clarity

Four multi-step workflows each end in an explicit "Validation:" checkpoint (e.g. "All ISO 13485 clauses covered within cycle"), with checklists and a classification decision tree providing clear feedback loops for these batch/program operations.

5 / 5

Progressive Disclosure

Body acts as an overview with bulk detail pushed to one-level-deep references (iso13485-audit-guide.md, nonconformity-classification.md) and a script, all clearly signaled and present on disk; minor gap is the orphaned references/iso13485_audit_playbook.md that is never linked from the body.

4 / 5

Total

18

/

20

Passed

Description

92%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 high-quality description: concise, third-person, concrete, and with an explicit "Use when" trigger clause covering the main invocation scenarios. Minor room to add a few synonymous natural terms, but it is already clearly distinguishable and complete.

DimensionReasoningScore

Specificity

Names the domain plus multiple concrete actions — "audit planning, execution, nonconformity classification, and CAPA verification" — giving comprehensive coverage of the skill's capabilities.

5 / 5

Completeness

Explicitly answers both "what" (ISO 13485 internal audit expertise covering the listed activities) and "when" ("Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program") with concrete trigger phrases.

5 / 5

Trigger Term Quality

Strong natural-phrase coverage in the "Use when" clause ("planning internal audits, executing audits, classifying findings, preparing for external audits"), but a few natural synonyms (e.g. regulatory audit, MDSAP) are missing, so it sits just below comprehensive.

4 / 5

Distinctiveness Conflict Risk

Clear narrow niche (ISO 13485 medical-device QMS internal audit) with domain-specific triggers, minimal overlap risk with other skills.

5 / 5

Total

19

/

20

Passed

Validation

93%

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

Validation15 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

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

Warning

Total

15

/

16

Passed

Repository
alirezarezvani/claude-skills
Reviewed

Table of Contents

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