Name: qms-audit-expert
Rating: 71.2 (1 reviews)
Author: alirezarezvani

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.

Quality

88%

Does it follow best practices?

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Securityby

Passed

No findings from the security scan

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

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.

The body is dense, actionable, and well-sequenced with explicit validation checkpoints across all four workflows. The main weakness is progressive disclosure: the body repeatedly points to reference files and a script that are not bundled, leaving the navigation pointing at missing targets.

Suggestions

Bundle the referenced files (references/iso13485-audit-guide.md, references/nonconformity-classification.md, scripts/audit_schedule_optimizer.py) or remove the references and inline the essential material, so signaled navigation resolves to real content.

Trim the redundant 'Reference Documentation' section, which re-describes the contents of files already cited inline.

Consider dropping the Table of Contents for a skill of this length; the section headers alone provide sufficient navigation.

Dimension	Reasoning	Score
Conciseness	Largely lean and information-dense — tables, numbered steps, and a decision tree carry the content with little concept re-explanation — but the redundant Table of Contents and the 'Reference Documentation' section re-describing files already pointed to inline could be trimmed.	4 / 5
Actionability	Fully executable guidance throughout: copy-paste script invocations ('python scripts/audit_schedule_optimizer.py --processes processes.json'), a concrete JSON input sample, per-clause audit questions, finding-documentation templates with a worked example, and a classification decision tree.	5 / 5
Workflow Clarity	Four multi-step workflows (planning, execution, nonconformity, external-audit prep) are each clearly numbered and terminate in an explicit 'Validation:' checkpoint, with checklists for auditor independence and pre-audit readiness providing feedback gates.	5 / 5
Progressive Disclosure	Sectioning is good and references to references/iso13485-audit-guide.md, references/nonconformity-classification.md, and scripts/audit_schedule_optimizer.py are clearly signaled, but none of these bundle files actually exist, so the one-level-deep navigation is broken rather than merely a minor gap.	3 / 5
	Total	17 / 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 strong, third-person description that clearly states capabilities and provides an explicit 'Use when' clause with concrete triggers. Minor room to surface a few more natural keyword variations (checklist, schedule) in the description body.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions — 'audit planning, execution, nonconformity classification, and CAPA verification' plus 'planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program' — giving comprehensive coverage of the skill's capabilities.	5 / 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') with concrete trigger phrases.	5 / 5
Trigger Term Quality	The description surfaces natural terms users would say ('internal audits', 'executing audits', 'classifying findings', 'external audits', 'audit program'), but a few common variations present in the trigger list ('audit checklist', 'audit schedule') are absent from the description body itself.	4 / 5
Distinctiveness Conflict Risk	The 'ISO 13485 internal audit expertise for medical device QMS' framing carves a clear niche with distinct, domain-specific triggers and minimal overlap risk with other skills.	5 / 5
	Total	19 / 20 Passed

Validation

87%

Warnings & errors only

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

Criteria	Description	Result
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
Commit: 19392f7

Reviewed: ~13 hours ago

Table of Contents

Discovery Implementation Validation

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