Name: quality-manager-qms-iso13485
Rating: 66.4 (1 reviews)
Author: alirezarezvani

quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. 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. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

Quality

81%

Does it follow best practices?

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Securityby

Passed

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The canonical home for this skill is quality-manager-qms-iso13485 in alirezarezvani/claude-skills

Quality

Content

71%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.

Well-structured, actionable QMS guidance with explicit validation checkpoints and useful decision frameworks, undermined by a progressive-disclosure failure: all referenced bundle files (two reference docs and one script) are missing, so the SKILL.md carries content monolithically and its links are dead.

Suggestions

Ship the referenced bundle files (references/qms-process-templates.md, references/iso13485-clause-requirements.md, scripts/qms_audit_checklist.py) or remove the links and inline the essential content directly.

Add explicit error-recovery loops to the workflows (e.g., 'If a Validation checkpoint is not met, return to the relevant step and re-run it') to lift workflow clarity.

Tighten the QMSR-transition and decision-discipline callouts to the minimum needed for safe citation, reducing token weight without losing the regulatory guardrail.

Dimension	Reasoning	Score
Conciseness	Dense, table-driven content that assumes Claude's competence (no preamble on what ISO 13485 or sterilization is), but the ~420-line body and verbose callouts (QMSR transition note, decision-discipline block) carry tokens that could be trimmed.	4 / 5
Actionability	Workflows give copy-ready specifics (numbering format "SOP-02-001-01", supplier score thresholds ">80: Approved, 60-80: Conditional", retention periods, finding response times), but the referenced script and reference files do not exist, leaving a gap in executable follow-through.	4 / 5
Workflow Clarity	Each workflow is a clearly numbered sequence ending in a bolded "Validation:" checkpoint with supporting checklists and a decision tree, but explicit error-recovery feedback loops ("if validation fails, return to step X") are not spelled out.	4 / 5
Progressive Disclosure	Structure and inline reference signaling are good (ToC, "Tools and References" section, one-level-deep links), but every referenced target — references/qms-process-templates.md, references/iso13485-clause-requirements.md, scripts/qms_audit_checklist.py — is absent from the bundle, so navigation resolves to nothing and detailed content is forced inline.	3 / 5
	Total	15 / 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 explicit use-conditions with concrete trigger phrases. The only weakness is mild redundancy in the closing "Useful for..." sentence rather than richer synonym coverage.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete capabilities — "QMS design, documentation control, internal auditing, CAPA management, and certification support" — giving comprehensive coverage of the domain's actions rather than vague abstractions.	5 / 5
Completeness	Explicitly answers both what ("ISO 13485 QMS implementation and maintenance...Provides QMS design, documentation control, internal auditing, CAPA management, and certification support") and when ("Use when working with medical device quality systems, preparing for ISO 13485 audits...") with concrete trigger phrases.	5 / 5
Trigger Term Quality	The "Use when..." clause surfaces natural phrases ("ISO 13485 audits", "corrective actions", "audit preparation", "regulatory compliance documentation"), but the closing sentence largely repeats those terms rather than adding fresh synonyms or variants.	4 / 5
Distinctiveness Conflict Risk	Occupies a clear niche (ISO 13485 medical-device QMS) with distinct, domain-specific triggers, making accidental firing for unrelated skills unlikely.	5 / 5
	Total	19 / 20 Passed

Validation

81%

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 — 13 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning
relative_links	Relative link issues: 6 missing, 5 suspicious	Warning
referenced_paths_exist	Referenced path issues: 6 missing	Warning

	Total	13 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: .gemini/skills/quality-manager-qms-iso13485/SKILL.md
Commit: 19392f7

Reviewed: ~2 hours ago

Table of Contents

Discovery Implementation Validation

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