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

89%

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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.

A well-structured, highly actionable QMS reference with clear workflows, validation checkpoints, and properly linked bundle files. Main gaps are explicit error-recovery feedback loops and some inline content that could be offloaded to references.

Suggestions

Add an explicit feedback loop to each workflow's validation step (e.g., 'If validation fails: review errors, fix, and re-run validation before proceeding') to lift workflow_clarity toward 5.

Move the dense inline tables (document numbering convention, area codes, supplier scoring criteria) into references/qms-process-templates.md and link to them, slimming the body and improving progressive_disclosure.

Condense the QMSR transition status block to the essential citation guidance; the current version is long for what is effectively a deprecation note.

Dimension	Reasoning	Score
Conciseness	Mostly efficient and information-dense (tables, numbered steps) without explaining concepts Claude already knows, but at 439 lines some inline reference tables and the lengthy QMSR status block could be trimmed; not a 5 due to that length.	4 / 5
Actionability	Fully executable guidance: concrete numbering conventions ('SOP-02-001-01'), specific script invocations ('python qms_audit_checklist.py --clause 7.3'), scoring formulas, finding-classification criteria, and a rendered decision tree covering common cases.	5 / 5
Workflow Clarity	Each workflow has a numbered sequence with an explicit 'Validation:' checkpoint, so destructive/batch caps do not apply; however, explicit 'validate → fix → re-validate' feedback loops are largely implicit rather than spelled out, holding it below 5.	4 / 5
Progressive Disclosure	Good structure with a table of contents and well-signaled one-level-deep references to real files (references/iso13485-clause-requirements.md, references/qms-process-templates.md, scripts/qms_audit_checklist.py), though the body still inlines substantial quick-reference material that could live in the bundle.	4 / 5
	Total	17 / 20 Passed

Description

96%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, specific description that clearly states capabilities and trigger conditions for an ISO 13485 medical-device QMS skill. The only weakness is a mildly redundant trailing sentence that broadens overlap risk slightly.

Suggestions

Drop the final 'Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.' sentence — it restates the 'Use when' triggers and dilutes the distinct ISO 13485 medical-device niche.

Tighten by merging the redundant synonyms into the existing 'Use when' clause to remove padding without losing trigger coverage.

Dimension	Reasoning	Score
Specificity	Lists multiple specific concrete actions — 'QMS design, documentation control, internal auditing, CAPA management, and certification support' — giving comprehensive coverage of the skill's capabilities.	5 / 5
Completeness	Explicitly answers both what ('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	Comprehensive natural-term coverage including synonyms and shorthand: 'ISO 13485', 'QMS', 'medical device quality systems', 'audits', 'regulatory compliance documentation', 'corrective actions', and 'audit preparation'.	5 / 5
Distinctiveness Conflict Risk	The ISO 13485 medical-device framing carves a clear niche, but the trailing 'Useful for quality management, audit preparation, regulatory compliance...' sentence is generic and creates minor overlap risk with broader quality/audit skills; not a 5 because of that breadth.	4 / 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
relative_links	Relative link issues: 5 suspicious	Warning

	Total	14 / 16 Passed

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

Reviewed: ~24 hours ago

Table of Contents

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