qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
92
92%
Does it follow best practices?
Impact
92%
1.10xAverage score across 6 eval scenarios
Passed
No known issues
Quality
Discovery
100%Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.
This is a strong skill description that clearly defines its domain (ISO 13485 medical device QMS auditing), lists specific capabilities, and provides explicit trigger conditions via a 'Use for...' clause. The description is concise, uses third-person voice, and includes domain-specific terminology that practitioners would naturally use. It scores well across all dimensions with minimal room for improvement.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: audit planning, execution, nonconformity classification, CAPA verification, finding classification, external audit preparation, and audit program management. | 3 / 3 |
Completeness | Clearly answers both 'what' (audit planning, execution, nonconformity classification, CAPA verification) and 'when' with an explicit 'Use for...' clause listing five trigger scenarios. | 3 / 3 |
Trigger Term Quality | Includes strong natural keywords users would say: 'internal audit', 'ISO 13485', 'medical device', 'QMS', 'nonconformity', 'CAPA', 'finding classification', 'external audit preparation', 'audit program management'. These are terms practitioners naturally use. | 3 / 3 |
Distinctiveness Conflict Risk | Highly distinctive with a clear niche: ISO 13485 medical device QMS internal auditing. The combination of the specific standard, domain (medical device), and activity (internal audit) makes it very unlikely to conflict with other skills. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
85%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This is a strong, well-structured skill that provides highly actionable guidance for ISO 13485 internal auditing. The workflows are clearly sequenced with validation checkpoints, the classification decision tree is particularly effective, and progressive disclosure is well-handled. The main weakness is moderate verbosity—some sections could be tightened without losing clarity, particularly the reference documentation descriptions and tool output descriptions.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The content is generally well-structured with tables and checklists, but includes some unnecessary verbosity. The audit questions section could be more concise, and some explanatory text (e.g., describing what reference files contain) adds tokens without much value. The sample process input JSON and tool descriptions are somewhat padded. | 2 / 3 |
Actionability | The skill provides highly concrete, actionable guidance: specific classification criteria with decision trees, checklists with checkboxes, finding documentation templates with real examples, CLI commands for tooling, structured tables with timelines and criteria. The finding documentation example with the pH meter is excellent and copy-paste ready. | 3 / 3 |
Workflow Clarity | Each major workflow (planning, execution, nonconformity management, external prep) has clearly numbered steps with explicit validation checkpoints at the end. The nonconformity classification includes a decision tree for severity assignment, and the CAPA integration table provides clear feedback loops with verification timelines. Finding closure requires effective CAPA verification. | 3 / 3 |
Progressive Disclosure | The skill has a clear table of contents, well-organized sections, and appropriately references external files (iso13485-audit-guide.md, nonconformity-classification.md) for detailed content. References are one level deep and clearly signaled with descriptions of what each contains. The main document serves as a comprehensive but navigable overview. | 3 / 3 |
Total | 11 / 12 Passed |
Validation
90%Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.
Validation — 10 / 11 Passed
Validation for skill structure
| Criteria | Description | Result |
|---|---|---|
frontmatter_unknown_keys | Unknown frontmatter key(s) found; consider removing or moving to metadata | Warning |
Total | 10 / 11 Passed | |
- Repository
- alirezarezvani/claude-skills
- Commit
f567c61
- Reviewed
Table of Contents
Is this your skill?
If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.