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.
Install with Tessl CLI
npx tessl i github:alirezarezvani/claude-skills --skill qms-audit-expert99
Does it follow best practices?
Validation for skill structure
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 specialized domain (ISO 13485 medical device QMS auditing), lists concrete capabilities, and provides explicit 'Use for' guidance with natural trigger terms. The description uses proper third-person voice and maintains appropriate conciseness while covering all necessary elements for skill selection.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Lists multiple specific concrete actions: 'audit planning, execution, nonconformity classification, and CAPA verification' - these are distinct, actionable capabilities within the ISO 13485 domain. | 3 / 3 |
Completeness | Clearly answers both what ('audit planning, execution, nonconformity classification, CAPA verification') AND when ('Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management') with explicit trigger guidance. | 3 / 3 |
Trigger Term Quality | Includes natural keywords users would say: 'internal audit', 'audit planning', 'audit execution', 'finding classification', 'external audit preparation', 'audit program management', 'CAPA', 'nonconformity', 'medical device', 'QMS', 'ISO 13485'. | 3 / 3 |
Distinctiveness Conflict Risk | Highly specific niche combining ISO 13485, medical device QMS, and internal auditing - unlikely to conflict with other skills due to the specialized regulatory domain and explicit audit-focused triggers. | 3 / 3 |
Total | 12 / 12 Passed |
Implementation
100%Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.
This is an excellent skill file that demonstrates best practices across all dimensions. It provides comprehensive, actionable guidance for ISO 13485 auditing with clear workflows, validation checkpoints, and practical tools. The content respects Claude's intelligence while providing domain-specific knowledge that adds genuine value.
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | The content is lean and efficient, using tables and structured formats to convey information without explaining concepts Claude already knows. No unnecessary explanations of what ISO 13485 is or basic audit concepts. | 3 / 3 |
Actionability | Provides concrete, executable guidance including specific bash commands, JSON input formats, checklists, decision trees, and example finding documentation. The audit questions and classification criteria are immediately usable. | 3 / 3 |
Workflow Clarity | Each major workflow (planning, execution, nonconformity management, external prep) has numbered steps with explicit validation checkpoints. The classification decision tree provides clear feedback loops, and timelines are specified for CAPA closure. | 3 / 3 |
Progressive Disclosure | Well-organized with clear table of contents, appropriate inline content for quick reference, and one-level-deep references to detailed guides (iso13485-audit-guide.md, nonconformity-classification.md). Content is appropriately split between overview and reference materials. | 3 / 3 |
Total | 12 / 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 | |
- Reviewed
Table of Contents
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