fix(skill): rewrite qms-audit-expert with comprehensive ISO 13485 audit content (#78) (#150)
- Remove placeholder files (example.py, api_reference.md, example_asset.txt)
- Add trigger phrases for skill discoverability (10 triggers)
- Add Table of Contents for navigation
- Create 4 numbered workflows with validation checkpoints:
- Audit Planning Workflow with risk-based frequency matrix
- Audit Execution with evidence collection methods
- Nonconformity Management with classification decision tree
- External Audit Preparation with readiness checklist
- Create iso13485-audit-guide.md (~380 lines):
- Clause-by-clause audit methodology (4.x through 8.x)
- Sample audit questions for each clause
- Evidence collection requirements
- Top 10 common ISO 13485 findings
- Create nonconformity-classification.md (~220 lines):
- Severity classification criteria and decision tree
- Impact vs occurrence matrix
- CAPA integration requirements
- Finding documentation templates
- Closure requirements by severity
- Create audit_schedule_optimizer.py (~420 lines):
- Risk-based priority scoring (risk 40%, overdue 30%, findings 20%, criticality 10%)
- Quarterly audit distribution
- Interactive mode for manual entry
- JSON and text output formats
- Recommendations engine for audit program improvement
SKILL.md grew from 239 to 324 lines with real audit methodology content.
Co-authored-by: Claude Opus 4.5 <noreply@anthropic.com>
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