qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.
Profile →npx skills add alirezarezvani/claude-skills --skill qms-audit-expert --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# QMS Audit Expert ISO 13485 internal audit methodology for medical device quality management systems. --- ## Table of Contents - [Audit Planning Workflow](#audit-planning-workflow) - [Audit Execution](#audit-execution) - [Nonconformity Management](#nonconformity-management) - [External Audit Preparation](#external-audit-preparation) - [Reference Documentation](#reference-documentation) - [Tools](#tools) --- ## Audit Planning Workflow Plan risk-based internal audit program: 1. List all QMS processes requiring audit 2. Assign risk level to each process (High/Medium/Low) 3. Review previous audit findings and trends 4. Determine audit frequency by risk level 5. Assign qualified auditors (verify independence) 6. Create annual audit schedule 7. Communicate schedule to process owners 8. **Validation:** All ISO 13485 clauses covered within cycle ### Risk-Based Audit Frequency | Risk Level | Frequency | Criteria | |------------|-----------|----------| | High | Quarterly | Design control, CAPA, production validation | | Medium | Semi-annual | Purchasing, training, document control | | Low | Annual | Infrastructure, management review (if stable) | ### Audit Scope by Clause | Clause | Process
- Table of Contents
- Audit Planning Workflow
- Risk-Based Audit Frequency
- Audit Scope by Clause
- Auditor Independence
- Audit Execution
- Evidence Collection
- Audit Questions by Clause
- Finding Documentation
- Nonconformity Management
- Classification Criteria
- Classification Decision
- CAPA Integration
- External Audit Preparation
Generate optimized audit schedule python scripts/audit_schedule_optimizer.py --processes processes.json Interactive mode python scripts/audit_schedule_optimizer.py --interactive JSON output for integration python scripts/audit_schedule_optimizer.py --processes processes.json --output json
What does the qms-audit-expert skill do?
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill qms-audit-expert --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.