QMS Audit Expert
QMS Audit Expert provides ISO 13485 internal audit methodology for medical device quality management systems. It guides users through audit planning, execution, nonconformity classification, and CAPA verification, and includes tools for generating risk-based audit schedules.
✨ What it does
- Risk-based audit frequency assignment (High/Medium/Low)
- Auditor independence verification checklist
- Clause-specific audit questions and evidence collection methods
- Nonconformity classification decision tree
- External audit readiness checklist and mock audit protocol
- Audit schedule optimizer script
🎯 When to use it
- Planning internal audits for ISO 13485 compliance
- Executing audits and collecting evidence
- Classifying audit findings as Major, Minor, or Observation
- Preparing for external certification or regulatory audits
- Managing an audit program and tracking metrics
🚀 How to use
Trigger by asking for help with ISO 13485 audits, internal audits, audit planning, nonconformity classification, or CAPA verification. Provide details such as processes to audit, risk levels, previous findings, or audit scope. Example prompts:
Help me plan an internal audit for our design control process.
Classify this finding: calibration overdue for pH meter.
Generate an audit schedule for our QMS processes.
📄 Output: The skill produces audit plans, schedules, checklists, finding documentation, and classification guidance.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/qms-audit-expert .claude/skills/qms-audit-expertSkill source: ra-qm-team/skills/qms-audit-expert/SKILL.md
⚠️ Good to know
Requires access to reference files (iso13485-audit-guide.md, nonconformity-classification.md) and Python environment for the optimizer script.
❓ FAQ
How are audit findings classified?
Findings are classified as Major, Minor, or Observation based on criteria such as systematic failure, impact on product safety, and recurrence. Major findings require CAPA within 30 days, Minor within 60 days, and Observations are optional.
What is the recommended audit frequency for high-risk processes?
High-risk processes such as design control, CAPA, and production validation should be audited quarterly.
How do I verify auditor independence?
Ensure the auditor is not responsible for the area being audited, has no direct reporting relationship to the auditee, and was not involved in recent activities under audit.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.