Verified:GitHub

qms-audit-expert

Plan and execute ISO 13485 internal audits for medical device QMS.

Updated Mar 4, 2026

Search Tags:#audit #compliance #risk management #medical device #qms #iso 13485 #capa

One-click install

npx skills add https://github.com/Tonybleything76/more-claude-skills --skill qms-audit-expert-tonybleything76

Or copy as Structured Prompt for Agent▼

Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/Tonybleything76/more-claude-skills/tree/main/ra-qm-team/qms-audit-expert
Command: npx skills add https://github.com/Tonybleything76/more-claude-skills --skill qms-audit-expert-tonybleything76

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires pandas, numpy, scipy, matplotlib, seaborn, and includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill streamlines the complex process of conducting internal audits for medical device Quality Management Systems (QMS) according to ISO 13485, ensuring compliance and identifying areas for improvement.

Core Features & Use Cases

Audit Planning: Develop risk-based audit schedules and scopes.
Audit Execution: Guide the systematic collection of evidence and classification of findings.
Nonconformity Management: Classify findings and integrate with CAPA processes.
External Audit Prep: Prepare for certification audits with readiness checklists.
Use Case: A Quality Manager needs to plan and execute the annual internal audit for their medical device company. They can use this Skill to generate an audit schedule, get guidance on questioning auditees, and classify any nonconformities found.

Quick Start

Use the qms-audit-expert skill to plan an internal audit for the design control process.

Frequently Asked Questions about qms-audit-expert

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I plan a risk-based internal audit schedule for ISO 13485 compliance?▼

This Skill guides systematic evidence collection during QMS audits and helps classify nonconformities, directly integrating findings into your CAPA processes for resolution.

What is the best way to prepare for an external ISO 13485 certification audit?▼

Yes, the Skill supports audit program management by facilitating risk-based scheduling and providing structured guidance for questioning auditees during the execution phase.

How do I classify nonconformities found during a medical device QMS audit?▼

You can classify nonconformities found during a medical device QMS audit using provided expertise that categorizes findings and integrates them directly with CAPA workflows.

Do I need Python data libraries to run ISO 13485 audit program management tasks?▼

Yes, running these ISO 13485 audit tasks requires Python data libraries including pandas, numpy, scipy, matplotlib, and seaborn to support data processing and visualization.