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qms-audit-expert

Plans and executes ISO 13485 internal audits for medical device quality management systems.

2|Updated Mar 13, 2026
Search Tags:#audit#compliance#quality management#medical device#qms#iso 13485#capa
One-click install
npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill qms-audit-expert-zhangzhang-111-i
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/zhangzhang-111-i/claude-skills111/tree/main/ra-qm-team/qms-audit-expert
Command: npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill qms-audit-expert-zhangzhang-111-i

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill provides a comprehensive framework for conducting internal audits of medical device Quality Management Systems (QMS) according to ISO 13485 standards, 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 and mock audit guidance.
  • Use Case: A Quality Manager needs to plan and execute a series of internal audits for their medical device QMS. This Skill provides the step-by-step methodology, checklists, and tools to ensure all ISO 13485 requirements are covered effectively and efficiently.

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 an internal audit for a medical device QMS based on ISO 13485?▼

ISO 13485 internal audit planning requires developing a risk-based audit schedule and defining specific scopes. This ensures systematic coverage of medical device QMS compliance requirements and identifies areas for process improvement.

What is the best way to classify nonconformities and manage CAPA during a QMS audit?▼

Classifying nonconformities during a QMS audit involves systematically evaluating findings against ISO 13485 requirements. These classifications are then directly integrated into your CAPA processes for effective quality assurance and issue resolution.

How should I prepare for an external ISO 13485 certification audit?▼

Preparing for an external ISO 13485 certification audit involves using readiness checklists and conducting mock audits. This verifies your QMS compliance, ensures documentation is complete, and validates that internal audit processes are robust.

Does a risk-based audit methodology work for medical device quality management systems?▼

A risk-based audit methodology works effectively for medical device quality management systems by prioritizing high-impact processes. This structured workflow ensures systematic quality assurance and focuses resources on critical ISO 13485 compliance areas.

How do I execute an ISO 13485 audit and collect evidence systematically?▼

Executing an ISO 13485 audit requires systematically collecting evidence through structured workflows. This methodology guides the audit process, ensures objective findings, and supports accurate nonconformity classification for medical device QMS compliance.

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