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qms-audit-expert

Automate ISO 13485 internal audit planning and execution for medical device QMS compliance.

Updated Mar 21, 2026
Search Tags:#audit#compliance#iso13485#internal-audit#qms#capa#nonconformity
One-click install
npx skills add https://github.com/AgLyx3/My-Note-App-Not-Just-a-Note-App --skill qms-audit-expert-aglyx3
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/AgLyx3/My-Note-App-Not-Just-a-Note-App/tree/main/.cursor/skills/ra-qm-team/qms-audit-expert
Command: npx skills add https://github.com/AgLyx3/My-Note-App-Not-Just-a-Note-App --skill qms-audit-expert-aglyx3

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

ISO 13485 internal audit methodology and framework to plan, execute, classify findings, and verify CAPA for medical device QMS compliance.

Core Features & Use Cases

  • Audit Planning Workflow
  • Audit Execution
  • Nonconformity Management
  • External Audit Preparation
  • Reference Documentation
  • Tools and templates Use cases include internal audit planning, audit execution, finding classification, external audit preparation, and audit program management.

Quick Start

Ask your AI to generate a complete ISO 13485 internal audit plan for a medical device QMS, including schedule, evidence templates, and CAPA follow-ups.

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 ISO 13485 internal audit for a medical device QMS?▼

An ISO 13485 internal audit for a medical device QMS requires a structured workflow covering scheduling, evidence collection templates, and finding classification. This framework automates audit planning and execution to ensure comprehensive compliance.

What is the best way to classify nonconformities found during a QMS audit?▼

The best way to classify nonconformities during a QMS audit is using a structured finding classification framework. This ensures consistent severity categorization and directly links findings to necessary CAPA tracking for compliance closure.

How does CAPA verification work after an internal audit?▼

CAPA verification after an internal audit works by tracking corrective and preventive actions against classified nonconformities. The framework integrates evidence collection and CAPA follow-up to validate that identified QMS deficiencies are effectively resolved.

Can I use this framework to prepare for external ISO 13485 audits?▼

Yes, you can use this framework to prepare for external ISO 13485 audits. It includes external audit preparation features by validating your internal evidence collection, finding classification, and CAPA tracking before external review.

Do I need predefined templates to execute medical device compliance audits?▼

You need predefined templates to execute medical device compliance audits because structured evidence collection is required. This framework provides the necessary tools and reference documentation to standardize your audit execution and program management.

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