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qms-audit-expert

Plan and execute ISO 13485 internal audits with nonconformity classification and CAPA verification.

Updated Mar 5, 2026
Search Tags:#audit#compliance#qms#capa#iso-13485#nonconformity
One-click install
npx skills add https://github.com/theandyalvarez7-ruby/claude-skills --skill qms-audit-expert-theandyalvarez7-ruby
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/theandyalvarez7-ruby/claude-skills/tree/main/ra-qm-team/qms-audit-expert
Command: npx skills add https://github.com/theandyalvarez7-ruby/claude-skills --skill qms-audit-expert-theandyalvarez7-ruby

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Medical device companies often struggle to plan, execute, and document ISO 13485 internal audits, classify nonconformities consistently, and verify CAPA effectiveness across the QMS.

Core Features & Use Cases

  • Structured audit planning and execution templates aligned to ISO 13485 clauses.
  • Nonconformity classification guidance and CAPA integration to streamline closure.
  • Reference materials and an optimization tool (audit schedule) to balance audit load and coverage across processes.

Quick Start

Run the audit schedule optimizer against a JSON file of processes to generate a schedule.

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?▼

Plan an ISO 13485 internal audit using structured templates aligned to specific clauses and an audit schedule optimizer script that processes a JSON file of processes to generate a balanced schedule.

What is the process for classifying nonconformities during a QMS audit?▼

Classifying nonconformities during a QMS audit involves structured execution templates and guidance that integrate directly with CAPA processes to streamline closure and verify effectiveness.

How do I verify CAPA effectiveness after an ISO 13485 audit?▼

Verify CAPA effectiveness after an ISO 13485 audit through structured workflows that classify nonconformities and enforce reference documentation for practical closure verification.

Can I optimize the audit schedule across multiple QMS processes?▼

You can optimize the audit schedule across QMS processes by running the included audit schedule optimizer script against a JSON file of processes to balance audit load and coverage.

Does this support external audit preparation for medical device compliance?▼

It supports external audit preparation for medical device compliance by enforcing structured internal audit processes, reference documentation, and consistent nonconformity classification.

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