qms-audit-expert

Plan and execute ISO 13485 audits with nonconformity handling and corrective action verification.

52|6|Updated Nov 24, 2025

Search Tags:#audit #compliance #CAPA #QMS #ISO 13485

Ready to run

npx skills add https://github.com/ovachiever/droid-tings --skill qms-audit-expert

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/ovachiever/droid-tings/tree/main/skills/qms-audit-expert
Command: npx skills add https://github.com/ovachiever/droid-tings --skill qms-audit-expert

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

Provide ISO 13485 audit expertise, risk-based planning, CAPA integration, and audit improvement for medical device companies.

Core Features & Use Cases

Audit program management and risk-based planning
Nonconformity identification and CAPA integration
Audit execution guidance and documentation

Quick Start

Start with a risk-based audit plan for ISO 13485.

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 for ISO 13485 compliance?▼

Risk-based audit planning for ISO 13485 involves identifying critical processes, assessing audit frequency by risk level per clause 8.2.2, scheduling audits across the quality management system, and documenting the audit program. This Skill guides you through planning that prioritizes high-risk areas and ensures systematic coverage of your medical device QMS.

What's the process for identifying and documenting nonconformities during QMS audits?▼

Nonconformity identification involves collecting objective evidence during audit execution, classifying findings by severity and impact on device quality, documenting root causes, and linking them to CAPA (corrective and preventive action) activities. This Skill provides frameworks for systematic nonconformity documentation and ensures traceability to corrective actions.

How do I verify that corrective actions actually address audit findings?▼

Corrective action verification requires reviewing implementation evidence, confirming actions target root causes, testing effectiveness in the operating environment, and documenting closure. This Skill guides follow-up audits and verification methods to confirm nonconformities are resolved and prevent recurrence.

Can I use this for preparing external audits by notified bodies?▼

Yes. External audit preparation includes readiness assessments, evidence organization, auditor competency evaluation, and mock audit execution. This Skill helps you align internal processes with external audit expectations and strengthen your audit response for regulatory bodies assessing ISO 13485 compliance.

What auditor competency and qualifications does ISO 13485 require?▼

ISO 13485 clause 8.2.1 requires auditors to be competent, independent, and trained on audit techniques. Competency includes knowledge of medical device regulations, quality systems, and audit methodology. This Skill helps you define competency criteria, plan auditor training, and maintain qualification records for your audit program.

How do I collect and organize audit evidence in a medical device QMS?▼

Evidence collection involves identifying objective proof of conformity or nonconformity, documenting sources, timestamps, and relevant personnel, and organizing records by process and risk area. This Skill provides evidence-gathering templates and documentation methods to support audit findings and regulatory inspections.