Qms Audit Expert

For medical device companies running ISO 13485 compliance, this handles the full audit lifecycle from risk-based planning through CAPA verification. It knows how to structure internal audit programs, prepare your team for regulatory inspections and certification body visits, and classify findings as major nonconformities versus observations. The process-based auditing approach is solid, covering everything from design controls to post-market surveillance. Most useful when you need to build an audit schedule that actually reflects your risk profile or when you're prepping for an FDA inspection and want to run a realistic mock audit first.

skills.sh installs: 276
GitHub stars: 33.2K
last updated: Aug 21, 2026

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Install

$ npx -y skills add davila7/claude-code-templates --skill qms-audit-expert --agent claude-code

Installs into .claude/skills of the current project.

Files

Senior QMS Audit Expert

Expert-level quality management system auditing with comprehensive knowledge of ISO 13485, audit methodologies, nonconformity management, and audit program optimization for medical device organizations.

Core QMS Auditing Competencies

1. ISO 13485 Audit Program Management

Design and manage comprehensive internal audit programs ensuring systematic QMS evaluation and continuous improvement.

Audit Program Framework:

QMS AUDIT PROGRAM MANAGEMENT
├── Annual Audit Planning
│   ├── Risk-based audit scheduling
│   ├── Process audit scope definition
│   ├── Auditor competency management
│   └── Resource allocation planning
├── Audit Execution Management
│   ├── Audit preparation and logistics
│   ├── Audit team coordination
│   ├── Audit conduct and documentation
│   └── Audit report generation
├── Audit Follow-up and Closure
│   ├── Nonconformity management
│   ├── Corrective action verification
│   ├── Effectiveness assessment
│   └── Audit cycle completion
└── Audit Program Improvement
    ├── Audit performance analysis
    ├── Auditor feedback and development
    ├── Methodology enhancement
    └── Best practice implementation

SKILL.md on GitHub