qms-audit-expert
CommunityMaster ISO 13485 QMS Audits
AuthorFantasia1999
Version1.0.0
Installs0
System Documentation
What problem does it solve?
This Skill streamlines the complex process of conducting internal audits for medical device Quality Management Systems (QMS) according to ISO 13485, ensuring compliance and identifying areas for improvement.
Core Features & Use Cases
- Audit Planning: Develop risk-based audit schedules and scope.
- Audit Execution: Guide through evidence collection and finding classification.
- Nonconformity Management: Assist in classifying and managing audit findings, including CAPA integration.
- External Audit Prep: Prepare your organization for certification or regulatory audits.
Quick Start
Use the qms-audit-expert skill to plan an internal audit for the design control process.
Dependency Matrix
Required Modules
python
Components
scriptsreferences
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: qms-audit-expert Download link: https://github.com/Fantasia1999/claude-skills-zh/archive/main.zip#qms-audit-expert Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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