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quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

v1.0.01 install
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skills-hub.ai distributor
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Distributor-signed by skills-hub.aiCryptographically signed by the skills-hub.ai distributor key at publish time.
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Install this skill

Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.

npx @skills-hub-ai/cli install alirezarezvani-quality-manager-qms-iso13485
Or download directly:
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Setup by platform

Claude Code

~/.claude/skills/<skill>/SKILL.md

Setup guide →

Install

One-click setup for your editor

Run in your project root

npx @skills-hub-ai/cli install alirezarezvani-quality-manager-qms-iso13485 --target claude-code

Instructions

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