Real file from a public repo · synced Aug 27, 2026
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.
Works with
Install in three steps
- 1
Download the ZIP
One file per agent, plus INSTALL.md with the exact paths below.
- 2
Claude Code: copy SKILL.md into your skills folder
.claude/skills/quality-manager-qms-iso13485/SKILL.md # this project ~/.claude/skills/quality-manager-qms-iso13485/SKILL.md # every project
- 3
Other agents: use the matching file
skill.mdc goes in Cursor’s .cursor/rules/. AGENTS.md works as GitHub Copilot instructions, a legacy .cursorrules, or a Codex / Gemini CLI instructions file.
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