quality-manager-qms-iso13485
by alirezarezvani (GitHub) in alirezarezvani/claude-skills
What it does
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, managi
Quoted from the skill's SKILL.md under its MIT license.
Install
git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git /tmp/claude-skills mkdir -p ~/.claude/skills/ cp -r /tmp/claude-skills/ra-qm-team/skills/quality-manager-qms-iso13485 ~/.claude/skills/quality-manager-qms-iso13485
The command copies the skill from the author's repo. SkillTrove does not host it.
Files
- SKILL.md
- references/iso13485-clause-requirements.md
- references/qms-process-templates.md
- scripts/qms_audit_checklist.py
Source: https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/quality-manager-qms-iso13485. Checked 2026-10-13.
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