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# ISO 13485:2016 Clause Requirements Detailed requirements for each ISO 13485:2016 clause with implementation guidance and audit criteria. --- ## Table of Contents - [Clause 4: Quality Management System](#clause-4-quality-management-system) - [Clause 5: Management Responsibility](#clause-5-management-responsibility) - [Clause 6: Resource Management](#clause-6-resource-management) - [Clause 7: Product Realization](#clause-7-product-realization) - [Clause 8: Measurement, Analysis and Improveme
How to Use
Recommended: Install to project (local)
mkdir -p .claude/skills
curl -o .claude/skills/iso13485-clause-requirements.md \
https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/quality-manager-qms-iso13485/references/iso13485-clause-requirements.mdSkill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.
Alternative: Clone full repo
git clone https://github.com/alirezarezvani/claude-skillsThen reference at ra-qm-team/quality-manager-qms-iso13485/references/iso13485-clause-requirements.md
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