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qms-audit-expert v1
ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.
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ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.
Manifest SHA-256
f1ebc81e50f2806ff1eedfc39bf01e44abd640827d15075ece2fce4c3af9b30e- SKILL.md9,724 bytes
- references/iso13485-audit-guide.md10,936 bytes
- references/iso13485_audit_playbook.md10,164 bytes
- references/nonconformity-classification.md6,894 bytes
- scripts/audit_schedule_optimizer.py13,719 bytes