Individual skill
qms-audit-expert
Use for ISO 13485 internal audits: planning the program, running an audit, classifying findings or preparing for an external audit. Optimizes the schedule with audit_schedule_optimizer.py.
ra-qm-team/skills/qms-audit-expert/SKILL.md
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SKILL.mdcore · 9,824 bytesSKILL.mdcore · 9,824 bytesreferences/iso13485-audit-guide.mddoc · 10,936 bytesreferences/iso13485_audit_playbook.mddoc · 10,164 bytesreferences/nonconformity-classification.mddoc · 6,894 bytesscripts/audit_schedule_optimizer.pyruns · 13,719 bytes
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# QMS Audit Expert
ISO 13485 internal audit methodology for medical device quality management systems.
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## Table of Contents
- [Audit Planning Workflow](#audit-planning-workflow)
- [Audit Execution](#audit-execution)
- [Nonconformity Management](#nonconformity-management)
- [External Audit Preparation](#external-audit-preparation)
- [Reference Documentation](#reference-documentation)
- [Tools](#tools)