Individual skill
quality-manager-qms-iso13485
Build or maintain an ISO 13485 medical device QMS: design, documentation, CAPA, audit prep. Use whenever the user faces a 13485 certification audit or needs quality procedures.
ra-qm-team/skills/quality-manager-qms-iso13485/SKILL.md
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SKILL.mdcore · 17,539 bytesSKILL.mdcore · 17,539 bytesreferences/iso13485-clause-requirements.mddoc · 23,690 bytesreferences/qms-process-templates.mddoc · 19,951 bytesscripts/qms_audit_checklist.pyruns · 30,185 bytes
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# Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.
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## Table of Contents
- [QMS Implementation Workflow](#qms-implementation-workflow)
- [Document Control Workflow](#document-control-workflow)
- [Internal Audit Workflow](#internal-audit-workflow)
- [Process Validation Workflow](#process-validation-workflow)
- [Supplier Qualification Workflow](#supplier-qualification-workflow)
- [QMS Process Reference](#qms-process-reference)