Individual skill
quality-manager-qmr
Use for QMR duties under ISO 13485 5.5.2: management review, quality policy and objectives, quality KPIs and cost of quality. Tracks reviews with management_review_tracker.py and monitors effectiveness with quality_effectiveness_monitor.py.
ra-qm-team/skills/quality-manager-qmr/SKILL.md
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SKILL.mdcore · 18,549 bytesSKILL.mdcore · 18,549 bytesSKILL.mdcore · 18,549 bytesreferences/management-review-guide.mddoc · 10,296 bytesreferences/quality-kpi-framework.mddoc · 11,786 bytesscripts/management_review_tracker.pyruns · 19,492 bytesscripts/quality_effectiveness_monitor.pyruns · 19,297 bytes
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# Senior Quality Manager Responsible Person (QMR)
Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.
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## Table of Contents
- [QMR Responsibilities](#qmr-responsibilities)
- [Management Review Workflow](#management-review-workflow)
- [Quality KPI Management Workflow](#quality-kpi-management-workflow)
- [Quality Objectives Workflow](#quality-objectives-workflow)
- [Quality Culture Assessment Workflow](#quality-culture-assessment-workflow)
- [Regulatory Compliance Oversight](#regulatory-compliance-oversight)