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.
Target: Target not categorized. Automatically collected · unverified.
Excerpt from the author’s documentation
Extracted from a fixed version of SKILL.md in its original language. This is the author’s documentation; installation, compatibility and runtime results have not been verified by this site.
Read the original English text
Topics in the source
- Senior Quality Manager Responsible Person (QMR)
- Table of Contents
- QMR Responsibilities
- ISO 13485 Clause 5.5.2 Requirements
- QMR Accountability Matrix
- Authority Boundaries
- Management Review Workflow
- Workflow: Prepare and Execute Management Review
Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements. -- QMR Responsibilities Management Review Workflow Quality KPI Management Workflow Quality Objectives Workflow Quality Culture Assessment Workflow Regulatory Compliance Oversight Decision Frameworks Tools and References -- | Responsibility | Scope | Evidence | |----------------|-------|----------| | QMS effectiveness | Monitor system performance and suitability | Management review records | | Reporting to management | Communicate QMS performance to top management | Quality reports, dashboards | | Quality awareness | Promote regulatory and quality requirements | Training records, communications | | Liaison with external parties | Interface with regulators, Notified Bodies | Meeting records, correspondence | | Domain | Accountable For | Reports To | Frequency | |--------|-----------------|------------|-----------| | Quality Policy | Policy adequacy and communication | CEO/Board | Annual review | | Quality Objectives | Objective achievement and relevance | Executive Team | Quarterly | | QMS Performance | System effectiveness metrics | Management | M
This is an excerpt. Refer to the complete source and its current requirements.
- Source repository
- alirezarezvani/claude-skills
- Source file
- ra-qm-team/skills/quality-manager-qmr/SKILL.md
- Fixed revision
- 8f082544116fc0d014188e521ca40304cdfc86b0
Sources and evidence
This record was collected automatically. Its documentation, suitability and runtime behavior have not been manually verified.
Author: alirezarezvani/claude-skills · original repository metadata. Documentation review: Not reviewed. Last source check: 2026-11-09T14:01:47.511Z.
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License and attribution
MIT. Third-party content and copyright remain with their authors. Refer to the original license and terms.
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