quality-manager-qmr

# 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)
- [Decision Frameworks](#decision-frameworks)
- [Tools and References](#tools-and-references)

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## QMR Responsibilities

### ISO 13485 Clause 5.5.2 Requirements

| 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 |

### QMR Accountability Matrix

| 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 | Monthly |
| Regulatory Compliance | Compliance status across jurisdictions | CEO | Quarterly |
| Audit Program | Audit schedule completion, findings closure | Management | Per audit |
| CAPA Oversight | CAPA effectiveness and timeliness | Executive Team | Monthly |

### Authority Boundaries

| Decision Type | QMR Authority | Escalation Required |
|---------...