quality-manager-qmr

The saved excerpt is a snapshot from review. The external source remains the complete and most current version.

---
name: "quality-manager-qmr"
description: Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.
triggers:
  - management review
  - quality policy
  - quality objectives
  - QMR responsibilities
  - quality system effectiveness
  - quality KPIs
  - cost of quality
  - quality performance
  - management accountability
  - regulatory oversight
  - quality culture
  - quality governance
---

# 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 |
|---------------|---------------|---------------------|
| Process changes within QMS | Approve with owner | Major process redesign |
| Document approval | Final QA approval | Policy-level changes |
| Nonconformity disposition | Accept/reject with MRB | Product release decisions |
| Supplier quality actions | Quality holds, audits | Supplier termination |
| Audit scheduling | Adjust internal audit schedule | External audit timing |
| Training requirements | Define quality training needs | Organization-wide training budget |

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## Management Review Workflow

Conduct management reviews per ISO 13485 Clause 5.6 requirements.

### Workflow: Prepare and Execute Management Review

1. Schedule management review (minimum annually, typically quarterly or semi-annually)
2. Notify all required attendees minimum 2 weeks prior
3. Collect required inputs from process owners:
   - Audit results (internal and external)
   - Customer feedback (complaints, satisfaction, returns)
   - Process performance and product conformity
   - CAPA status and effectiveness
   - Previous review action items
   - Changes affecting QMS (regulatory, organizational)
   - Recommendations for improvement
4. Compile input summary report with tre