Quality Manager QmrSAFE

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The instruction file, verbatim from the audited commit — this is the text the model reads, and the surface the audit's instruction layer examines. Quoted here so you can judge it without cloning anything.

---
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.
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.

---

## 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)

---

## 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 |

---

## 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 trend analysis
5. Prepare presentation materials with supporting data
6. Distribute agenda and input package 1 week prior
7. Conduct review meeting per agenda
8. **Validation:** All required inputs reviewed; decisions documented with owners and due dates

### Required Attendees

| Role | Requirement | Input Responsibility |
|------|-------------|---------------------|
| CEO/General Manager | Required | Strategic decisions |
| QMR | Chair | Overall QMS status |
| Department Heads | Required | Process performance |
| RA Manager | Required | Regulatory changes |
| Production Manager | Required | Product conformity |
| Customer Quality | Required | Complaint data |

### Management Review Input Template

```
MANAGEMENT REVIEW INPUT SUMMARY

Review Period: [Start Date] to [End Date]
Review Date: [Scheduled Date]
Prepared By: [QMR Name]

1. AUDIT RESULTS
   Internal audits completed: [X] of [X] planned
   External audits completed: [X]
   Total findings: [X] major / [X] minor
   Open findings: [X]
   Finding trends: [Analysis]

2. CUSTOMER FEEDBACK
   Complaints received: [X]
   Complaint rate: [X per 1000 units]
   Customer satisfaction score: [X.X/5.0]
   Returns: [X] units ([X]%)
   Top issues: [Categories]

3. PROCESS PERFORMANCE
   [Process 1]: [Metric] vs [Target] - [Status]
   [Process 2]: [Metric] vs [Target] - [Status]
   Out-of-spec processes: [List]

4. PRODUCT CONFORMITY
   First pass yield: [X]%
   Nonconformance rate: [X]%
   Scrap cost: $[X]
   Top defect categories: [List]

5. CAPA STATUS
   Open CAPAs: [X]
   Overdue: [X]
   Effectiveness rate: [X]%
   Average age: [X] days

6. PREVIOUS ACTIONS
   Total from last review: [X]
   Completed: [X] | In progress: [X] | Overdue: [X]

7. CHANGES AFFECTING QMS
   Regulatory: [List changes]
   Organizational: [List changes]
   Process: [List changes]

8. RECOMMENDATIONS
   [Collected improvement opportunities]
```

### Management Review Output Requirements

| Output | Documentation | Owner |
|--------|---------------|-------|
| QMS improvement decisions | Action items with due dates | Assigned per item |
| Resource needs | Resource plan updates | Department heads |
| Quality objectives changes | Updated obje

SAFEgrade B · trust 89/100 Nothing in the source contradicts what it says it does. Grade A is reserved for packages that have also passed the behavioural sandbox.

What the source does

Filesystem

none-observed

Network

none-observed

Shell

none-observed

Dependencies

pinned

Secrets in source

none-found

Findings (1)

<key>k5Ey9KFlkqpj+SDkUw+5ED9lTA3En/qUi0zdrydUCH3kMWTE3Eh65NXnFCaxlY2omY2JHnlEoK7Li7oOEvM7eG5VPdcO/sFlMfoCRdnLYdepJ+uLzYwOWR8W4yQVve/clxVFTVRL4DFleKInGdpAxIbHZT2yi4ADAMENls1N1XSLojRuqXePXDeAT/4Mv4TTx0s

Gates applied: no_behavioural_pass.