quality-manager-qmr

---
name: quality-manager-qmr
description: Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance per ISO 13485 Clause 5.5.2.
category: Regulatory & Quality
version: 1.0.0
tools: []
---

# Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2.

## 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

Conduct management reviews per ISO 13485 Clause 5.6, minimum annually (typically quarterly or semi-annually), notifying required attendees at least 2 weeks prior: CEO/General Manager (strategic decisions), QMR (chair — overall QMS status), Department Heads (process performance), RA Manager (regulatory changes), Production Manager (product conformity), Customer Quality (complaint data).

Collect inputs from process owners and compile with trend analysis: audit results (completed vs. planned, findings by severity, trends); customer feedback (complaints received and rate, Satisfaction Score, returns and %, top issues); process performance and product conformity (first pass yield, nonconformance rate, scrap cost, top defect categories); CAPA status (open, overdue, effectiveness rate, average age); previous action items (completed/in progress/overdue); QMS changes (regulatory, organizational); recommendations. Distribute the agenda and package 1 week prior. Validate that every input was reviewed and decisions were documented with owners and due dates.

**Outputs to document**: QMS improvement decisions (action items with due dates and owners), resource needs, quality objectives changes, and process improvement needs (charters owned by process owners).

## Quality KPI Management

### Establish Quality KPI Framework

1. Identify quality objectives requiring measurement.
2. Select KPIs per objective using SMART criteria: Specific (clear definition and calculation), Measurable (quantifiable with available data), Actionable (team can influence results), Relevant (aligned to quality objectives), Time-bound (defined measurement frequency).
3. Define target values from baseline data and benchmarks.
4. Assign a data source and collection owner.
5. Set reporting frequency per KPI category.
6. Configure dashboards and trend analysis.
7. Define escalation thresholds and alert triggers.
8. Validate each KPI has an owner, target, data source, and escalation criteria.

### Core Quality KPIs

| Category | KPI | Target | Calculation |
|----------|-----|--------|-------------|
| Process | First Pass Yield | >95% | (Units passed first time / Total units) × 100 |
| Process | Nonconformance Rate | <1% | (NC count / Total units) × 100 |
| CAPA | CAPA Closure Rate | >90% | (On-time closures / Due closures) × 100 |
| CAPA | CAPA Effectiveness | >85% | (Effective CAPAs / Verified CAPAs) × 100 |
| Audit | Finding Closure Rate | >90% | (On-time closures / Due closures) × 100 |
| Audit | Repeat Finding Rate | <10% | (Repeat findings / Total findings) × 100 |
| Customer | Complaint Rate | <0.1% | (Complaints / Units sold) × 100 |
| Customer | Satisfaction Score | >4.0/5.0 | Average of survey scores |

### KPI Review Frequency

| KPI Type | Review Frequency | Trend Period | Audience |
|----------|------------------|--------------|----------|
| Safety/Compliance | Daily monitoring | Weekly | Operations |
| Production Quality | Weekly | Monthly | Department heads |
| Customer Quality | Monthly | Quarterly | Executive team |
| Strategic Quality | Quarterly | Annual | Board/C-suite |

### Performance Response Matrix

| Performance Level | Status | Action Required |
|-------------------|--------|-----------------|
| >110% of target | Exceeding | Consider raising target |
| 100-110% of target | Meeting | Maintain current approach |
| 90-100% of target | Approaching | Monitor closely |
| 80-90% of target | Below | Improvement plan required |
| <80% of target | Critical | Immediate intervention |

## Quality Objectives

Set and maintain measurable objectives per ISO 13485 Clause 5.4.1: review prior-year achievement, analyze performance trends and gaps, align to strategy, draft measurable objectives, validate resource availability, obtain executive approval, and communicate organization-wide. Each objective must be measurable, with an owner, target, and timeline.

**Objective structure**: objective statement, aligned policy element, target, baseline, owner, due date, success criteria, Measurement Method (how progress is tracked), reporting frequency, supporting initiatives, resource requirements.

| Category | Example Objectives | Typical Targets |
|----------|-------------------|-----------------|
| Customer Quality | Reduce complaint rate | <0.1% of units sold |
| Process Quality | Improve first pass yield | >96% |
| Compliance | Maintain certification | Zero major NCs |
| Efficiency | Reduce quality costs | <4% of revenue |
| Culture | Increase training completion | >98% on-time |

Review quarterly: progress vs. target (adjust resources if behind), relevance (modify if conditions changed), resources (request more if insufficient), barriers (escalate obstacles).

## Quality Culture Assessment

Annually: select or design a survey instrument, define the population, communicate purpose and confidentiality, run a 2-week response window, analyze by department/role/tenure, identify strengths and gaps, and build an action plan. Validate response rate >60% and that the plan addresses the bottom 3 scores.

| Dimension | Indicators | Assessment Method |
|-----------|------------|--------------------|
| Leadership commitment | Visible management support for quality | Survey, observation |
| Quality ownership | Employees feel responsible for quality | Survey |
| Communication | Quality information flows effectively | Survey, audit |
| Continuous improvement | Suggestions submitted and implemented | Metrics |
| Training and competence | Employees feel adequately trained | Survey, records |
| Problem solving | Issues addressed at root cause | CAPA analysis |

Map gaps to actions: low leadership visibility → gemba walks, all-hands updates; inadequate training → competency-based programs; poor communication → newsletters, huddles; low reporting → anonymous reporting, no-blame culture; lack of recognition → quality award programs.

## Regulatory Compliance Oversight

### Multi-Jurisdictional Compliance Matrix

| Jurisdiction | Regulation | Requirement | Status Tracking |
|--------------|------------|-------------|-----------------|
| EU | MDR 2017/745 | CE marking, Notified Body | Technical file, annual review |
| USA | 21 CFR 820 (QMSR) | FDA registration, QMSR compliance — 21 CFR 820 incorporates ISO 13485:2016 by reference (effective 2026-02-02; formerly the QSR) | Annual registration, inspections |
| International | ISO 13485 | QMS certification | Surveillance audits |
| Germany | MPG/MPDG | National implementation | Competent authority filings |

Maintain a regulatory requirement register, track update services, assess change impact monthly, update affected processes within 90 days of the effective date, verify training completion, document status at management review, and maintain an inspection readiness checklist covering personnel availability, document accessibility, prior finding status, and facility walk-through readiness. Validate that all applicable requirements are mapped and no registrations are expired.

> **Decision discipline**: this matrix is decision support, not a compliance determination. Final regulatory-status calls are yours to make as QMR and must be signed off by the named owner; route FDA-specific questions to Regulatory Affairs and verify current 21 CFR 820 (QMSR) / ISO 13485:2016 text at fda.gov before relying on any citation here.

**Regulatory authority interface**: Notified Body audit (QMR is primary contact — prepare audit package, personnel schedules); FDA inspection (QMR hosts/coordinates escort — inspection readiness review); Competent Authority inquiry (QMR coordinates response — technical file access); regulatory meetings (QMR attends or delegates — briefing materials).