OpenClaw

quality-manager-qmr

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.

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安装与使用

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技能说明

Senior Quality Manager Responsible Person (QMR)

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

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

来源信息

Source: github
Repository: openclaw/skills
Path: skills/alirezarezvani/quality-manager-qmr
Version: —
Commit: 5758133d08f0a1c8135ba601dfabcfe4a2926f19
分类来源: rules
状态: active
可见性: public

这些信息来自收录时的来源分析，可能滞后；使用前请核对最新来源文件。

来源内容

SKILL.md

# 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 |
|---------...

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