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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.
Installation
Follow the repository instructions for this skill and your agent. Review the files and dependencies before adding it to your workflow.
SkillHub CLI
skillhub install alirezarezvani/quality-manager-qmrInspect the source and compatibility requirements, then follow its installation steps.
Give your agent the source link and ask it to inspect instructions and dependencies before explaining the installation steps.
Skill instructions
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
- 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
| Decision Type | QMR Authority | Escalation Required | |---------...
Source information
- Source
- github
- Repository
- openclaw/skills
- Path
- skills/alirezarezvani/quality-manager-qmr
- Version
- —
- Commit
- 5758133d08f0a1c8135ba601dfabcfe4a2926f19
- Classification source
- rules
- Status
- active
- Visibility
- public
These signals come from indexed source analysis and may lag behind changes. Check the current source files.
Extracted content
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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