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. 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.
Profile →npx skills add alirezarezvani/claude-skills --skill quality-manager-qmr --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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 regulato
- Table of Contents
- QMR Responsibilities
- ISO 13485 Clause 5.5.2 Requirements
- QMR Accountability Matrix
- Authority Boundaries
- Management Review Workflow
- Workflow: Prepare and Execute Management Review
- Required Attendees
- Management Review Input Template
- Management Review Output Requirements
- Quality KPI Management Workflow
- Workflow: Establish Quality KPI Framework
- Core Quality KPIs
- KPI Review Frequency
What does the quality-manager-qmr skill do?
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.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill quality-manager-qmr --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.