Quality Manager Qmr
Provides quality system governance and management review leadership for HealthTech and MedTech companies, with oversight of regulatory compliance, quality KPIs, and QMR responsibilities per ISO 13485 Clause 5.5.2. Use when conducting management reviews, setting quality policy and objectives, monitoring quality performance metrics, or exercising quality system accountability and regulatory oversight.
- skills.sh installs
- 755
- GitHub stars
- 29.5K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add alirezarezvani/claude-skills --skill quality-manager-qmr --agent claude-codeInstalls into .claude/skills of the current project.
Files
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
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- Repository
- github.com/alirezarezvani/claude-skills
- Categories
- DevOps & CI/CD, Git & Pull Requests, Code Review & Quality, Debugging
- First seen
- Jun 3, 2026
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