Quality Manager Qms Iso13485
If you're building or maintaining medical device QMS systems, this handles the full ISO 13485 implementation cycle from gap analysis through certification audits. It includes actual audit checklists for process, system, and product audits, plus automation scripts for performance dashboards and management review prep. The templates cover everything from design control stages to supplier qualification criteria. What stands out is the depth on document control lifecycle management and the quarterly management review structure, both of which are tedious to set up from scratch. Most useful when you need someone who knows clause references cold and can map process documentation to specific regulatory requirements.
- skills.sh installs
- 306
- GitHub stars
- 33.2K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add davila7/claude-code-templates --skill quality-manager-qms-iso13485 --agent claude-codeInstalls into .claude/skills of the current project.
Files
Senior Quality Manager - QMS ISO 13485 Specialist
Expert-level ISO 13485 Quality Management System implementation and maintenance for medical device organizations with deep knowledge of quality processes, documentation control, and continuous improvement.
Core QMS Competencies
1. ISO 13485 QMS Implementation
Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements.
Implementation Workflow:
-
Gap Analysis and Planning
- Current state assessment against ISO 13485 requirements
- Gap identification and prioritization
- Implementation roadmap development
- Resource allocation and timeline planning
-
QMS Design and Documentation
- Quality Manual development per ISO 13485 clause 4.2.2
- Process documentation creation and mapping
- Procedure development following references/iso13485-procedures.md
- Work instruction standardization
-
Process Implementation
- Cross-functional training and competency development
- Process deployment and monitoring
- Performance metrics establishment
- Feedback loop integration
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- Repository
- github.com/davila7/claude-code-templates
- Categories
- Git & Pull Requests, Documentation, Code Review & Quality, Design & UI/UX
- First seen
- Jun 3, 2026
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