Quality Manager Qms Iso13485
This handles ISO 13485 quality management system workflows for medical device companies. You'd reach for it when dealing with document control, CAPA processes, supplier management, or audit preparation in a regulated environment. It's built around the specific requirements of medical device QMS rather than generic quality management, which matters if you're actually trying to maintain compliance. The structure suggests it can walk through risk management documentation and design control procedures, though without seeing the implementation details it's hard to say how opinionated it is about your existing processes. Useful if you're tired of reinventing QMS prompts every time you need to draft a deviation report or update an SOP.
- skills.sh installs
- 795
- GitHub stars
- 29.5K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 --agent claude-codeInstalls into .claude/skills of the current project.
Files
Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.
Table of Contents
- QMS Implementation Workflow
- Document Control Workflow
- Internal Audit Workflow
- Process Validation Workflow
- Supplier Qualification Workflow
- QMS Process Reference
- Decision Frameworks
- Tools and References
QMS Implementation Workflow
Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.
Workflow: Initial QMS Implementation
Sponsors
Agent CaffeineSponsoredClose your lid, come back to finished work
SnugSponsoredThe clipboard manager for the AI eraPromote your product hereReach 125k+ visitors monthly
WaxSponsoredBlock anything with supervision, without erasing your iPhonePromote your product hereReach 125k+ visitors monthly
knobsSponsoredSee your site on any phone, any day, in any languageDetails
- Repository
- github.com/alirezarezvani/claude-skills
- Categories
- Documentation, Code Review & Quality, Design & UI/UX
- First seen
- Jun 3, 2026
More from alirezarezvani/claude-skills
All 267- Sales Engineer788
- Fda Consultant Specialist782
- Landing Page Generator777
- Contract And Proposal Writer772
- Sql Database Assistant763
- Chief Of Staff760
- Copywriting759
- Qms Audit Expert758
- Marketing Ops756
- Quality Manager Qmr755
- Performance Profiler750
- Mdr 745 Specialist745
- Demo Video736
- Ad Creative733
- Revenue Operations733
- Gcp Cloud Architect732
- Analytics Tracking731
- Competitive Intel729
- Customer Success Manager729
- Product Discovery729
- Epic Design728
- Codebase Onboarding727
- Cmo Advisor726
- Content Production726
Recommended
More Documentation
remotion-video-toolkitshreefentsar/remotion-video-toolkitComplete toolkit for programmatic video creation with Remotion + React. Covers animations, timing, rendering (CLI/Node.js/Lambda/Cloud Run), captions, 3D, chart793skills.sh installs
nielsen-heuristics-auditmastepanoski/claude-skillsEvaluate UX/UI using Jakob Nielsen's 10 usability heuristics. Comprehensive audit of visibility, control, consistency, error prevention, recognition, flexibilit791skills.sh installs
react-refactorpproenca/dot-skillsArchitectural refactoring guide for React applications covering component architecture, state architecture, hook patterns, component decomposition, coupling and791skills.sh installs
vitesthairyf/skillsVitest fast unit testing framework powered by Vite with Jest-compatible API. Use when writing tests, mocking, configuring coverage, or working with test filteri789skills.sh installs
startup-pitchferdinandobons/startup-skillBuild investor-ready pitch scripts in multiple formats (10-min, 5-min, 2-min, 1-min elevator, investor email). Produces pitch narratives, Q&A preparation, pitch788skills.sh installs
order-lifecyclejoellewis/finance_skillsGuide the design and implementation of order lifecycle management in trading systems. Owns FIX application-layer message flows (NewOrderSingle, ExecutionReport,780skills.sh installs