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quality-manager-qms-iso13485

579 stars 112 forks
0
F

ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.

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#claude-ai#management review#claudecode-subagents#claude-ai-skills#QMS#claude-skills#Management System#claude-code

Third-Party Agent Skill: Review the code before installing. Agent skills execute in your AI assistant's environment and can access your files. Learn more about security

Installation for Agentic Skill

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skilz install alirezarezvani/claude-skills/quality-manager-qms-iso13485
skilz install alirezarezvani/claude-skills/quality-manager-qms-iso13485 --agent opencode
skilz install alirezarezvani/claude-skills/quality-manager-qms-iso13485 --agent codex
skilz install alirezarezvani/claude-skills/quality-manager-qms-iso13485 --agent gemini

First time? Install Skilz: pip install skilz

Works with 22+ AI coding assistants

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Download Agent Skill ZIP

Extract and copy to ~/.claude/skills/ then restart Claude Desktop

1. Clone the repository:
git clone https://github.com/alirezarezvani/claude-skills
2. Copy the agent skill directory:
cp -r claude-skills/ra-qm-team/quality-manager-qms-iso13485 ~/.claude/skills/
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Need detailed installation help? Check our platform-specific guides:

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Agentic Skill Details

Owner
alirezarezvani (GitHub)
Repository
claude-skills
Stars
579
Forks
112
Type
Other
Meta-Domain
Primary Domain
Market Score
0
Agentic Skill Grades →

Agent Skill Grade

F
Score: 51/100 Click to see breakdown

Score Breakdown

Spec Compliance
12/15
PDA Architecture
8/30
Ease of Use
14/25
Writing Style
5/10
Utility
9/20
Modifiers: +3

Areas to Improve

  • Missing Referenced Files
  • Marketing Language
  • Inconsistent Terminology

Recommendations

  • Focus on improving Pda (currently 8/30)
  • Focus on improving Ease Of Use (currently 14/25)
  • Focus on improving Writing Style (currently 5/10)

Graded: 2026-01-24

Developer Feedback

I found your QMS skill while reviewing ISO 13485 implementations - the scope of covering quality management across compliance, documentation, and audit trails is ambitious. At 51/100, there's solid foundation work here, but the execution has some gaps that are worth exploring.

Links:

The TL;DR

You're at 51/100, which is F territory. This evaluation is based on Anthropic's progressive disclosure architecture standards and the skill grading rubric used across the marketplace.

Strongest area: Spec Compliance (12/15) - your YAML frontmatter is solid and the naming convention is correct. Weakest area: Progressive Disclosure Architecture (8/30) - this is where most of your points are sitting on the table. The utility score (9/20) also took a hit because referenced resources don't actually exist.

What's Working Well

  • Clear trigger phrases - "ISO 13485", "QMS", "quality management", "internal auditing" - these will activate appropriately when developers need them
  • Comprehensive scope - You're covering the full lifecycle: document control, risk management, CAPA processes, internal audits. That's legitimately useful for regulated industries
  • Well-organized structure - The headers are logical and sections flow naturally; navigation feels intuitive
  • Targeted audience - The focus on medical device companies tackling certification is a real problem worth solving

The Big One: Missing Referenced Files

This is your biggest blocker. The SKILL.md references 14+ files that don't exist: iso13485-procedures.md, design-control-templates.md, supplier-qualification-criteria.md, plus entire directories like audit-checklists/, qms-templates/, and `training-mate...

AI-Detected Topics

Extracted using NLP analysis

claude-ai management review claudecode-subagents claude-ai-skills QMS claude-skills Management System claude-code ISO process

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