quality-manager-qms-iso13485

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:

• GitHub
• Your agentic skill in the SkillzWave marketplace

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-materials/.

Why it matters: You're promising implementation details and templates that developers can't actually access. This breaks the Progressive Disclosure structure completely - you're supposed to layer your content from quick-start to expert, but instead you're pointing to dead links. Plus, without actual templates, the utility drops because people can't immediately apply your guidance.

The fix: Either create those referenced files with real content (iso13485-procedures.md with actual procedures, audit-checklists with concrete checklists) OR make SKILL.md self-contained. Cut the references to nonexistent files and inline the essential guidance directly. This alone would bump you +15 points.

Other Things Worth Fixing

1. Dump the marketing language - "Expert-level", "Senior Quality Manager", "comprehensive", "seamless integration" - these add fluff. Just say what the skill does: "Implement ISO 13485 Quality Management Systems for medical device organizations"

2. Pick one term per concept - You're mixing QMS with "Quality Management System", KQI with "quality metrics", "process audit" with "internal audit". Pick one and stick with it throughout.

3. Add a table of contents - At 187 lines without a TOC, developers waste time scrolling. Add a simple Contents section after the frontmatter listing your main sections.

4. Trim the ASCII art - That document lifecycle tree (lines 38-60) looks nice but burns tokens unnecessarily. Convert it to a numbered list: "1. Creation and Approval 2. Distribution and Access" etc.

Quick Wins

• Remove all nonexistent file references (+15 points) - This is your biggest bang for buck
• Cut marketing adjectives and flatten voice (+2 points) - Takes 10 minutes
• Add TOC + standardize terminology (+4 points) - Improves usability significantly
• Inline or delete the ASCII art (+1 point) - Token efficiency win

These four items alone could get you to 72/100 with focused edits.

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