Quality Documentation Manager

If you're building or maintaining a medical device QMS, this gives you the document control scaffolding you need for ISO 13485 and 21 CFR Part 11 compliance. It covers document numbering conventions (like SOP-02-001-A), approval workflows with required reviewers by document type, change control classifications, and electronic signature requirements. The templates and procedures handle everything from draft creation through obsolescence tracking. It's comprehensive but dense, so expect to adapt the workflows to your actual DMS and approval chains rather than implementing it verbatim.

skills.sh installs: 136
GitHub stars: 1.1K
last updated: Aug 21, 2026

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Install

$ npx -y skills add borghei/claude-skills --skill quality-documentation-manager --agent claude-code

Installs into .claude/skills of the current project.

Files

Quality Documentation Manager

Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance.

Document Control Workflow
Document Numbering System
Approval and Review Process
Change Control Process
21 CFR Part 11 Compliance
Reference Documentation
Tools

Clarify First

Before setting up document control or validating a document, settle the inputs below. When one is missing or vague and would change the result, ask about it; when it wouldn't, use a sensible default and say which one you used.

SKILL.md on GitHub

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