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.

Install to Claude Code

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