Agent skill · writing content · borghei
quality-documentation-manager
Document control for medical device QMS, covering numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflows, and electronic signature compliance.
Why this skill is useful
Provides specific workflows and compliance requirements for managing quality documentation in medical devices that the AI wouldn't reliably generate on its own.
What it needs
About 12k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
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. --- Table of Contents 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, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Document type — QM, SOP, WI, TF, SPEC, or PLN (sets the required reviewers, approvers, and numbering) [ ] Regulatory scope — ISO 13485 only vs 21 CFR Part 11 electronic records (determines whether audit-trail and e-signature controls are required) [ ] Change classification — administrative, minor, major, or emergency (sets the approval path and impact assessment) Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the document. Document Control Workflow Implement document control from creation through obsolescence: 1. Assign document number per numbering procedure 2. Create document using controlled template 3. Route for review to required reviewers 4. Address review comments and document responses 5. Obtain required approval signatures 6. Assign effective date and distribute 7. Update Document Master List 8. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/quality-documentation-manager