Agent skill · writing content · alirezarezvani
quality-documentation-manager
Use for QMS document control: numbering, versioning, change control or 21 CFR Part 11 e-signatures. Validates documents with document_validator.py and tracks versions with document_version_control.py.
Why this skill is useful
Provides specific workflows and compliance procedures for managing quality documentation in medical devices that the AI wouldn't reliably generate on its own.
What it needs
About 9k tokens when loaded. Last updated 2026-08-05. 23,939 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 --- 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. Validation: Document accessible at point of use; obsolete versions removed Document Lifecycle Stages Stage Definition Actions Required ------- ------------ ------------------ Draft Under creation or revision Author editing, not for use Review Circulated for review Reviewers provide feedback Approved All signatures obtained Ready for training/distribution Effective Training complete, released Available for use Superseded Replaced by newer revision Remove from active use Obsolete No longer applicable Archive per retention schedule Document Types and Prefixes Prefix Document Type Typical Content -------- --------------- ----------------- QM Quality Manual QMS overview, scope, policy SOP Standard Operating Procedure Process-level procedures WI Work Instruction Task-level step-by-step TF Template/Form Controlled forms SPEC Specification Product/process specs PLN Plan Quality/project plans Required Reviewers by Document Type Document Type Required Reviewers Required Approvers --------------- ------------------- ------------------- SOP Process Owner, QA QA Manager, Process Owner WI Area Supervisor, QA Area Manager SPEC Engineering, QA Engineering Manager, QA TF Process Owner QA Desig …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/quality-documentation-manager--d95471