quality-documentation-manager - Manage medical device quality documents
Manages document numbering, lifecycle control, review, approval, change control, and electronic record compliance for medical device QMS documentation.
Tags
Updated: 2026-09-30Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Assign document numbers
- Control document lifecycles
- Route document reviews
- Record approval signatures
- Manage document changes
- Assess change impacts
- Maintain change histories
- Implement audit trails
- Control electronic signatures
Inputs
- Document type
- Category code
- Controlled template
- Review assignments
- Approval requirements
- Change request
- Impact assessment
- Electronic record
Outputs
- Numbered documents
- Review workflows
- Approved documents
- Released documents
- Document Master List updates
- Change control records
- Change history entries
- Audit trail entries
- Electronic signature records
Requirements
- ISO 13485-compliant quality management system
- Document control system or DMS
- Authorized reviewers and approvers
- Authorized electronic signature users
- Validated electronic record system