Manage QMS document control workflows
quality-documentation-managerskillsetup L2★17,464
alirezarezvani/claude-skills ↗What it does
Manage document numbering, approval workflows, version control per ISO 13485
Best for
Medical device manufacturers and regulated labs needing 21 CFR Part 11 compliance and change control
Inputs
- · document draft
- · document type
- · required reviewers list
Outputs
- · document number assigned
- · approval routing
- · Master List entry
Preconditions
- · Document control system active
- · reviewers and approvers identified
Failure modes
- · Duplicate document numbers
- · Broken approval chain
- · Expired documents still in use
Trust signals
- · ISO 13485 Part 1 specification
- · Doxygen-compliant header examples
- · CFR Part 11 electronic signature rules