Quality Documentation Manager

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. Validation: Document accessible at point of use; obsolete versions removed