Quality Documentation Manager

Document control system design and management for ISO 13485-compliant quality management systems.

Document Control Workflow

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
Draft	Under creation or revision — not for use
Review	Circulated for review
Approved	All signatures obtained
Effective	Training complete, released
Superseded	Replaced by newer revision
Obsolete	Archived per retention schedule

Document Types and Prefixes

Prefix	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

For numbering format, category codes, revision designation, and reviewer requirements, see references/document-control-procedures.md.

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Approval and Review Process

1. Author completes draft and submits for review
2. Reviewers provide comments within 5-10 business days
3. Author addresses comments with disposition (Accept/Reject/Defer)
4. Approvers sign and date
5. Validation: All required reviewers completed; all comments addressed

For approval matrix, signature requirements, and comment disposition details, see references/document-control-procedures.md.

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Change Control Process

1. Identify need for change and complete Change Request Form
2. Document Control assigns change number
3. Route to reviewers for impact assessment
4. Obtain approvals based on change classification
5. Author implements approved changes
6. Update revision number and change history
7. Validation: Changes match approved scope; change history complete

Change Classification

Class	Definition	Approval Level
Administrative	No content impact	Document Control
Minor	Limited content change	Process Owner + QA
Major	Significant content change	Full review cycle
Emergency	Urgent safety/compliance	Expedited + retrospective

For impact assessment checklist and change history documentation, see references/document-control-procedures.md.

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21 CFR Part 11 Compliance

Electronic record and signature controls for FDA compliance.

Key Requirements

• Validate system for accuracy and reliability
• Implement secure audit trail for all changes
• Restrict system access to authorized individuals
• Generate accurate copies in human-readable format
• Electronic signatures must be unique, at least 2 components, linked to record

For full Part 11 scope, audit trail requirements, electronic signature manifestation, and system controls checklist, see references/21cfr11-compliance-guide.md.

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Document Control Metrics

Metric	Target
Document cycle time	<30 days
Review completion rate	>95% on time
Change request backlog	<10 open
Overdue review rate	<5%
Audit finding rate	<2 per audit

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Tools and References

Tool	Purpose
document_validator.py	Validate document metadata and Part 11 controls

Document	Content
document-control-procedures.md	Numbering, lifecycle, review/approval, change control, retention
21cfr11-compliance-guide.md	Part 11 scope, electronic records/signatures, validation, gap assessment

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Regulatory Requirements

ISO 13485:2016 Clause 4.2

Sub-clause	Requirement
4.2.4	Control of documents
4.2.5	Control of records

FDA 21 CFR 820

Section	Requirement
820.40	Document controls
820.180	General record requirements
820.181	Device master record