nicu-picu/SOPs/SOP-001-Document-Control.md

Standard Operating Procedure: Document Control

Document ID	SOP-001
Title	Document Control
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	Quality Assurance

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1. Purpose

To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.

2. Scope

This procedure applies to all controlled documents including:

• Policies
• Standard Operating Procedures (SOPs)
• Work Instructions
• Forms and Templates
• Clinical Protocols
• Emergency Procedures
• External documents of external origin

3. Responsibilities

3.1 Document Owner

• Responsible for document content and accuracy
• Initiates document creation and revision
• Ensures periodic review is performed

3.2 Quality Assurance

• Maintains the document control system
• Assigns document numbers
• Manages document distribution
• Archives obsolete documents

3.3 Approvers

• Review and approve documents before release
• Ensure documents are adequate for intended purpose

4. Procedure

4.1 Document Creation

1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Submit for review and approval

4.2 Document Review and Approval

1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Final approval by designated approver
5. Quality Assurance releases document

4.3 Document Numbering

Documents shall be numbered according to the following convention:

Type	Prefix	Example
Policy	POL	POL-001
General SOP	SOP	SOP-001
Ventilator SOP	SOP-VENT	SOP-VENT-001
Sedation SOP	SOP-SED	SOP-SED-001
Nutrition SOP	SOP-NUT	SOP-NUT-001
Transport SOP	SOP-TRN	SOP-TRN-001
Emergency SOP	SOP-EMR	SOP-EMR-001
Infection Control SOP	SOP-INF	SOP-INF-001
Work Instruction	WI	WI-001
Form	FRM	FRM-001

4.4 Revision Control

1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer

4.5 Document Distribution

1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed

4.6 Periodic Review

1. Clinical protocols reviewed at least annually
2. Standard SOPs reviewed at least every 2 years
3. Review documented even if no changes made
4. Reviews may result in revision or reaffirmation

5. Related Documents

• FRM-001 Document Change Request Form
• FRM-002 Document Review Record

6. Definitions

Term	Definition
Controlled Document	Document managed under document control system
Obsolete	Document no longer valid for use
Revision	Updated version of a document

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]