developmental-pediatrics/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

---

1. Purpose

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

2. Scope

This procedure applies to all controlled documents including:

• Policies
• Standard Operating Procedures (SOPs)
• Work Instructions
• Assessment protocols
• Forms and Templates
• Clinical protocols
• 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
• Maintains clinical accuracy of assessment protocols

3.2 Quality Assurance

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

3.3 Approvers

• Review and approve documents before release
• Ensure documents are adequate for intended purpose
• Verify clinical protocols align with professional standards

3.4 Clinical Director

• Reviews and approves clinical assessment protocols
• Ensures alignment with evidence-based practice
• Verifies standardized assessment procedures

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. Reference applicable professional standards (AAP, DSM-5-TR, IDEA, etc.)
6. 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. Clinical protocols reviewed by Clinical Director
5. Final approval by designated approver
6. Quality Assurance releases document

4.3 Document Numbering

Documents shall be numbered according to the following convention:

Type	Prefix	Example
Policy	POL	POL-001
Diagnostic Evaluation SOP	SOP-DE	SOP-DE-001
Screening SOP	SOP-SCR	SOP-SCR-001
School Liaison SOP	SOP-SCH	SOP-SCH-001
Clinical SOP	SOP-CLI	SOP-CLI-001
Administrative SOP	SOP-ADM	SOP-ADM-001
Safety SOP	SOP-SAF	SOP-SAF-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
5. Clinical protocol changes reviewed for impact on assessment standardization

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. Clinical staff notified of assessment protocol updates

4.6 Periodic Review

1. Documents reviewed at least every 2 years
2. Clinical protocols reviewed annually to ensure alignment with current professional standards
3. Review documented even if no changes made
4. Reviews may result in revision or reaffirmation

4.7 External Documents

1. External standards (DSM-5-TR, ADOS-2 manual, AAP guidelines) maintained as reference
2. Latest versions obtained and archived
3. Changes to external standards trigger review of related internal documents

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
Clinical Protocol	Procedure for standardized assessment administration or clinical decision-making

---

Revision History

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