Sync template from atomicqms-style deployment

SOPs/SOP-001-Document-Control.md

@@ -0,0 +1,138 @@
+# 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] |