# 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 Quality Management System.

## 2. Scope

This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Specifications
- 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 |
| SOP | SOP | SOP-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. Documents reviewed at least every 2 years
2. Review documented even if no changes made
3. 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 |

---

## Revision History

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