113 lines
2.9 KiB
Markdown
113 lines
2.9 KiB
Markdown
# Standard Operating Procedure: Document Control
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| Document ID | SOP-001 |
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|-------------|---------|
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| Title | Document Control |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Assurance |
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---
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## 1. Purpose
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To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
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## 2. Scope
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This procedure applies to all controlled documents including:
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- Policies
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- Standard Operating Procedures (SOPs)
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- Work Instructions
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- Forms and Templates
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- Specifications
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- External documents of external origin
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## 3. Responsibilities
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### 3.1 Document Owner
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- Responsible for document content and accuracy
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- Initiates document creation and revision
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- Ensures periodic review is performed
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### 3.2 Quality Assurance
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- Maintains the document control system
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- Assigns document numbers
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- Manages document distribution
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- Archives obsolete documents
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### 3.3 Approvers
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- Review and approve documents before release
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- Ensure documents are adequate for intended purpose
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## 4. Procedure
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### 4.1 Document Creation
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1. Identify the need for a new document
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2. Request document number from Quality Assurance
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3. Draft document using appropriate template
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4. Include all required header information
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5. Submit for review and approval
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### 4.2 Document Review and Approval
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1. Route document to appropriate reviewers
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2. Reviewers provide comments within 5 business days
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3. Author addresses all comments
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4. Final approval by designated approver
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5. Quality Assurance releases document
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### 4.3 Document Numbering
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Documents shall be numbered according to the following convention:
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| Type | Prefix | Example |
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|------|--------|---------|
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| Policy | POL | POL-001 |
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| SOP | SOP | SOP-001 |
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| Work Instruction | WI | WI-001 |
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| Form | FRM | FRM-001 |
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### 4.4 Revision Control
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1. All changes require documented justification
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2. Changes follow same review/approval process as new documents
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3. Revision number increments with each approved change
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4. Revision history maintained in document footer
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### 4.5 Document Distribution
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1. Current versions available in document control system
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2. Obsolete versions marked and archived
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3. Training on new/revised documents as needed
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### 4.6 Periodic Review
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1. Documents reviewed at least every 2 years
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2. Review documented even if no changes made
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3. Reviews may result in revision or reaffirmation
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## 5. Related Documents
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- FRM-001 Document Change Request Form
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- FRM-002 Document Review Record
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## 6. Definitions
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| Term | Definition |
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|------|------------|
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| Controlled Document | Document managed under document control system |
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| Obsolete | Document no longer valid for use |
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| Revision | Updated version of a document |
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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