Document Control Procedure Template

Document Number: SOP-4.2.4-001 Title: Control of Documents Revision: 00 Effective Date: [DATE] Page: 1 of [X]

DOCUMENT CONTROL

Approval Signatures

Role	Name	Date
Author	[NAME]	[DATE]
Reviewer	[NAME]	[DATE]
Approver (Quality Manager)	[NAME]	[DATE]

Revision History

Revision	Date	Description of Changes	Approved By
00	[DATE]	Initial release	[NAME]

Purpose
Scope
Definitions
Responsibilities
Procedure
- 5.1 Document Types and Hierarchy
- 5.2 Document Numbering System
- 5.3 Document Creation
- 5.4 Document Review and Approval
- 5.5 Document Distribution and Access
- 5.6 Document Changes
- 5.7 Control of Obsolete Documents
- 5.8 Control of External Documents
Records
References
Attachments

1. PURPOSE

This procedure establishes requirements for the control of documents within the Quality Management System to ensure:

Documents are approved before use
Documents are reviewed, updated, and re-approved as necessary
Changes and current revision status are identified
Relevant versions of documents are available at points of use
Documents remain legible and readily identifiable
External documents are identified and controlled
Obsolete documents are prevented from unintended use
Obsolete documents are appropriately identified if retained

This procedure ensures compliance with ISO 13485:2016 Clause 4.2.4.

2. SCOPE

This procedure applies to all controlled documents within the Quality Management System, including but not limited to:

Quality Manual
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Forms and templates
Medical Device Files
Design and Development documents
Risk management documents
Validation and verification protocols and reports
Specifications (product, process, test methods, materials)
Drawings and schematics
Labels and instructions for use
External documents (standards, regulations, customer specifications)

This procedure does NOT apply to:

Records (controlled per SOP-[NUMBER] Control of Records)
Transient documents (emails, meeting notes not part of QMS)
Marketing and sales materials (unless affecting product quality or regulatory compliance)

3. DEFINITIONS

Term	Definition
Controlled Document	A document that is subject to review, approval, distribution control, and change management per this procedure
Master Document	The official controlled copy maintained by Document Control, from which all distributed copies originate
Document Owner	The person or department responsible for the content, accuracy, and maintenance of a document
Document Control Coordinator	Person responsible for managing the document control system
Revision	A change to a controlled document that has been approved and issued
Obsolete Document	A document that has been superseded by a newer revision or is no longer applicable
External Document	A document originating from outside the organization (standards, regulations, customer specifications, etc.)
SUPERSEDED	Watermark applied to obsolete documents retained for reference

4. RESPONSIBILITIES

4.1 Document Control Coordinator

Manages document control system
Assigns document numbers
Maintains master document repository
Ensures proper document approval before release
Distributes controlled documents
Maintains distribution lists
Retrieves and destroys/archives obsolete documents
Maintains document control records
Trains personnel on document control procedures

4.2 Document Owners

Create and maintain documents within their area
Ensure document accuracy and completeness
Initiate document changes when needed
Participate in document review and approval
Identify when documents become obsolete
Ensure personnel in their area use current documents

4.3 Quality Manager

Approves all QMS documents (SOPs, Quality Manual)
Reviews document changes for QMS impact
Ensures document control system effectiveness
Audits document control compliance

4.4 Department Managers

Approve department-specific work instructions
Ensure current documents available in their areas
Ensure personnel trained on document changes
Remove obsolete documents from use areas

4.5 All Personnel

Use only current, approved documents
Report document issues (errors, illegibility, missing documents)
Do not use obsolete or unapproved documents
Maintain documents in good condition

5. PROCEDURE

5.1 Document Types and Hierarchy

QMS documents are organized in a four-tier hierarchy:

Tier 1: Quality Manual (QM)

Policy-level document
Describes overall QMS
References all Tier 2 procedures
Approved by CEO and Quality Manager

Tier 2: Standard Operating Procedures (SOPs)

Define WHAT must be done, WHO does it, WHEN
Cross-functional processes
Include all 31 required documented procedures per ISO 13485
Approved by Quality Manager

Tier 3: Work Instructions (WIs)

Define HOW to perform specific tasks
Step-by-step instructions
Department or process-specific
Approved by Department Manager and Quality Manager

Tier 4: Forms and Templates

Standardized formats for data collection
Support SOPs and WIs
Approved by Document Owner and Quality Manager

Other Controlled Documents:

Medical Device Files (MDFs)
Design History Files (DHFs)
Validation documents
Specifications
Drawings
Labels and instructions for use

5.2 Document Numbering System

All controlled documents are assigned unique identification numbers:

Quality Manual:

Format: QM-[###]
Example: QM-001

Standard Operating Procedures:

Format: SOP-[ISO Clause]-[###]
Example: SOP-4.2.4-001 (for Clause 4.2.4 Control of Documents)
Example: SOP-8.5-001 (for CAPA procedure)

Work Instructions:

Format: WI-[Department Code]-[###]
Example: WI-MFG-001 (Manufacturing department work instruction)
Department codes: MFG (Manufacturing), QC (Quality Control), ENG (Engineering), etc.

Forms:

Format: FORM-[SOP/WI Number]-[Letter]
Example: FORM-SOP-8.5-001-A (CAPA Request Form)

Medical Device Files:

Format: MDF-[Product Code]-[###]
Example: MDF-ABC-001

Other Documents:

Format varies by document type
Assigned by Document Control Coordinator

Revision Designation:

Initial release: Revision 00
First revision: Revision 01
Subsequent revisions: 02, 03, 04, etc.
Format: [Document Number] Rev [##]

5.3 Document Creation

5.3.1 Initiating Document Creation

Document Owner identifies need for new document
Document Owner notifies Document Control Coordinator
Document Control Coordinator:
- Assigns document number
- Provides document template (if applicable)
- Logs document in master list as "In Development"

5.3.2 Document Format Requirements

All controlled documents must include:

Header (on each page):

Document number
Document title
Revision number
Effective date
Page number (Page X of Y)

Document Control Section:

Approval signature table
Revision history table

Content Requirements:

Clear, concise language
Present tense, active voice
Consistent terminology
Numbered sections and subsections
References to related documents
Records generated (if applicable)

5.3.3 Document Drafting

Document Owner drafts document content
Document Owner marks document as "DRAFT" on each page
Draft may be circulated for informal review and input
When ready for formal review, Document Owner submits to Document Control Coordinator

5.4 Document Review and Approval

5.4.1 Review Process

Document Control Coordinator:
- Verifies document number correct
- Verifies format compliance
- Checks for required sections
- Routes for review
Reviews conducted by:
- Technical reviewer (subject matter expert)
- Quality reviewer (for QMS compliance)
- Other stakeholders as appropriate
Reviewers:
- Review for technical accuracy
- Review for clarity and completeness
- Review for compliance with requirements
- Provide comments to Document Owner
Document Owner:
- Addresses all comments
- Revises document as needed
- Resubmits for approval

5.4.2 Approval Process

Approval authority based on document type:

Document Type	Approval Authority
Quality Manual	CEO and Quality Manager
Standard Operating Procedures	Quality Manager
Work Instructions	Department Manager and Quality Manager
Forms	Document Owner and Quality Manager
Specifications	Engineering Manager and Quality Manager
Medical Device Files	[Per regulatory requirements]

Approval Steps:

Document Control Coordinator routes document to approvers
Approvers review and sign/date approval section
All required approvals must be obtained before document becomes effective
Document Control Coordinator:
- Removes "DRAFT" watermark
- Adds effective date (typically [X] days after approval)
- Assigns final format
- Adds to controlled document system
- Updates master document list

5.4.3 Training Requirements

Before document becomes effective:

Affected personnel identified
Training conducted as needed
Training records maintained per SOP-[NUMBER]

5.5 Document Distribution and Access

5.5.1 Master Document

Document Control Coordinator maintains master copy
Master stored in: [ELECTRONIC SYSTEM or PHYSICAL LOCATION]
Master clearly identified as "MASTER COPY"
Master is reference for all distributed copies

5.5.2 Controlled Copies

Electronic Distribution (Primary Method):

Documents stored in [DOCUMENT MANAGEMENT SYSTEM]
Access controlled by user permissions
Read-only access for most users
Always displays current revision
Obsolete revisions automatically removed from access
Users may print for immediate use (uncontrolled copies)

Physical Distribution (When Necessary):

Controlled copies issued for specific locations/uses
Each copy stamped "CONTROLLED COPY - [Copy Number]"
Distribution list maintained showing:
- Copy number
- Document number and revision
- Holder name and location
- Date issued
Holders responsible for maintaining copy in good condition
When document revised, Document Control retrieves old copy and issues new copy

5.5.3 Uncontrolled Copies

Printed for temporary, immediate use
Stamped or marked "UNCONTROLLED COPY"
User responsible for verifying current revision before each use
Should be destroyed after use or within [X] days

5.5.4 Availability at Point of Use

Current documents available where work is performed
Electronic access at workstations
Controlled physical copies in areas without electronic access
Documents protected from damage, loss, deterioration

5.6 Document Changes

5.6.1 Initiating Changes

Changes may be initiated by:

Document Owner identifying need
CAPA requiring procedure change
Internal audit finding
Management review action
Regulatory or standard update
Process improvement

5.6.2 Change Request Process

Requestor:
- Completes Document Change Request Form (Attachment A)
- Describes change needed and justification
- Submits to Document Owner
Document Owner:
- Reviews change request
- Determines if change appropriate
- Approves or denies request
- If approved, initiates document revision

5.6.3 Making Changes

Document Owner:
- Requests current master from Document Control
- Creates revised version with changes
- Increments revision number
- Updates revision history table
- Identifies changes in document (change bars, highlights, or summary)
- Marks as "DRAFT REVISION"
Changes reviewed and approved by:
- Same approval authority as original document
- UNLESS different approval authority designated by original approver
- Reviewers have access to previous revision for comparison
Approval:
- New revision approved per Section 5.4.2
- Previous revision becomes obsolete on effective date of new revision

5.6.4 Indication of Changes

Changes are indicated by:

Revision history table (describes nature of changes)
Change bars or highlights in document (optional but recommended)
Change summary page for significant revisions (optional)

5.6.5 Urgent Changes

For urgent changes affecting safety or regulatory compliance:

Expedited review and approval process
May use interim method (e.g., hand-written changes with approval)
Formal document revision completed as soon as practical
Document per CAPA process if change due to nonconformity

5.7 Control of Obsolete Documents

5.7.1 When Document Becomes Obsolete

Document becomes obsolete when:

New revision approved and becomes effective
Document no longer applicable to operations
Product discontinued
Process changed

5.7.2 Removal from Use

Document Control Coordinator:
- On effective date of new revision, marks superseded revision as obsolete
- Removes from electronic document system OR limits access with "OBSOLETE" notation
- Retrieves physical controlled copies from distribution locations
- Updates distribution lists
Department Managers:
- Remove obsolete copies from work areas
- Return to Document Control or destroy
- Ensure personnel aware of new revision

5.7.3 Retention of Obsolete Documents

Obsolete documents may be retained for:

Reference purposes
Product investigations
Regulatory or legal requirements
Historical record

If retained:

Clearly marked "OBSOLETE - FOR REFERENCE ONLY" or "SUPERSEDED"
Stored separately from current documents
Access restricted and controlled
Retained per applicable retention requirements

Retention Locations:

Electronic archive with "OBSOLETE" watermark
Separate physical archive area

5.7.4 Prevention of Unintended Use

To prevent unintended use:

Physical copies stamped "OBSOLETE" in red
Electronic copies watermarked "OBSOLETE"
Removed from active work areas
Stored in separate archive
Training on document control system and how to verify current revision

5.8 Control of External Documents

5.8.1 Types of External Documents

External documents include:

ISO standards
IEC standards
FDA regulations and guidance documents
EU regulations (MDR, IVDR)
Other regulatory requirements
Customer specifications
Supplier certifications
Calibration certificates
Reference materials

5.8.2 Identification and Control

Document Owner or requestor:
- Identifies external document needed
- Provides copy to Document Control Coordinator
Document Control Coordinator:
- Assigns external document number: EXT-[Category]-[###]
- Logs in external document register including:
  - Document title and number
  - Source/publisher
  - Date/version
  - Location in organization
  - Responsible person for monitoring updates
- Files in external document repository

5.8.3 Reviewing for Currency

Document Owner responsible for monitoring updates to external documents
Frequency: [Annually or as notified of updates]
Check publisher website for updates
Subscribe to update notifications when available
When update identified:
- Obtain new version
- Provide to Document Control
- Review for impact on QMS documents
- Update QMS documents as needed (per CAPA if necessary)
- Obsolete previous version per Section 5.7

5.8.4 Customer-Supplied Documents

Customer specifications and drawings controlled as external documents
Review for clarity and completeness upon receipt
Discrepancies communicated to customer for resolution
Controlled per this procedure to ensure current version used

6. RECORDS

Records generated and maintained per this procedure:

Record	Retention Period	Location	Responsible Party
Master Document List	Current + [X] years	[LOCATION/SYSTEM]	Document Control Coordinator
Document Approval Records	[X years or device lifetime]	Document Control System	Document Control Coordinator
Document Revision History	[X years or device lifetime]	Document Control System	Document Control Coordinator
Document Change Requests	[X years]	[LOCATION]	Document Control Coordinator
Distribution Lists	Current + [X] years	[LOCATION]	Document Control Coordinator
Obsolete Document Archive	[Per retention schedule]	[LOCATION]	Document Control Coordinator
External Document Register	Current + [X] years	[LOCATION]	Document Control Coordinator

7. REFERENCES

ISO 13485:2016, Clause 4.2.4 - Control of Documents
Quality Manual, Section 4.2.4
SOP-4.2.5 - Control of Records
SOP-6.2 - Training and Competence

8. ATTACHMENTS

Attachment A: Document Change Request Form Attachment B: Document Templates (QM, SOP, WI, Form) Attachment C: Document Control Flowchart Attachment D: Master Document List Template Attachment E: Distribution List Template

END OF PROCEDURE

Document Number: SOP-4.2.4-001 Revision: 00 Page: [X] of [X]

Document Control Procedure Template

Document Control Procedure Template