SOP FOR DOCUMENT CONTROL & ISSUANCE

SOP Number: DOC/QA/001

Effective Date: [Effective Date]

Review Date: [Review Date]

1. PURPOSE

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for the
control and issuance of documents within the organization to ensure that all documents are
managed, maintained, and distributed effectively while maintaining version control and compliance
with regulatory requirements.

2. SCOPE

This SOP applies to all types of documents, including Standard Operating Procedures (SOPs),
protocols, manuals, forms, and any other controlled documents used within the organization.

3. RESPONSIBILITIES

Document Control Manager: Responsible for overseeing document control processes, maintaining
document databases, and ensuring compliance with document control procedures.

Department Heads: Responsible for initiating document creation or revision requests and ensuring
that documents under their supervision are reviewed, approved, and maintained.

Quality Assurance: Responsible for reviewing and approving documents, ensuring compliance with
regulatory requirements, and conducting periodic document audits.

4. PROCEDURE

4.1. Document Creation or Revision

4.1.1. Any department or individual requiring the creation or revision of a document shall submit a
Document Request Form to the Document Control Manager.

4.1.2. The Document Control Manager shall review the request, assign a unique document number,
and initiate the document creation or revision process.
4.2. Document Preparation

4.2.1. The author responsible for creating or revising the document shall prepare the content
according to the organization's template.

4.2.2. The document shall include a version number and effective date.

4.3. Document Review and Approval

4.3.1. The document shall be subject to a review and approval process involving relevant
stakeholders.

4.3.2. The author shall submit the document to the Document Control Manager, who will distribute
it for review.

4.3.3. Reviewers shall provide feedback within the specified timeframe.

4.3.4. The Document Control Manager shall compile feedback, and the author shall make necessary
revisions.

4.3.5. The final document shall be reviewed and approved by the designated approver(s).

4.4. Document Issuance

4.4.1. Once approved, the Document Control Manager shall publish the document.

4.4.2. The document shall be distributed to relevant personnel through the organization's document
management system.

4.5. Document Control and Versioning

4.5.1. The Document Control Manager shall maintain a master list of controlled documents,
including document numbers, titles, versions, and locations.

4.5.2. Changes to documents shall trigger version updates.

4.5.3. Obsolete documents shall be archived.

5. REFERENCES

[List any relevant organizational or regulatory references.]

6. ATTACHMENTS

Document Request Form

Document Review Form

7. REVISION HISTORY

Version Description Effective Date Review Date

1.0 Initial SOP [Effective Date] [Review Date]

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