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Procedure Control SOP

This Standard Operating Procedure (SOP-001) outlines the method for controlling documents within the Quality Management System (QMS), ensuring they are reviewed, approved, and revised systematically. It defines controlled and uncontrolled documents and assigns responsibilities to QA, Department Heads, and users. The procedure includes steps for document creation, review, distribution, revision, and handling obsolete documents.

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71 views1 page

Procedure Control SOP

This Standard Operating Procedure (SOP-001) outlines the method for controlling documents within the Quality Management System (QMS), ensuring they are reviewed, approved, and revised systematically. It defines controlled and uncontrolled documents and assigns responsibilities to QA, Department Heads, and users. The procedure includes steps for document creation, review, distribution, revision, and handling obsolete documents.

Uploaded by

hairulanuarsuli
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Standard Operating Procedure

Title: Document and Procedure Control


Document ID: SOP-001
Revision: A
Effective Date: ________________
Prepared by: QA Manager

1. Purpose
To establish a standardized method for controlling procedures, ensuring documents are
reviewed, approved, distributed, and revised in a controlled manner.

2. Scope
This SOP applies to all controlled documents within the QMS, including SOPs, WIs, Forms,
and Manuals.

3. Definitions
Controlled Document: Any QMS document subject to version control and approval.
Uncontrolled Document: Reference copy not subject to official revision control.

4. Responsibilities
- QA: Document approval, master list maintenance
- Department Heads: Review and update documents
- Users: Follow the latest approved version

5. Procedure
5.1 Document Creation
5.2 Document Review & Approval
5.3 Distribution & Access Control
5.4 Document Revision
5.5 Obsolete Document Handling

6. Records
Document Master List, Approval Log, Change History

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