Document Control Procedure Sample
Here's a sample Document Control Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how documents are managed and controlled within the organization to ensure accuracy, consistency, and compliance with ISO 9001 requirements.
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Document Control Procedure
Purpose:
This Document Control Procedure is established to ensure that all organizational documents, including policies, procedures, work instructions, and records, are controlled, maintained, and updated to support the effective operation of the Quality Management System (QMS) in accordance with ISO 9001:2015 requirements.
Scope:
This procedure applies to all documents and records generated and used within the organization.
Responsibilities:
1. Document Owner: The author or creator of a document is responsible for its content and accuracy. The document owner is also responsible for initiating updates when necessary.
2. Document Controller: The Document Controller is responsible for overseeing the document control process, including document distribution, retrieval, and archiving.
2. Document Controller: The Document Controller is responsible for overseeing the document control process, including document distribution, retrieval, and archiving.
Procedure:
1. Document Creation:
a. The Document Owner creates a new document or revises an existing one as necessary to meet organizational needs or ISO 9001 requirements.
b. The Document Owner ensures that the document is clear, accurate, and includes the appropriate format and content.
2. Document Review:
a. The Document Owner submits the document to the Document Controller for review and approval.
b. The Document Controller reviews the document for conformity with established document control procedures, format, and content.
c. If revisions are required, the Document Owner is notified and requested to make the necessary changes.
d. Once the document is deemed satisfactory, the Document Controller approves it for distribution.
3. Document Distribution:
a. The Document Controller is responsible for distributing approved documents to relevant personnel.
b. Documents may be distributed in both hard copy and electronic formats, depending on the nature of the document and the preferences of recipients.
4. Document Retrieval:
a. All employees are responsible for using the most current version of documents when performing their work.
b. Outdated documents are to be immediately returned to the Document Controller for disposal.
5. Document Updates:
a. The Document Owner is responsible for identifying the need for document revisions, which may arise due to changes in regulations, processes, or identified improvements.
b. The Document Owner initiates the update process by making the necessary changes to the document.
c. The revised document is submitted to the Document Controller for review and approval, following the same process as outlined in Section 2.
6. Document Archiving:
a. Obsolete documents are archived by the Document Controller to maintain historical records.
b. Archived documents are retained for the period specified in the organization's document retention policy and in accordance with legal requirements.
Record Keeping:
The Document Controller maintains a record of all documents, their revisions, and distribution history. Records include the document's title, version, date of approval, and distribution list.
Review and Audit:
This Document Control Procedure shall be reviewed and audited periodically to ensure its effectiveness and compliance with ISO 9001:2015 requirements.
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Please note that this is a sample document control procedure, and you should tailor it to your organization's specific needs, structure, and processes. Additionally, consult with legal and regulatory requirements that may apply to document retention in your industry.
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