ISO 9001 Control of Documents

The Control of Documents procedure is a key component of the ISO 9001 quality management system (QMS). It outlines the processes and responsibilities for creating, reviewing, approving, distributing, and maintaining documents related to the QMS.

The following are the typical steps involved in the Control of Documents procedure:

  • Document creation: Documents related to the QMS should be created by authorized personnel, such as the quality manager or process owners. The documents should be clear, concise, and accurate.
  • Document review: Before the document is approved, it should be reviewed by relevant personnel to ensure its accuracy and suitability.
  • Document approval: Once the document is reviewed and any necessary changes are made, it should be approved by authorized personnel, such as the quality manager or process owners.
  • Document distribution: The approved document should be distributed to relevant personnel, either in hard copy or electronic format. Distribution should be controlled to ensure that the latest version of the document is being used.
  • Document maintenance: The document should be regularly reviewed and updated as necessary. A document control log should be maintained to track changes and ensure that the latest version is being used.
  • Document control: Access to documents related to the QMS should be controlled to prevent unauthorized access, loss, or damage. Documents should be stored in a secure location, and only authorized personnel should have access to them.

By implementing a Control of Documents procedure, an organization can ensure that its QMS documentation is accurate, up-to-date, and readily available to authorized personnel. This can help to improve the efficiency of the QMS and ensure that the organization meets the requirements of ISO 9001.

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