ISO 9001: Document Control and Record Keeping Requirements

ISO 9001 requires organizations to have documented procedures for both document control and record keeping. These procedures should define how documents are created, approved, and distributed. They should also define how records are created, stored, and maintained.

Document control and record keeping are essential for the effective implementation of ISO 9001. By following the requirements of the standard, organizations can ensure that they have the necessary documentation and records in place to support their quality management system.

Here are some additional details on the document control and record keeping requirements of ISO 9001:

Document control: Organizations must have a documented procedure for controlling all documents that are used to support the quality management system.
This procedure should include the following:

• A list of all controlled documents
• A process for approving and issuing documents
• A process for updating and controlling changes to documents
• A process for ensuring that obsolete documents are removed from use

Record keeping: Organizations must have a documented procedure for identifying, storing, and maintaining all records that are required to be maintained under the quality management system.
This procedure should include the following:

• A list of all required records
• A process for identifying and collecting records
• A process for storing and protecting records
• A process for ensuring that records are accessible when needed
• A process for disposing of records when they are no longer needed