Which components of document management are required to comply with ISO standards?

The requirement for document management to comply with ISO standards focuses heavily on the control of documents and the control of records. This is pivotal for ensuring that all relevant documents are accurate, accessible, and properly managed throughout their lifecycle.

Control of documents involves creating, reviewing, approving, and distributing documents relevant to the quality management system. This process ensures that only current, approved versions of documents are in circulation, which is crucial for maintaining compliance and consistency.

Control of records, on the other hand, ensures that evidence of conformity to requirements and the effective operation of the quality management system is properly maintained and retrievable. This encompasses everything from proper storage to the retention and disposal of records as per regulatory requirements.

Both elements are essential for establishing a robust document management system that adheres to ISO standards, as they collectively ensure that the necessary documentation and records are properly handled to meet compliance expectations. Such controls prevent the risk of using outdated or incorrect information, thereby enhancing quality assurance within the organization.