Documented information refers to information that the organization is required to control and maintain, together with the medium on which it is contained. It brings the “document” and “record” concepts of the older standards together under a single term.
Two forms of use
- Maintained information: Defines how work is to be done. Procedures, instructions, policies, process sheets.
- Retained information: Evidence of what was done. Records, reports, measurement results, audit findings.
Is a quality manual mandatory?
No. Current management system standards do not mandate a specific set of documents. The organization decides for itself which information needs to be documented for the effective operation of its processes.
However, some clauses explicitly require documented information; these are stated in the text of the standard.
Control expectations
Information is expected to be available, legible, appropriately identified, current and authorized; changes must be controlled, and the retention period and disposal method must be defined.
For information kept in digital media, access rights, backup and version control are also within this scope. The virtual location concept of ISO 19011:2026 requires these environments to be included in the audit programme.
Documentation control is a common clause of all management systems sharing the harmonized structure; in integrated systems it can be managed under a single umbrella. The standard-specific counterpart of the expectations is addressed in programmes such as the ISO 9001 training. Contact us for integrated system trainings.