Documents relevant to a quality management system (QMS) must be controlled. Controlled documents are approved and reviewed by authorized functions – to avoid documents being issued or changed by anyone.
Changes and current document revision status are identified to avoid unintended use of obsolete versions. Obsolete versions are removed to avoid unintended use.
Controlled documents are available at points of use and are kept legible and readily identifiable.
Documents of external origin considered relevant to the QMS must be controlled: They must be identified, and updated versions kept.