controlled document

A controlled document provides approved information that is maintained through an organized lifecycle. Examples include procedures, policies, forms, and instructions used to direct laboratory work. Control typically covers identification, authorization, version status, availability, review, changes, and withdrawal of obsolete copies. A document can be electronic or paper; the medium alone does not determine whether it is controlled.

Staff must be able to identify the current authorized version where the work occurs. External documents, such as manufacturer instructions, also need appropriate control when they guide laboratory activities. Blank forms are documents; completed forms usually become records. A sensible control process makes changes traceable without creating unnecessary barriers to access, and provides a way to handle urgent revisions before outdated instructions cause harm.

Accreditation depends on reliable instructions being available to the people performing the work. Assessors may compare the approved version with copies on benches, shared drives, or instruments. Evidence should show who authorized changes and how affected staff were informed. A signature page is not enough if obsolete instructions remain in routine use.