Control of Documents SOP template (ISO 15189:2022)

A document control procedure explains how the laboratory keeps instructions, policies and other controlled information reliable at the point of use. Its purpose is to prevent staff from following obsolete or unapproved directions, whether those directions appear on a workstation, in a shared folder or beside an instrument. It should cover locally written documents and relevant external material, such as manufacturer instructions.

A good version defines ownership, technical review, approval and release as distinct activities. It describes how documents receive identifiers and revision information, how changes are communicated and how staff obtain the current authorised copy. The process should work for the laboratory's actual systems rather than assume that every document is printed or every employee has continuous electronic access.

Include arrangements for periodic review, urgent amendments, archived versions and removal of superseded copies. Explain what happens to handwritten local notes, printed bench copies and external documents when their source changes. Records should show who approved each release and when it became effective. Links to training and change management help ensure that publishing a revision is followed by a genuine change in practice.