Control of Records SOP template (ISO 15189:2022)

A records control procedure describes how the laboratory preserves evidence of what happened, who performed the work and which decisions were made. Unlike instructions that can be revised for future use, records need to remain trustworthy accounts of completed activities. The procedure applies to paper logs, electronic entries, instrument files and other retained evidence within the laboratory's defined scope.

A good version explains how records are identified, completed, corrected, stored and retrieved. It assigns responsibility for access permissions and protection against loss, unauthorised changes or disclosure. A retention schedule should distinguish record categories and state the basis for local retention periods, taking account of applicable legal, clinical and contractual obligations rather than using one unexplained period for everything.

Practical arrangements matter as much as policy statements. Describe secure archiving, backup responsibilities, retrieval checks and authorised disposal, including records held by external providers. Explain how corrections preserve the original information and identify the person making the change. Connect electronic record controls with information management procedures so that staff know how to proceed during downtime, system replacement or migration without losing traceability or exposing patient information.