Examination Procedure (Analyser SOP) SOP template (ISO 15189:2022)

An analyser examination procedure is the bench-level instruction for performing a defined examination using a specified system. It translates the laboratory's verified or validated method into a sequence that trained staff can follow consistently. It should identify the examination, intended clinical use and applicable instrument configuration without replacing access to current manufacturer instructions.

A good version starts with the method principle and specimen requirements, including preparation, stability and unsuitable samples. It then describes reagents, calibrators, controls and the practical steps from instrument readiness to result review. Calibration and quality control instructions must explain acceptance decisions and what staff do when those decisions prevent routine testing. Calculation, units, reportable limits and result flags need enough detail to avoid ambiguous reporting.

The document should also explain interferences, limitations and safety precautions relevant to the actual method. Distinguish routine operation from troubleshooting that requires additional authorisation. Reference supporting records and procedures rather than duplicating long maintenance instructions that may change separately. Before release, have an experienced operator check the sequence at the bench and confirm that the written steps match the configured analyser and local reporting workflow.