External Quality Assessment Procedure SOP template (ISO 15189:2022)

An external quality assessment procedure explains how the laboratory plans participation, handles challenge material and uses provider reports to evaluate examination performance. It should make participation an active quality activity rather than an administrative exercise ending when results are submitted. Define the examinations, locations and methods covered, together with responsibility for checking whether suitable schemes are available.

A good version describes receipt, storage, examination and submission of material within the provider's instructions. It explains how routine staff and usual examination processes are involved, while respecting scheme rules and avoiding inappropriate collaboration or special treatment. Submission checks should prevent transcription errors without changing the nature of the assessment. Arrangements for examinations without suitable schemes need documented alternatives and a reasoned basis.

The procedure should then describe timely review of reports, investigation of unacceptable or concerning performance and assessment of possible effects on patient results. Include responsibility for corrective actions, follow-up evidence and review of recurring patterns. Retain enough records to connect each assessment event with the method used, results submitted, conclusions reached and actions completed. A satisfactory later report should support, not replace, evaluation of whether the identified cause was addressed.