Nonconforming Work and Corrective Action SOP template (ISO 15189:2022)

A nonconforming work and corrective action procedure explains what the laboratory does when an activity or result does not meet its requirements. It links immediate control of the problem with evaluation of its significance and prevention of recurrence. The document should cover issues detected before reporting as well as problems discovered after results have reached clinical users.

A good version makes reporting accessible and identifies who can stop work, withhold results, arrange urgent communication or authorise resumption. It distinguishes correction of the immediate problem from corrective action directed at its cause. Evaluation should consider the extent of the issue, possible patient harm, related work and whether previously reported results need review or amendment.

Investigation instructions should encourage evidence gathering rather than assumptions about individual error. Describe how causes are assessed, actions selected and responsibilities agreed. Not every minor isolated issue needs an extensive investigation, but the reason for the chosen response should be clear. Include checks that actions were implemented and that they addressed the cause without creating new problems. Records should preserve the sequence from detection through containment, decisions, communication and closure, allowing recurring issues to be recognised during wider quality review.