Complaints Procedure SOP template (ISO 15189:2022)

A complaints procedure gives patients, clinicians and other service users a clear route for raising concerns and receiving a considered response. It helps laboratory staff handle dissatisfaction consistently without confusing a complaint with an immediate clinical incident. A useful document covers the journey from first contact through acknowledgement, investigation, response and closure, while preserving confidentiality and access to relevant evidence.

A good version identifies who receives complaints, who evaluates their significance and who can approve the final response. It explains how to arrange an impartial review, including situations where the complaint concerns the person who would normally investigate it. Local response targets, escalation routes and communication responsibilities should be explicit rather than left to individual judgement.

The procedure should also connect complaint handling with patient safety, nonconforming work and corrective action. Describe how urgent concerns are escalated before the investigation is complete, what records demonstrate the reasoning behind a decision and how unresolved issues are handled. Reviewing recurring themes should lead to practical service improvements, not simply a count of closed cases.