Risk Management SOP template (ISO 15189:2022)

A risk management procedure explains how the laboratory identifies situations that could affect patients, staff or the reliability of its services and decides what to do about them. It should support proportionate decisions throughout the examination pathway, including changes, unusual operating conditions and dependencies on other organisations. A useful process makes uncertainties visible rather than treating completion of a risk register as the final objective.

A good version defines a consistent assessment method, the people involved and the information needed to judge significance. If scoring is used, explain the categories and decision thresholds so that teams apply them consistently. Consider existing controls before selecting additional treatment, and identify who can accept remaining risk or escalate a concern beyond local authority.

The procedure should connect risk assessment with practical action planning, change control and review of incidents or performance signals. Each treatment needs an owner, a completion expectation and a way to check whether it works. Include review triggers such as service changes, equipment failures or new evidence about a hazard. Records should explain the reasoning behind decisions and show when residual risk was reviewed, rather than preserve scores without the context needed to interpret them.