Shorts on Standards: ISO 22367: Application of risk management to medical laboratories

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ISO 22367 presents the following structured approach to risk management in the context of a quality management system:

• Definition of risk as both the frequency with which a hazard occurs as well as the severity of harm that may result when a hazard occurs.
• Acceptability and/or control of risks, initially and when problems occur.
• Recognition that controlling an identified risk may cause or worsen other associated risks (unintended consequences).
• Evaluation of residual risk.
• Balance of perceived benefit against residual risk that still presents significant hazard.

As a tool for understanding one’s processes and addressing problems beyond immediate corrective action, risk management is an effective approach to assessing hazards and associated potential harm in a complex environment. ISO 22367 guides the application of risk management specific to the clinical laboratory with the intent of identifying, evaluating, and controlling such risks.

Dr. Castellani, formerly of Penn State Hershey College of Medicine, is a member of the CAP Standards Committee. He is the CAP liaison to the ISO workgroup responsible for the ISO 22367 document and a member of its drafting committee.