scope:

This guideline is intended for use by individuals in a laboratory to facilitate establishment and maintenance of an internal nonconforming event (NCE) management program that includes:

• Responding to an event that does not conform to the laboratory's established policies, processes, and/or procedures
• Responding to an event that does not follow established QMS policies, processes, and/or procedures
• Monitoring events through the data assessment, management review, and continual improvement (CI) connected processes

This guideline is intended to supplement, but not replace, an organization's established risk management or patient safety program.

The guidance provided herein is perhaps best used within a medical laboratory; however, other types of laboratories may also find value in the concepts presented.