Clinical and Laboratory Standards Institute document QMS11—Nonconforming Event Management provides a suggested outline and content for a program to manage a laboratory’s nonconforming events. Such a program is a fundamental component of a QMS and patient safety.

This document replaces the previous edition of the guideline, QMS11-A (GP32-A in previous coding system), published in 2007. Several changes were made in this edition, including: ? Expansion of the connected processes that define the primary activities of an NCE program ? Alignment with new or changed international, national, and accreditation requirements for laboratories since the last edition of this guideline ? Additional examples of documents and forms that can be used or modified as needed for implementing an NCE program ? Addition of an example NCE investigation ? Information related to handling externally generated communications (ie, alerts and recalls) as NCEs

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.