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Manage Nonconforming Events in the Lab With a Quality Management System


Nonconforming events in the laboratory can be reduced by implementing an effective quality management system (QMS). A laboratory QMS is a systematic, integrated set of activities to establish and control the work processes from preanalytical through postanalytical processes, manage resources, conduct evaluations, and make continual improvements to ensure consistent quality results.1 All aspects of the laboratory operation need to be included in a QMS.

Quality system essentials QSEs are the foundational building blocks that support the laboratory’s workflow. One QSE is Nonconforming Event Management.

A nonconforming laboratory event management program is based on principles of quality management, risk management, and patient safety. The program should be structured, organized, and used consistently throughout the laboratory to:

  • Report a nonconformance.
  • Investigate the cause of the nonconformance.
  • Determine if any action is needed and, if so, perform necessary action.
  • Track and trend all nonconformances.
  • Identify opportunities to improve the efficiency and effectiveness of work processes.
  • Identify opportunities to reduce or eliminate risks and improve patient safety.

Representatives from all laboratory departments should be involved in development of the NCE program. The representatives should promote the program and act as role models in implementation and follow-up activities. Management should demonstrate support and commitment for the program.

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.


  1. Carey RB, et al. 2018. Implementing a quality management system in the medical microbiology laboratory. Clin Microbiol Rev 31:e00062-17. https://doi.org/10.1128/CMR .00062-17.


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