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CLSI Publishes Revised Quality Management System Document QMS01—A Quality Management System Model for Laboratory Services


 Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute has published the fifth edition of QMS01—A Quality Management System Model for Laboratory Services .

QMS01 provides the necessary background information and infrastructure to develop a quality management system that meets the laboratory’s quality objectives and is consistent with the quality objectives of health care services. This guideline provides a structure for a comprehensive, systematic approach to building quality into the laboratory’s processes, assessing the laboratory’s performance, implementing quality improvements, and assisting in preparing for or maintaining accreditation.

The document includes useful appendixes that include:

  • Directions for performing a gap analysis.
  • An example of a quality management system implementation plan progress chart.
  • Path of workflow examples for blood transfusion, medication use, diagnostic imagine, and respiratory therapy.

Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE Co-Chairholder of QMS01 said, “QMS01 provides a simple model to understand regulatory and accreditation requirements for laboratories. This resource makes it easier to develop, manage, monitor, and improve laboratory management and technical processes in a way that accelerates quality and patient safety.”

For more information about QMS01, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.  


CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.   

For over 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.  

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.  

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