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New Quality Management Document


Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute announces the publication of External Assessments, Audits, and Inspections of the Laboratory (QMS17).

QMS17 is intended for use by individuals responsible for the laboratory’s external assessment activities, including laboratory management, quality coordinators, compliance officers, clinical research coordinators, and administrative and technical personnel. This guideline may be applied to laboratories of any size and functional complexity, including but not limited to:

  • Medical laboratories
  • Public health laboratories
  • Research laboratories
  • Cell therapy and tissue processing laboratories
  • Veterinary laboratories
  • Food laboratories
  • Environmental laboratories

External Assessments, Audits, and Inspections of the Laboratory (QMS17) (https://clsi.org/media/1799/qms17ed1_sample.pdf) provides recommendations for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external organization. This includes selecting and evaluating an external assessment organization, preparing for and undergoing a successful assessment, and sustaining ongoing readiness for assessment.

“Looking at external assessment or accreditation as a process to be fully supported and sustained, rather than as discrete events involving anxiety and often frenzied activity is key to a measured and efficient approach to readiness. The concepts in this guideline, provided by laboratory, industry, and external assessment organization experts, are fundamental to selecting and effectively managing external assessments,” said Joan M. Carlson, MLT(CMLTA), BSc(MLS), MT(ASCP), Chairholder of QMS17 and Provincial Quality Lead, Laboratory Services, Alberta Health Services.

Features of this document include guidance for:

  • Seeking an assessment for the first time
  • Considering whether to use a new external assessment organization
  • Improving laboratory processes to achieve and sustain positive assessment outcomes

For more information about QMS17, contact 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 nearly 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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