|Publication Date:||1 March 2015|
This guideline provides a structured means for laboratory management and staff to develop, implement, monitor, and change laboratory work processes, with suggestions for how laboratories can meet the related regulatory and accreditation requirements. This guideline can be used for managing and delivering preexamination, examination, and/or postexamination phases of workflow in laboratories of any size and functional complexity worldwide, including laboratories and other health care providers that perform point-of-care testing. Such laboratories include, but are not limited to, medical laboratories and public health laboratories. This guideline can also be used for developing and delivering quality management processes.
This document does not provide details about information covered in other CLSI documents or available in published literature. Instead, this guideline provides a high-level overview in which to apply the detailed information.
QMS18 is a guideline for how to implement requirements established in international standards, and by regulatory and accrediting organizations for managing laboratory work processes. QMS18 is not a standard; that is, this guideline does not set requirements for implementing and controlling laboratory processes and procedures. Instead, this guideline describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards2-13 for process management and control, and provides suggestions and examples for fulfilling the requirements.