scope:

This guideline provides a structured means for laboratory management and personnel to develop, assess, 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 workflow processes in laboratories of any size and functional complexity worldwide. This guideline can also be used for laboratories and other health care providers that perform point-of-care testing. Such laboratories include, but are not limited to, medical laboratories, public health laboratories, and physicians' offices. This guideline can also be used for developing and delivering quality management processes.

In any organization, two general types of risk are recognized:

• Enterprise risk: risk to the organization's reputation, financial stability, and continued ability to operate and stay in business.

• Process risk: risk in the organization's process activities that could compromise the quality of the process output and patient safety.

QMS18 focuses only on the second type of risk, ie, risks in laboratory processes.

This guideline 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.

The intended users of this guideline are:

• Managers, supervisors, and technical personnel who develop, perform, and oversee laboratory processes and procedures

• Pathologists, laboratory medical directors, and other medical and scientific personnel

• Regulatory and accreditation organizations

• Educators

• Manufacturers