Clinical and Laboratory Standards Institute guideline QMS18—Process Management describes five published regulatory and accreditation requirements for management of laboratory processes. This guideline provides guidance, with explanations and examples, for meeting the five process management requirements as they apply to preexamination, examination, and postexamination processes. Because several other CLSI guidelines contain process management information for both laboratory examination and quality management processes, the examples in this guideline are for preexamination and postexamination processes.

This guideline replaces the first edition of the approved guideline, QMS18-Ed1, published in 2015. Several changes were made in this edition including: 

• Adding the concept of assessing every new and changed process for risks to quality and patient safety and incorporating risk controls to detect and mitigate risks that cannot be eliminated 

• Revising the process flow chart to include an activity box for risk assessment 

• Adding appropriate wording about risk assessment in every text section where it is needed

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