scope:

This guideline is intended to assist laboratories in meeting customer-based requirements for their QMS as represented by quality system essential (QSE) Customer Focus. This guideline does not review the theory of good customer relations or service but instead discusses areas in which the laboratory should focus in order to provide appropriate outputs (such as examination results and reports), products (such as blood and tissue), and customer services (such as courier retrieval of collected specimens from physicians' offices).

This guideline is applicable to medical laboratories of any size, complexity, or specialty, including point-of-care testing. However, because the concepts of customer service and satisfaction are generic, this guideline can be used by other types of laboratories, such as public health, research, food, environmental, and veterinary laboratories. It can be used by all levels of personnel to develop and support a customer-focused laboratory.

This guideline does not apply to patients who use test devices and kits at home, because they are customers of the test kit manufacturer and not the laboratory.