CLSI QMS19
Customer Focus in a Quality Management System
CLSI QMS19-Ed1 helps labs shift their focus towards the customer. Through this guidance, laboratories can maintain customer focus and meet the regulatory and accrediation requirements for managing external and internal customers.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2021.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline QMS19—Customer Focus in a Quality Management System defines the laboratory’s external and internal customers; outlines the fundamentals of identifying customer expectations, defining shared expectations, and communicating performance outcomes; and provides useful tools to help the laboratory focus on providing quality examination results, products, and services to its customers. The processes described in this guideline will also help laboratories meet regulatory and accreditation requirements related to managing laboratory customers.
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.
Clinical and Laboratory Standards Institute guideline QMS19—Customer Focus in a Quality Management System defines the laboratory’s external and internal customers; outlines the fundamentals of identifying customer expectations, defining shared expectations, and communicating performance outcomes; and provides useful tools to help the laboratory focus on providing quality examination results, products, and services to its customers. The processes described in this guideline will also help laboratories meet regulatory and accreditation requirements related to managing laboratory customers.
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.