n Medical Technology SA - The global need for quality : peer reviewed review

Volume 27, Issue 2
  • ISSN : 1011-5528


The literature on quality management is explored to gain insight into the role of quality management in assuring quality products and services. The notion of quality is first described as point of departure for the exploration of systems to produce quality. In considering various approaches to quality management systems, international approaches are explored and some fundamental underlying principles of quality and the application of these principles in the context of medical laboratories are addressed. Standards contain technical specifications or precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose. When applied in organisations, they contribute to increasing the reliability and effectiveness of the goods and services delivered. An international standard may be used as such, or may be implemented through incorporation into the national standards of individual counties. Quality management systems in relation to certification and accreditation, and the particular standards applicable to medical laboratories are described in this overview on the global need for quality.

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