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ISO 15189 recognizes that medical


laboratories are enterprises with a technical function. Quality management must address both typical management concerns and special technical aspects. ISO 15189 does so by drawing ISO/ IEC 17025. ISO 15189 is a generic document that has clear functional application to all divisions of a medical laboratory, regardless of the services it provides or the way it is organized: the standard is as relevant in a full-service medical laboratory as it is in a laboratory providing services exclusively for clinical pathology or surgical pathology. A well-developed quality management system also clarifies that the quality of the laboratory’s operations is intimately tied to the efforts of its quality partners:  The public, through the media, opinion, and political voices, demands that medical laboratories provide quality performance


“Medical laboratories often serve a diversity of clients”


 Clinicians who expect accurate, effective, and efficient services and partnership


 Equipment and reagent suppliers and services providers who provide goods and services that are consistent in performance


 External quality assessors who provide challenges that are realistic and educational


 Standards development organizations on the basis of local, regional, and national policies and processes


 Reference laboratories that provide consistent, reliable service. A quality management system in


compliance with ISO 15189 requires recognition of the importance and impact that these partnerships have on the quality of the laboratory’s output.


CONCLUSION Finally, the sophisticated public of today, with awareness enhanced by the internet, is more familiar with how institutions conduct and sustain their business practices. The question is; could medical laboratories in the Middle East adopt this harmonized approach and deploy it in its business model? Which lab in the Middle East would strive to obtain this recognition and be listed among the only six listed labs in USA accredited by CAP/ISO 15189? ■


ML


 REFERENCES References available on request (magazine@informa.com)


38 www.lifesciencesmagazines.com


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