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Chapter 22 : International Organization for Standardization
This chapter provides an overview of the International Organization for Standardization (ISO). Operating since 1947, the International Organization for Standardization (ISO) is a nongovernmental association consisting of representatives from over 150 countries, one member per country. The increased credibility associated with ISO certification leads to many advantages that include decreased operating expenses stemming from scrap and rework, and enhanced management control through management review participation. The chapter describes the ISO standards most relevant in a clinical laboratory service setting. The quality standards in the ISO 9000 family focus on quality management and include quality-management system (QMS) requirements that are general for the manufacturing and service industries. The ISO 9001 standard requires extensive interpretation, while ISO 15189 is an international standard specifically developed for medical laboratories, although it may be of relevance to such disciplines as clinical physiology and medical imaging. The chapter describes the process for obtaining and maintaining ISO certification. ISO certification can be an attractive credential for a clinical laboratory. The College of American Pathologists (CAP) continues to play a role in the development of the ISO 15189 standard and, since 2008, has been a certifying body for this standard. The certification process is followed by ongoing maintenance of the QMS by the laboratory, as well as surveillance audits performed by the certifying body.