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OVERVIEW OF ISO 15189


2003 STANDARDS AS A COMPREHENSIVE SOLUTION FOR MEDICAL LABORATORIES QUALITY MANAGEMENT PROCESSES


By Nashat Nafouri, Chairman, Healthcare Interest Group, Saudi Quality Council, KSA


BACKGROUND In the 80’s and early 90’s few medical laboratories in the Middle East applied for Collage of American Pathologists (CAP) accreditation or ISO certification in order to be recognized as internationally accredited laboratories, therefore increasing their market share.


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During that period, well-structured quality systems were primitive, if existing in the first place. In addition, the majority of practitioners were convinced that quality control was sufficient for medical laboratories business especially if combined with the CAP proficiency- testing program to ensure results


accuracy and precision. The demand on ISO 9001 certification declined dramatically in mid 90’s because of its generic language, which was difficult to apply to the medical laboratory. On the other hand, some accreditation bodies were already using ISO 17025 to accredit all types of laboratories,


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