Monday 7 February 2011

Medical Laboratories: ISO 9001 or ISO 15189?


ISO 9001:2008 certification involves Quality System Management whereas accreditation to the ISO 15189:2007 standard recognizes the technical competence of medical laboratories, thus providing a ready means for customers to find reliable testing services. Accreditation focuses on creating laboratory competency.

Laboratories can be checked and certified for their conformance to international management system standards such as ISO 9001:2008. This involves the assessment of an organization’s quality management system. Although this will provide confidence about the laboratory’s quality management system, it will not indicate anything about a laboratory’s technical competence or its ability to provide reliable and accurate test data that will be accepted by customers and trading partners.

Therefore laboratory accreditation to ISO 15189:2007, which is based on ISO/IEC 17025, is a measure of both technical competence and quality management and is the most appropriate process for laboratories use, rather than the quality ISO 9001:2000 certification.


Source: www.cap.org

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