IVD industry role for quality and accreditation in medical laboratories

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory m anagement have become integral partners in building and improving the quali ty of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagn ostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, sta ndards such as ISO 9000 already exist to guide applications of quality prac tices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical labor atories will represent a great opportunity for harmonising medical laborato ries at an international level. In addition, accreditation of medical labor atories according to the proposed ISO 15189 standard can help develop the r elationships between laboratories, and the biological follow-up of travelli ng patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but als o on the basis of their own experience of ISO 9000 certification. (C) 2001 Elsevier Science B.V. All rights reserved.