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Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown.

biochemia medica

The importance of having a fl exible scope ISO 15189 accreditation and quality specifi cations based on biological variation – the case of validation of the biochemistry analyzer Dimension Vista