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Validation of measurement procedures

The new ISO standard 15189 which has already been accepted by most nations will soon become the basis for accreditation in many European countries. Subclause 5.5.2 of this standard claims that the medical laboratory should only use validated procedures: "The laboratory shall use only validated procedures to confirm that the examination procedures are suitable for the intended use. Validations shall be as extensive as are necessary to meet the needs in the given application or field of application." The term validation has already been defined in ISO 9000:2000 and has been differentiated from verification: