11 Procedures for Validation of Diagnostic

Actually, each clinical and/or biochemical laboratory has responsibility for demonstrating its competence and therefore must obtain results of good quality. Medical laboratories provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. As result, the accreditation of clinical laboratories is shifting from being a “recommendation” to becoming a “requirement” in many countries throughout Europe and in the other countries around the world (Berwouts, 2010). Accreditation is defined by ISO as the “Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks”. Although accreditation also considers the quality management system (QMS), it has additional formal requirements of technical competence, including initial and continuous training of personnel, validation of methods and instruments, and internal and external quality control. A good QMS in the laboratory has a lot of advantages such as increased transparency, traceability, uniformity, work satisfaction and better focus on critical points. On the contrary, it will require extra time on aspects such as document control and there is a danger of losing critical attitude and curbing innovation and changes. Therefore, a formal accreditation and the linked periodical audits are stimulant for keeping the quality system (QS) alive. Without accreditation, there is a danger of giving less attention to quality improvement. In addition, accreditation is a good way to demonstrate and attest competence and a worldwide tool to recognize laboratories. Finally, all parties (patients, families, the laboratory and clinicians) are benefited through better processes and quality of results (Berwouts, 2010). All essential elements of QS are covered by the ISO 15189 accreditation standard in two distinct chapters: management requirements and technical requirements. Technical elements