Clinical laboratory accreditation in India |
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Authors: | Handoo Anil Sood Swaroop Krishan |
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Affiliation: | Quality Management Department, BLK Super Speciality Hospital, Pusa Road, New Delhi, India. |
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Abstract: | Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation. |
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Keywords: | Clinical Laboratory Accreditation Laboratory Quality Management Quality Assurance ISO 9001 Certification ISO 15189 Accreditation NABL India |
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