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印度的临床实验室认证

Clinical laboratory accreditation in India.

作者信息

Handoo Anil, Sood Swaroop Krishan

机构信息

Quality Management Department, BLK Super Speciality Hospital, Pusa Road, New Delhi, India.

出版信息

Clin Lab Med. 2012 Jun;32(2):281-92. doi: 10.1016/j.cll.2012.04.009.

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.

摘要

临床实验室的检测结果必须确保准确,因为这些结果在医疗保健的多个领域都至关重要。实验室有必要实施质量保证以实现这一目标。质量的实施应由独立机构进行审核,这些机构被称为认可机构。认可是由权威机构进行的第三方认证,证明申请实验室符合认可机构的质量要求,并已证明其有能力开展特定任务。尽管在大多数国家,认可是强制性的,但在印度是自愿的。质量要求在许多认可组织制定的标准中有所描述。临床实验室国际认可的标准是ISO15189,它基于ISO/IEC标准17025。印度的认可机构是国家测试和校准实验室认可委员会,该委员会已与亚太实验室认可合作组织这一区域合作机构以及国际实验室认可合作组织这一顶级合作机构签署了相互认可协议。

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