ISO/IEC 17025:2005 实验资格及校准实验室认证的一般要求

标准编号：ISO/IEC 17025:2005

中文名称：实验资格及校准实验室认证的一般要求

英文名称：General requirements for the competence of testing and calibration laboratories

发布日期：2005-05

标准范围

ISO/IEC 17025:2005规定了进行试验和/或校准（包括取样）能力的一般要求。它包括使用标准方法、非标准方法和实验室开发的方法进行的测试和校准。它适用于所有执行测试和/或校准的组织。例如，这些实验室包括第一、第二和第三方实验室，以及测试和/或校准构成检验和产品认证一部分的实验室。ISO/IEC 17025:2005适用于所有实验室，不考虑人员数量或测试和/或校准活动范围。当实验室不进行ISO/IEC 17025:2005所涵盖的一项或多项活动时，如取样和新方法的设计/开发，这些条款的要求不适用。ISO/IEC 17025:2005供实验室在开发质量、行政和技术操作管理体系时使用。实验室客户、监管机构和认证机构也可以使用它来确认或认可实验室的能力。ISO/IEC 17025:2005不打算用作实验室认证的基础。ISO/IEC 17025:2005未涵盖实验室运行的监管和安全要求。

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.

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