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ISO/IEC 17025 and ISO 15189 Competence Testing and Calibration of Medical Laboratories Package

ISO/IEC 17025 and ISO 15189 Competence Testing and Calibration of Medical Laboratories Package

The ISO/IEC 17025 and ISO 15189 Competence Testing and Calibration of Medical Laboratories Package specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It also assists medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories. The ISO/IEC 17025 and ISO 15189 Competence Testing and Calibration of Medical Laboratories Package covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. The package includes:
ISO 15189:2012
ISO/IEC 17025:2017

ISO/IEC 17025 and ISO 15189 Competence Testing and Calibration of Medical Laboratories Package includes:

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International Organization for Standardization [ISO]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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