Laboratory Testing and Management
Laboratory testing and management safety standards are published by ISO and IEC. The key document for any laboratory is ISO/IEC 17025, which covers the essential requirements for competence of laboratory testing. Many other packages are available for specific industries, which contain multiple standards related to medical labs,measurement management systems, and competence and proficiency.
ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
ISO 10012 and ISO/IEC 17025 Laboratories Measurement Management System Requirements Package
ISO 10012 and ISO/IEC 17025 Laboratories Measurement Management System Requirements Package
The ISO 10012 and ISO/IEC 17025 Laboratories Measurement Management System Requirements Package provides the requirements for the competence of testing and calibration laboratories using measurement management systems. The "measurement process" in this packages, addresses physical measurement activities such as design, test, production and inspection of laboratories. The ISO 10012 and ISO/IEC 17025 Laboratories Measurement Management System Requirements Package includes: ISO 10012:2003 ISO/IEC 17025:2017
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 15189:2022 ISO/IEC 17025:2017
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ISO/IEC 17043 / ISO/IEC 17025 / ISO/IEC 17000 Competence and Proficiency Testing Package
ISO/IEC 17043 / ISO/IEC 17025 / ISO/IEC 17000 Competence and Proficiency Testing Package
ISO/IEC 17043 / ISO/IEC 17025 / ISO/IEC 17000 Competence and Proficiency Testing Package provides the requirements for proficiency testing schemes and for the development and operation of proficiency testing schemes. While applicable to all types of proficiency testing schemes, the ISO/IEC 17043 / ISO/IEC 17025 / ISO/IEC 17000 Competence and Proficiency Testing Package can be used to demonstrate the competence of a proficiency testing provider's laboratory, or the laboratory subcontracted to perform test or measurements related to proficiency testing schemes. The ISO/IEC 17043 / ISO/IEC 17025 / ISO/IEC 17000 Competence and Proficiency Testing Package includes: ISO/IEC 17043:2023 ISO/IEC 17025:2017 ISO/IEC 17000:2020
