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This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring. This document is applicable to a)    the confidentiality of personal information, for the requestor and the service laboratory, b)    the laboratory safety…

This document specifies general requirements for proficiency tests that are offered to in vivo bioassay measurement facilities operating a whole-body counter (WBC) or partial body counter (PBC) for monitoring of persons. It specifies minimum requirements for proficiency testing applicable to dosimetry laboratories that have dedicated facilities for in vivo monitoring and where accreditation is…

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also…

This document provides detailed descriptions of statistical methods for proficiency testing providers to use to design proficiency testing schemes and to analyse the data obtained from those schemes. This document provides recommendations on the interpretation of proficiency testing data by participants in such proficiency testing schemes and by accreditation bodies. The procedures in this…

This document specifies a method for determining optical and dielectric constants in the UV-VIS-NIR spectral range as well as layer thicknesses in the field of at-line production control, quality assurance and material development through accredited test laboratories. It is applicable to stand-alone measuring systems. The presentation of the uncertainty of results conforms to ISO/IEC Guide 98-3.

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal,…

1 Scope 1.1 General This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions. It does not provide specific details on how to achieve these requirements since they are provided in many other sources which are…

ISO 4094:2017 provides both general requirements and specific requirements (Annex A) for laboratories seeking to become "Authorized Laboratories (ALs)" and to maintain their Authorized Laboratory status for the issue of optical reference transfer standards of level 3. This document follows the requirements and adopts the format of ISO/IEC 17025, with the aims of: a) establishing and…

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…

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…