General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017) #
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 organisations 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.
Medical laboratories – Requirements for quality and competence (ISO 15189:2022) #
Specifies requirements for quality and competence in medical laboratories. This international standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It is also applicable for confirming or recognising the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
Medical laboratories – Requirements for safety (ISO 15190:2020) #
While this International standard is intended for use throughout the currently recognised disciplines of medical laboratory services, other services and disciplines may find it useful and appropriate. However, medical laboratories handling human pathogens requiring containment levels 3 and 4 will need to meet additional requirements to ensure safety.
Requirements for the collection and transport of samples for medical laboratory examinations (ISO 20658:2023) NEW #
This document specifies requirements and good practice recommendations for the collection and transport of samples intended for medical laboratory examinations. This document is applicable to medical laboratories and service providers, which can be independent from the medical laboratory, involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection and transport. It can also be applicable to some biobanks.
