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DS/ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories
This document specifies a process for a medical laboratory to identify and manage the risks to*patients, laboratory workers and service providers that are associated with medical laboratory*examinations. The process includes identifying, estimating, evaluating, controlling and*monitoring the risks.*The requirements of this document are applicable to all aspects of the examinations and services*of a medical laboratory, including the pre-examination and post-examination aspects,*examinations, accurate transmission of test results into the electronic medical record and other*technical and management processes described in ISO15189.*This document does not specify acceptable levels of risk.*This document does not apply to risks from post-examination clinical decisions made by*healthcare providers.*This document does not apply to the management of risks affecting the medical laboratory*enterprise that are addressed by ISO 31000, such as business, economic, legal, and regulatory*risks.*NOTE – International, national, or regional regulations or requirements may also apply to specific*topics covered in this international standard
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Danish Standards [ds]
