ISO 22367-2020 pdf free download.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 Iso 15189.
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 medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
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impact or desirable outcome of a process (3.19), procedure (3117) or the use of a medical device on the health of an individual or a positive impact on patient management or public health
Note I to entry: Benefits include prolongation of life, reduction of pain, (relief of symptoms), improvement in function, or an increased sense of well-being.
occurrence or change of a particular set of circumstances
Note 1 to entry: An event can be one or more occurrences, and can have several causes.
Note 2 to entry: An event can consist of something not happening.
Note 3 to entry: An event can sometimes be referred to as an “incident” or “accident’.
Note 4 to entry: An event without consequences can also be referred to as a “near miss”, “incident”, “near hitN or “close call”.[SOURCE: ISO Guide 73:2009,].ISO 22367 pdf download.