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Medical laboratories — Application of risk management to medical laboratories
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 | 11.100.01 : 약실험 일반 |
| 페이지수 | 82 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 22367:21 | Medical laboratories — Application of risk management to medical laboratories (Adopted ISO 22367:2020, first edition, 2020-02) | 2021-01-01 | 표준 |
| 2 | ISO 22367:2020 | Medical laboratories — Application of risk management to medical laboratories | 2020-02-25 | 표준 |
| 3 | ISO/TS 22367:2008 | Medical laboratories — Reduction of error through risk management and continual improvement | 2008-04-24 | 구판 |
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