DIN EN ISO 22367:2025-05
Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22367:2025); German and English version prEN ISO 22367:2025 / Note: Date of issue 2025-04-18*Intended as replacement for DIN EN ISO 22367 (2020-09).
| Fecha edición: |
2025-05-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Checks|Definitions|Error avoidance|Laboratories|Laboratory medicine|Laboratory techniques|Laboratory testing|Laboratory tests|Management|Medical equipment|Medical laboratory equipment|Medical sciences|Medical technology|Patient protection|Public health|Quality|Quality assurance|Quality management|Risk|Risk analysis|Risk management|Surveillance (approval) |
| ICS: | 11.100.01 - Medicina de laboratorio en general |
| CTN: |
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