EN ISO 15189:2022/A11:2023 PDF
Medical laboratories - Requirements for quality and competence
Medical laboratories - Requirements for quality and competence
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 15 ноября 2023 г.
- Издание:
- CEN EN 15189 edition 1 version 1
- ICS:
- 03.120.10
No scope available
Abstract
Overview
EN ISO 15189:2022/A11:2023 is a critical European amendment to the international standard ISO 15189, specifically tailored for medical laboratories. Published by the European Committee for Standardization (CEN) in November 2023, this standard defines the in medical laboratories, ensuring reliable and accurate laboratory testing critical to patient care. It serves as a foundational framework facilitating laboratory accreditation, aligning with EU regulations such as Regulation (EC) No 765/2008 on accreditation and market surveillance.
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