Interpretation of ISO 15189:2012“Medical laboratories-Requirements for quality and competence” -Requirements for IVD manufacturers
10.3760/cma.j.issn.1009-9158.2015.07.020
- VernacularTitle:ISO 15189：2012《医学实验室质量和能力的要求》解读－对制造商的要求
- Author:
Dongmei HU
;
Yali ZHOU
;
Peijun ZHAI
- Publication Type:Journal Article
- Keywords:
Laboratory,hospital;
Quality control;
Diagnostic equipment
- From:
Chinese Journal of Laboratory Medicine
2015;(7):502-504
- CountryChina
- Language:Chinese
-
Abstract:
In vitro diagnostic ( IVD) manufacturers were important suppliers of external servicesto medical laboratories .There equipment , reagents , calibration and maintenauce services played an important role in ensuring the quality of medical laboratory tests .It is also helpful for IVD manufacturers to establish and maintain a good reputation and credibility .ISO 15189:2012“Medical laboratories -Requirements for quality and competence” was issued onNovember 1, 2012, which replaced the second edition (ISO 15189:2007).Requirements related to IVD manufacturers are involved in the new edition standard .The article aimed to help medical laboratories and IVD manufacturers understand the requirements ; therefore , laboratories would know how to select suppliers based on their ability to supply external services , IVD manufacturers would know how to meet the needs of laboratories , and the cooperation between IVD manufacturers and laboratories would be facilitated .
