Interpretation of ISO 15189:2012“Medical laboratories-Requirements for quality and competence” -Requirements for IVD manufacturers / 中华检验医学杂志

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 .