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 151892012“Medical laboratories -Requirements for quality and competence” was issued onNovember 1, 2012, which replaced the second edition (ISO 151892007).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 .