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It are often employed by medical laboratories in developing their quality management systems and assessing their own competency. It may be used for confirming or recognizing the competency of medical laboratories by laboratory customers, regulation authorities and enfranchisement bodies.

This commonplace is for Medical laboratories that outline needs for quality and competency. this can be a world commonplace that specifies the standard management system needs specific to medical laboratories. the quality was developed by the world organization for Standardization's Technical Committee 212 (ISO/TC 212). The ISO 15189 is predicated on ISO/IEC 17025 and ISO 9001; it's a singular document that takes into thought the particular needs of the medical setting and therefore the importance of the medical laboratory to patient care.