ISO 15189 3rd Edition, “Medical laboratories – Requirements for quality and competence,” has just been released and it’s available now from Document Center Inc. The 58-page standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
This new update cancels and replaces the second edition (ISO 15189:2007), which has been technically revised. Annex B provides a correlation (relationship) between the second and third editions. Sections of the standard have been renamed or expanded on to reflect a improvements to the text.
ISO 15189:2012 is based on both the ISO/IEC 17025 and the ISO 9001 and continues the alignment established in ISO/IEC 17025:2005. Annex A details the correlation between the clauses and subclauses of this third edition of ISO 15189 and those of ISO 9001:2008 and of ISO/IEC 17025:2005.
This International Standard is not intended to be used for the purposes of certification, however a medical laboratory’s fulfilment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results. If a laboratory seeks accreditation, it should select an accrediting body which operates in accordance with ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.
All ISO, IEC and ISO/IEC standards are available from Document Center Inc. You can purchase them at our website, www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Territorial restrictions apply. We look forward to working with you.