PLUS 15189 (2nd ed. pub. 2010)
The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 standard for medical laboratories
History of ISO 15189
When ISO 15189 was originally proposed in 1994, it was intended to harmonize quality management procedures for medical laboratories internationally. From the first meeting held in Philadelphia in the United States, it was clear that the international community was very interested in a new, single, harmonizing Standard. Some countries had medical laboratory management programs that addressed quality systems in medical laboratories; however, with increased international travel for business and recreation, globalized medical care was becoming the norm. Medical laboratory testing was also more international, with the transfer of medical samples, laboratory testing equipment, and laboratory professionals across regions becoming more common.