CSA PLUS 15189 (2nd ed. pub. 2010)

This is the second edition of CSA PLUS 15189, The ISO 15189:2007 essentials – A practical handbook for implementing the ISO 15189:2007 Standard for medical laboratories. It supersedes the previous edition, published in 2004 under the title The ISO 15189:2003 essentials – A practical handbook for implementing the ISO 15189:2003 Standard for medical laboratories.

Introduction

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.