CSA PLUS 15189

Abstract

<strong><em>Preface</em></strong> <br>This is the second edition of CSA PLUS 15189, <em>The ISO 15189:2007 essentials &#8212; A practical handbook for implementing the ISO 15189:2007 Standard for medical laboratories</em>. It supersedes the previous edition, published in 2004 under the title <em>The ISO 15189:2003 essentials &#8212; A practical handbook for implementing the ISO 15189:2003 Standard for medical laboratories.</em> <br>This handbook provides guidance and tips on the use of the second edition of ISO 15189, <em>Medical laboratories &#8212; Particular requirements for quality and competence</em>, published in 2007. While the Standard can be used as the basis for accreditation, the primary objective of this handbook is to provide both novice and experienced quality management practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 15189:2007 and to make medical laboratory service better for patients, physicians, laboratorians, and the community. <br>CSA gratefully acknowledges the valuable work of Michael Noble, the author of this book. Dr. Noble has been a member of ISO Technical Committee 212 Working Group 1 (ISO/TC 212/WG1) since its inception and is the past chair of both the Standards Council of Canada Canadian Advisory Committee for ISO TC/212 and also the Canadian Standards Association Technical Committee Z252 on in vitro diagnostics. <br>CSA also gratefully acknowledges the contributions of Sheila Woodcock, Murielle Provencher, and John L. James as peer reviewers of this manuscript.