A practical guide to ISO 15189 in laboratory medicine

Abstract

a good mix of theory and practical examples, and readers may select chapters that are relevant to their interest or need. I believe that the comprehensive approach to quality presented makes Quality Control in Risk Management a valuable resource for teaching the principles of quality in laboratory medicine and positions it as a useful reference during the forthcoming changes in the world of quality. This book is a timely and extremely useful publication for all medical laboratories. As stated, it really is as a practical guide for those wishing to implement the inter-national standard, ISO 15189:2012 Medical Laboratories – Requirements for quality and competence, in their own laboratory. Not only does it outline and explain the International Organisation for Standardisation (ISO) requirements, it also provides examples directly relevant to the clinical biochemistry laboratory. The book begins with a brief introductory chapter explaining the origin of ISO, the development of ISO 15189, the normative and informative elements of a standard and the importance of the wording they employ. The main sub clauses of ISO 15189 are then graphically summarised in a process-based model of a Quality Management System (QMS) which helps clar-ify the inter-relationships with the medical laboratory. Chapter two begins to explore the definition of qual-ity and the underlying principles of quality manage-ment, with reference to Six Sigma and DMAIC (Define, Measure, Analyse, Improve and Control) methodology. The author also introduces the fictional laboratory at St Elsewhere's Regional Hospital Trust, which is used throughout the book to illustrate the requirements of ISO 15189. Chapters three to eight cover organisation and management responsibility, QMS, personnel, environment and equipment and pre-and postexamination in detail. Of particular interest are chapters nine and ten, as they cover concepts that are perhaps less familiar to the average biochemistry laboratory. Two approaches to measurement uncertainty are outlined in chapter nine, with the author recommending that laboratories use the top-down approach and determine measurement uncer-tainty from quality control material. Although some useful references are provided, it may have been helpful if the author had covered this topic in more detail. The final chapter, 'Evaluation & Continual Improvement', covers the concept of corrective and preventive actions and highlights the differences between the two. It is a shame that the importance of assessing the effectiveness of corrective and preventive actions was not given more emphasis. Attention should also be drawn to the appendices. Appendix A cross references the ISO standards to chapters in the text and also to the 'ideal standard', which makes dipping in to the book straightforward. Appendix B contains excerpts from St Elsewhere's Quality Manual. The bibliography provides an exten-sive list of additional resources, neatly cross referenced by chapter. Of particular value are references to the US CLIA (Clinical Laboratory Improvement Amendments) Regulations and the Australian National Pathology Accreditation Advisory Council. In conclusion, this book is well written, logical and easy to read. The author's explanations and effective translation of what is required to meet the ISO 15189 standards are invaluable. Chapters can also be read in isolation which will help, as I suspect that the topic of ISO may be a dry one for many readers. While I hesi-tate to say that I enjoyed reading this book, I did find it extremely useful. Essentially, it is a DIY guide to ISO and as such a 'must-have' book for all medical laboratories.