Copyright © 2003 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All rights reserved.
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The history of medical laboratory accreditation has developed in two major ways. In some countries, emphasis has, in the past, been laid upon ensuring that what happens at the laboratory bench and in other parts of the laboratory is carried out efficiently, to the benefit of the users, in accordance with appropriate standards, and with good documentation; the role of higher management in this process has had a relatively minor role, merely ensuring that sufficient staff, equipment and other resources are available and supplied when required. In other countries medical laboratory accreditation has been based on ISO standards of quality management; the philosophy being that if the management is good then the rest of the laboratory will be good. These two threads have now been drawn together with the publication, after lengthy discussion, of the new ISO Standard 15189:2003 “Medical laboratories -- Particular requirements for quality and competence” (or “Quality Management in the Medical Laboratory” as it was initially called).
The onset of this new ISO Standard - together with the decision of the United Kingdom accreditation service to modify its requirements to take into account this new standard – has stimulated David Burnett to update his previous textbook on medical laboratory accreditation.
Those who are familiar with the first book will be pleased to know that the strong points of that publication are continued in the new version. It includes chapters on “Recognition of medical laboratories”; “The changing world of standards”; Quality management for the medical laboratory”; “Organisation and management responsibility”; “A quality management system and documentation”; “Personnel”; “Premises, health, safety and welfare”; “Equipment and diagnostic systems, data and information systems”; “Pre- and post-examination processes”; “Examination processes”; and “Evaluation and quality improvement”.
Also as the previous version, these chapters are full of clear diagrams, and include a number of excellent examples of the way in which documentation and procedures should be set out. There is also a full list of references for further reading and a good index.
Dr David Burnett has been involved in medical laboratory accreditation for a significant number of years and his experience is shown on many of the pages of this book. Whilst it is not essential for all laboratories to follow Dr Burnett’s guidelines exactly in all respects, this book provides an excellent starting point for laboratories to begin their accreditation procedures or to modify them in the light of the new ISO standard.
This is a book that all laboratory staff should read in order to ensure that quality matters in the laboratory are identified and acted upon. It will be a great help to all involved in medical laboratory accreditation.
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