NEW QC Textbook


Producing Reliable Test Results in the Medical Laboratory

Using a Quality System Approach and ISO 15189 to Assure the Quality of Laboratory Examination Procedures

  • QC guidance for laboratories wishing to gain
    accreditation under ISO 15189
  • Insight and interpretation of key requirements
  • Practical examples of policies and procedures
  • Useful checklists for meeting basic requirements
  • Forewords by James O. Westgard, Ph.D., Shri Giridhar Gyani, Dr. Ferruccio Ceriotti, and
    Dr. Claude Giroud

Product Details

Authors: Greg Cooper and Trudy Gillions
Copyright: 2007
Format: Softcover
Pages: 80
ISBN-13: 978-0-9792857-0-7
ISBN-10: 0-9792857-0-4
Language: English

For ordering information,
contact your local
Bio-Rad office

Catalog No. 810

or order online here from


“ ‘Producing Reliable Test Results in the Medical Laboratory’ is designed to help laboratories to fulfill the requirements for getting accreditation by providing clear explanation of the clauses of the standard and how to answer them. It successfully reaches this goal using easily understandable daily wording and practical examples coming from the routine activity of medical laboratories.”

–Dr. Claude Giroud, Marketing Manager, European Quality Assurance Programs, Bio-Rad Laboratories

“Greg Cooper and Trudy Gillions provide the practical details that are needed to implement the ISO 15189 guidelines for medical laboratories, particularly the proper use and application of statistical quality control for assuring quality and competence in a laboratory.”

–James O. Westgard, Professor Emeritus, Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School

“The book. . . is very appropriate and relevant. On one hand it covers the requirements, and on the other hand it provides readers with the enabling mechanism to prepare the laboratory to comply with accreditation requirements.

–Shri Giridhar Gyani, Secretary General, Quality Council of India

“Each aspect is discussed in a systematic way, with a presentation that is schematic and simple, but complete, scientifically sound and free from any commercial bias.”

–Ferruccio Ceriotti, Diagnostica e Ricerca San Raffaele S.p.A.

“This the latest addition to Bio-Rad’s educational range and provides an excellent overview of the requirements of the ISO 15189 standard. It will be of great value to those laboratories unfamiliar with ISO documentation requirements, who will find the appendix of example policies, processes and procedures particularly useful in setting up an ISO system.”

–Robert C. Hawkins, Department of Pathology and Laboratory Medicine, Tan Tock Seng Hospital, Singapore

“I find the book specially suitable for those laboratories trying to become an accredited clinical laboratory.”

–Professor Renfeng Feng, Advisor, Clinical Laboratory Management, Shanghai Center for Clinical Laboratory

“This easy-reading book is a “how to” with a step-by-step instruction for clinical laboratorians who need to upgrade their quality system according to ISO 15189. Best of all is examples which are provided to give insight and practical guidance.”

–Associate Professor Rachana Santiyanont, President, Association of Medical Technologists of Thailand



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