Tests performed by clinical laboratories have markedly improved in accuracy, reproducibility, and speed. There is more agreement between laboratories. This change has occurred due to technological advances and the introduction of quality management systems (QMSs) in the laboratories. Dependence on laboratory tests has increased; simultaneously the clinicians and patients have higher expectations.
To meet these challenges a laboratory must establish a QMS and acquire competence to perform the task. A third-party audit by an independent body not only ensures that both these have been attained, but also instils confidence in laboratory personnel and clients. There are several reputed accreditations which specify the requirements of the QMS and competence of personnel, and, following a rigorous audit, certify the laboratory that meets these requirements. Conformity with the requirements of ISO 15189 is gradually becoming more popular the world over, and many countries have established accreditation bodies for this standard.
Most of the contributors to this book have been assessing clinical laboratories for accreditation. They have observed that many well qualified and experienced Laboratory Directors find it difficult to comprehend the requirements Sometimes even the assessors do not fully understand the intent of the clauses.
The book is designed to help everyone understand the clauses of the ISO 15189:2012 Standard. Based on their experience, the authors have provided several examples of nonconformities that make it easier to understand the intent of the clause. It is our objective that this book helps laboratories find a smoother path to accreditation. It is also our hope that laboratories already accredited will use it to understand the clauses better, and in their pursuit of continual improvement.
We have frequently used the pronouns “he”, “him”, and “his” when referring to various persons in their official capacities. We wish to assure our readers that this was done purely to avoid the cumbersome use of “he or she”, “him or her”, and “his or hers”. These pronouns are intended to be gender-neutral, and do not in any way imply a bias on the part of the authors. The English language sorely needs a good all-purpose pronoun!
Swaroop Krishan Sood
Rajat Mukherjee
Suneet Sood