ConfLab Founder/ IQSC-USP Professor / CGCRE-Inmetro Auditor
“It is not enought to do your best; you must know what to do, and then do your best.”
W. Edwards Deming
It is presently unthinkable to not take into account the need (sometimes mandatory) to implement Quality Management in Laboratories, either routinely or for research (basic and applied). Given that many countries have their own requirements regarding their mandatory implementation of Laboratory Quality Management Systems, this reality currently has a global reach to ensure the reliability of analytical results, especially since the effects of an analytical result can have major impacts on the environmental, pharmaceutical, forensic, clinical analysis, food areas, and so forth.
The formal recognition of the implementation of a Laboratory Quality Management System, such as ISO/IEC17025 or ISO15189, is performed by the national accreditation bodies of different countries, which audit and assess these systems. In order to reach mutual recognition between the assessments of different countries, entities such as ILAC (International Laboratory Accreditation Cooperation) promote mutual recognition agreements with their Full Members. As for the entities from different countries which are ILAC members and associates, there are currently approximately 36.500 testing laboratories and 8.500 calibration laboratories which implement the system and are accredited in the Quality Management System according to the ISO/IEC 17025 standard, and also 4.500 accredited clinical laboratories in the ISO 15189 standard.
News from the third edition
“Reliability of the analytical results is an obligation for any laboratory (research or routine), because the effects of these results can be devastating.”
Prof. Dr. Igor R. B. Olivares
The first edition (2005) of this book was launched at a time when Quality Management was in the spotlight, mainly due to the pressure from Laboratories to ensure their reliable results. A few years later, already in the 2nd edition (2009), it was clear that the pressure seen at that time was not merely a fleeting trend, given the exponential growth in Quality Management implementation procedures, which resulted in the improvement of Quality Management tools, its laws, updated standards, and other specifics. In this 3rd edition (again revised and expanded), it is perceived as inconceivable to not consider the need (and sometimes mandatory) to implement Quality Management in Laboratories, either routinely (as for instance in laboratories for medical, chemical, mechanical, biological tests, etc.) or for research (basic and applied).
In light of the latest findings for Laboratory Quality Management, in this English edition of the book I intend to present this data in an informative manner, within the operating framework of a Management System, and in line with the proposal of being a book that provides assistance to the new professionals in this area (highlighting, for example, the evolution of concepts, needs and basic structure of a Quality Management System), as well as assist experts seeking new tools for Laboratory Quality Management (highlighting, for example, the Analytical Quality Assurance Cycle and Quality indicators concepts, in addition to the numerous tools applied to auditing, training, corrective action and others).