Evolution of the Quality Concept in Analytical Laboratories

Abstract

Abstract The formal recognition of quality in the laboratory context dates from the end of the twentieth century, when the first written standards, outlining specific quality requirements, were published. Since then, and for almost 30 years, the concept of quality related to the activity of analytical laboratories has evolved significantly. It has also currently diversified according to the specific laboratory work scenario and the type and intended use of the results. This evolution is particularly noticeable in pharmaceutical laboratories that carry out quality control of drugs and medical devices. With regard to this specific subject, these laboratories are undoubtedly a step ahead of analytical laboratories that operate in other essential fields, such as food safety or environmental monitoring. This article provides an overview of analytical laboratories' concern with quality requirements that is objective although not entirely devoid of criticism. The article has been structured into sections, adopting a top‐down approach (from general to specific issues): laboratory, instruments and equipment, methods and procedures, and results. Two annexes are included: the first one summarizes the evolution of the main written standards (ISO 9001, ISO 17025 and GLP), while the second annex provides a comprehensive list of current technical standards and directives related to analytical quality laboratories.