SummaryA view of quality is given from inside an independent contract research organization (CRO) that undertakes regulated studies as well as unregulated studies and has as its primary focus on 'the project'. Focusing on the project brings into play dependency, which means that the success of the project is dependent on the company's Board, its management, and its technical and support staffs. Dependency is a factor that needs to be considered when talking quality. Some project, company, and client dependencies are given. Quality assurance and quality control play important roles in quality operations, but there is more. Quality needs to be a built-in aspect, which here is termed 'quality inherency', and not an add-on. Quality should be seen as a quality permeation system powered from the top management position; and as a quality operational system that comprises all technical and business processes, their sub-processes and interfaces, or linkages. Quality needs to be functional and regularly improved and maintained. Eight major activities are discussed that are needed to achieve quality inherency. Ten processes, their sub-processes and linkages are presented in a systems diagram as well as summarized in words. The article describes what success means to the client, the research organization's management, the project team member, and the project leader and ends with conclusions.
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