Quality is a difficult word to define, and it is one that is subjective and often contested; quality is also perceptual, conditional, and often understood differently by different people. The generally accepted definition is ‘a concept common to most definitions involves meeting or exceeding customers’ needs’, and in the case of pharmaceuticals and healthcare the customer of greatest importance is the patient.
Quality can also be thought of as both ‘relative’ and ‘unique’. As a relative concept, this is realized by comparing two things – either two things against one another or something against a standard. In terms of quality as something unique, this is subjective for what constitutes quality to one individual may not be shared or fully understood by another individual.
The ISO 9000 series discusses four facets of product quality, which are:
• Quality due to definition of needs for the product: Defining and updating the product to meet marketplace requirements and opportunities.
• Quality due to product design: Designing into the product the characteristics that enable it to meet marketplace requirements and opportunities, such as features that influence intended functionality and features that influence the robustness of product performance under variable conditions of production and use.
• Quality due to conformance to product design.
• Quality due to product support throughout the product life cycle.
Quality is interrelated to organizational success and customer (or patient) satisfaction