Quality systems have developed largely in relation to manufacturing processes. The same broad principles apply to the clinical setting. However some of the vocabulary, concepts and methods used by quality experts are unfamiliar to many clinicians and also they may not apply directly to the clinical context.

For this reason we have used simple and non-specialist terms where possible. Relevant extracts from the EU directives are shown throughout the text. One relevant definition of clinical quality assurance is:

“Improving performance and preventing problems, through planned and systematic activities including documentation, training and review.”