The need for a quality standard for assurance in medical research laboratories

The objective of this article is to show the results of a research study conducted to evaluate the need for a quality standard specific for medical research laboratories based on the shortfalls of ISO 15189 when used for this purpose. A qualitative research methodology was used, which comprised of collecting data from 20 well-qualified and experienced medical laboratory personnel by means of interviews based on a framework developed from a literature review. The data were analysed by means of a thematic technique and the results were verified by a team of medical researchers. The seven themes arising from the analyses were inflexibility; ambiguity; unfair requirements; inappropriate focus; inadequacy for research; renewal; and acceptance for accreditation. The results indicated that the ISO 15189 standard in its present content does not totally suit medical research laboratories and shows support for the development of a standard specific for research laboratories.