Investigating the suitability of ISO 15189:2007 for medical research

M.Tech. (Operations Management)Accreditation allows people to make an informed decision when selecting a laboratory. It demonstrates competence, impartiality and capability. Most South African medical laboratories are accredited or aim to be accredited to the ISO 15189 standard. Medical research laboratories are using ISO 15189 with some resistance. Nonmedical research laboratories utilise ISO 17025, which has specifically been designed for testing and calibration laboratories. The purpose of this study was to assess whether ISO 15189 is suitable for the function performed by medical research laboratories. A literature review was used to determine the current quality process in medical laboratories. A qualitative research approach was followed with one-on-one semi-structured interviews with senior laboratory personnel (N=20) and a focus group (N=1) conducted with a group of senior laboratory personnel to assess the suitability of standards in medical laboratories in South Africa and address the future needs of these laboratories with regard to quality management and accreditation. The purposeful sample included interviews with personnel who were sourced from 20 diverse South African medical laboratories that perform diagnostic, surveillance and research testing. The questions were divided into three sections. The first section dealt with the interviewee’s demographics. The second section focused on the activities of the laboratories regarding accreditation and quality management systems. The third section dealt with the opinions of managers regarding the benefits, strengths and weaknesses of being accredited to a standard, and the necessity for this. The results were evaluated with a group of specialists