Abstract
M.Tech. (Operations Management)
It has become a trend for organisations to implement and certify quality systems. The
most common quality system that organisations currently implement is ISO 9001.
Certification to ISO 9001 has in recent times been used as a marketing tool to enter
new markets. Nowadays, customers expect their suppliers and potential suppliers to
be certified to ISO 9001. It has become a primary requirement for doing business, and
customers now demand it. There have been various studies conducted to establish the
advantages of ISO 9001 and its impact on organisational performance.
Laboratories are no exception to this developing trend. They are implementing
laboratory quality standards like ISO 17025 and the Organisation for Economic
Cooperation and Development Good Laboratory Practice (OECD GLP). Some
laboratories are now applying for certification of compliance to laboratory standards.
Implementing and certifying laboratory systems is an exercise that comes at a cost.
The exercise is demanding in terms of human resources, time and capital. There has
not been a study conducted to evaluate the impact of these systems on the operational
performance of laboratories. This is the reason that resulted in identification of the
need to conduct the study.
A qualitative research approach was pursued in conducting the study, where the
researcher investigated the impact of laboratory quality standards on the operational
performance of commercial and non-commercial laboratories. Operational
performance in this study is defined as health and safety; supplier selection and
performance; human resources; customer satisfaction and profitability. Data was
collected through interviews, and was then summarised, and analysed in order to
address the research problem.
Based on the data collected, it was concluded there is no notable difference in the
performance of laboratories with or without quality assurance systems such as ISO
17025 and OECD GLP.