Quality Management and Quality Assurance in Medical Laboratories

Background

In most economic activities quality and productivity issues are usually discussed in figures reflecting economic and quality indicators. A lot of aspects may be of a similar or an analogous relevance in all sectors. However, in the medical sector as well as in cases related to health and safety, the quality of services provided has quite a different significance.

There is very often a discussion on the cost of quality; the higher cost of high quality is considered as a disadvantage; however, what about the high cost of non-quality? Experience clearly illustrates that this cost is much higher even when corrective actions are possible, realistic and adequately efficient. To this end, a simplified approach “high quality or low cost?” seems to be the wrong question which may lead to a wrong answer, especially in times of economic recession. The cost of failure and lack of reliability in medical laboratories cannot be estimated in figures and statistics. Although the economic aspects play their important and decisive role in the medical sector as well, the reliability of the results from medical laboratories is a must and a task for which no compromise can be allowed.

Laboratories in general represent the most widely known institution in the quality infrastructure in a country; other bodies, namely certification and inspection bodies are also important parts of the quality infrastructure. They all come under the title of “conformity assessment bodies” since they all contribute to the named task. Laboratories focus on two main activities, testing and calibration, the latter being an activity of high importance to all conformity assessment bodies since it contributes to the documentation of the metrological traceability, thus providing the basis for the “common measuring language” required in all measuring applications.

Measurements are carried out by laboratories. In almost all cases, measurements of various parameters and other factors are necessary. You can neither make an assessment nor an evaluation of compliance to set criteria without carrying out appropriate measurements. In the case of measurements, the meaning of quality includes reliability:

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  What about the reliability of the measurement?

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  What about the cost of non-reliable measurements?