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Published on Laboratory Quality Stepwise Implementation tool (https://extranet.who.int/lqsi)
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What is quality management and what is a quality management system?
A laboratory, just like any other organization, consists of numerous processes in which inputs are turned into
outputs through one or more process steps. The core process of the laboratory is the primary process
consisting of three stages: the pre-analytical stage (the sample is collected, received at the laboratory,
registered and processed), the analytical stage (the actual laboratory test is performed and the result is
recorded), and the post-analytical stage (the result is authorized, reported and archived and the sample is
A Quality Management System affects each single process of the laboratory and consists of several layers.
You can see this as a pyramid:
The basis of the pyramid consist of Inspection. This is nothing more than arbitrary (-partly subconcious-)
inspection of work by the laboratory technologist him/herself. Detection of errors depend on alertness of the
Active, more structured, concious and rational inspection of process performance is called quality control.
This is the implementation of control steps at strategic logical points in each process of the laboratory to
monitor correct performance and quality output. This enables the laboratory to be certain that its final output,
i.e. the test result, is of good quality. With quality control errors can only be detected after they have already
Quality Management System
A quality management system can be described as a set of building blocks needed to control, assure and
manage the quality of the laboratory's processes. A system used in this tool is the framework of 12 building
blocks, called quality system essentials (QSEs).
By ensuring that all the processes related to the QSEs perform correctly, quality can be assured. For
example: to control and assure quality, go