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9 Managing the Quality Systems
began in England at the turn of the eighteenth and nineteenth century. It led to the
shaping of the structures of industrial production and the use of steam engines caused
a sharp increase in the quantity of produced wares. The increase in the production
scale also gave a start to actions directed at controlling the production process in order
to limit the losses of the producers—those connected to the unsatisfying quality of
the products (so-called Taylorism). This covers technical control, development of
organizational schemes, methods and scope of quality management, conceptions of
managing the quality evolved in the direction of ‘total quality,’ encompassing not only
the production line but the functioning of the entire company. Nowadays, it is believed
that the management system encompassing the functioning of the organization, as
well as the technical aspects, is the best scheme of quality management.
A high quality results from chemical measurements requires the laboratory
to be well organized; proper infrastructure and technical competencies of the
personnel are also necessary.
The development of the quality management strategy was tightly connected with
the increasingly common use of statistical methods, and a significant step was the
appearance, in 1931, of the book by Walter Shewhart, Economic Control of Quality
of Manufactured Product, in which the term statistical control of processes appeared.
Shewhart assumed that every process is laden with a certain variation and because
of that it should be constantly controlled statistically in order for it to be possible to
trace trends and prevent deviation. For the purpose of analyzing the changeability
of the process, Shewhart proposed control charts for managing quality, nowadays
called also as Shewahart’s charts. In the course of conducting of the control charts,
it is assumed that each process should stay within set tolerance limits.
Laboratories use control charts to monitor the direction of changes of selected
analytical parameters of the measuring procedure used.
9.1 Quality Management System
Quality Management System (QMS) encompasses Quality Management (QM),
Quality Assurance (QA) and Quality Control (QC), as described in the ISO 9000
standard ‘Quality Management System—Fundamentals and Vocabulary.’ The organization management system as such, including relevant requirements, is described
in the ISO 9001 standard ‘Quality Management System—Requirements,’ a document designed to be used in any institution (not necessarily a laboratory), meaning
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