Fischer JC ,
Abels-van Overveld MJLC ,
Steinberger PE ,
Uitert S van
159 p
in Dutch
1994
Toon Nederlands
English Abstract Automated systems act more and more upon the quality of
data collected and processed in laboratory studies. Related problems are
often very specific. But quality assurance standards for laboratories
include little guidance in the area of automated systems. For this reason,
the National Institute of Public Health and Environmental Protection
initiated the development of internal guidelines and possible measures. Its
purpose is to support laboratories of the institute to improve and maintain
the quality of automated systems. This report is a modified version of the
first phase report of the RIKWIN project. The most important modifications
are the addition of a number of possible measures to each guideline and the
updating of the contents of the five chapters. Two areas had priority in
this project. First, attention was payed to the integrity of the raw data.
Second, we choosed for existing systems, without paying special attention to
the important area of developing new systems. In this report, an
information system consists of several parts. We call this parts objects.
Each object can be assessed on several aspects. Some aspects are relevant
to more than one object, so we built a matrix for the combination of objects
and aspects. This matrix shows what we feel as essential for the quality of
an information system. For every relevant object-aspect combination, a
guideline is developed, indicating what should be done to assure quality.
Applicable measures were added to eacht guideline, in order to explain how
compliance can be achieved. We distinguish between preventive, detective
and corrective measures. It is up to the laboratory to decide whether
combinations are relevant or not in relation to the tasks of the laboratory.
It is very important to support these decisions with good argumentation.
Several standards for quality assurance in laboratories exist. The amount
of guidance of this standards with respect to information systems differs.
It is not simple to apply the guidelines and measures in the area of
information systems. This report can assist laboratories of the institute
in this complex area.
