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- ISO/IEC 17025 (7) (entfernen)
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ISO/IEC 17025 is the worldwide quality standard for testing and calibration laboratories. It is the basis for accreditation by an accreditation body. The current version was published in 2018.
Implementing ISO/IEC 17025 as part of laboratory quality initiatives offers both laboratory and business benefits, such as expanding the potential customer base for testing and/or calibration, increasing the reputation and image of the laboratory at national and international level, continuous improvement of the data quality and the effectiveness of the laboratory or creation of a good basis for most other quality systems in the laboratory sector, such as GxP. The main difference between a proper approach to analysis and a formal accreditation is shown in a targeted documentation, especially on the qualification of the personnel, the test equipment and the validation of the analytical methods.
Using quantitative NMR spectroscopy as an example, it is shown how accreditation can be carried out and what documentation is required. In our case, we have described the procedure in an SOP ("Determination of the quantitative composition of simple mixtures of structurally known compounds with 1H-NMR spectroscopy") and supported it with a modular system of organizational and equipment SOPs. The special feature is that the accredited method is independent for the choice of the analyte and the matrix and therefore it is possible to operate with a single validated method. In our case, we have proposed three quality levels ("leagues") with different levels of analytical effort, which differ in their measurement uncertainty, in order to simplify the workflow and analysis design.
Der Vortag gibt einen Überblick über den aktuellen Entwurf der ISO/IEC 17025 (DIS), einschließlich der inhaltlichen und formalen Änderungen, die mit der Revision einhergehen. Im zweiten Teil wird auf wichtige Neuerungen bei der Deutschen Akkreditierungsstelle, insbesondere im Umweltsektor, eingegangen.
This guideline is intended to be used as an aid to laboratories when they are managing the
use of software and computers with respect to the requirements of ISO/IEC 17025. The
working group consisted of representatives from accreditation bodies and conformity assessment
operators, specifically laboratory organisations, but also included certification
bodies, inspection bodies and metrology institutes.
Ein Qualitätsmanagement (QMS) nach DIN EN ISO/IEC 17025 [1] für ein analytisches Labor muss technische Anforderungen (s. [2]) und Managementanforderungen umsetzen. Letztere werden hier kurz vorgestellt. Als Kompetenzbestätigung durch eine unabhängige Stelle kommt heute der Akkreditierung des Labors, für die das QMS eine Voraussetzung ist, eine wesentliche Bedeutung zu.