EffiChem - Method Validation Software
 


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EN ISO/IEC 17 025: Requirements for the Estimation of Uncertainty

A calibration laboratory, or a testing laboratory performing its own calibrations, shall have and apply a procedure to estimate the uncertainty of measurement for all calibrations and for all types of calibration. The standard provides further explanation given below.

Testing laboratories shall also have and apply procedures for estimating uncertainties of measurement, except when the test methods preclude such rigorous calculations. In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory shall at least attempt to identify all the components of uncertainty and make the best possible estimation, and ensure that the form of reporting does not give an exaggerated impression of accuracy.

In those cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied this clause by following the reporting instructions.

When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account using accepted methods of analysis.

Sources contributing to the uncertainty include, but are not necessarily limited to, the reference standards and reference materials used, methods and equipment used, the environmental conditions, the condition of the item being tested or calibrated and the operator.

The predicted long-term behavior of the tested and/or calibrated item is normally not taken into account when estimating the measurement uncertainty.

For further information see ISO 5725-1 and the Guide to the Expression of Uncertainty in Measurement (see bibliography).


Now available: Version 3.0!

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Main Features and Improvements
  • Software validation requirements met
  • Emphasis on statistical methods to validate testing/calibration methods, estimate uncertainties, develop control charts and calibration models, and to enable inter-laboratory comparison
  • Database of samples, equipment calibrations, standards, chemicals, documents and complaints included
  • Automated data evaluation and hypothesis testing
  • Automated generation of test reports in numerical and graphical form
  • Easy-to-use, intuitive handling based on Microsoft standards, feasible for all laboratory personnel
  • And much more...

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