ISO 17043-2010 pdf free download

ISO 17043-2010 pdf free download.Conformity assessment — General requirements for proficiency testing
Evaluation de Ia con formité — Exigences genérales concemant les essais d’aptitude.
4.4.3.5 When proficiency test items from previous rounds are retained for future use, the property values to be determined in the proficiency testing scheme shall be confirmed by the proficiency testing provider prior to distribution.
4.4.3.6 In circumstances where homogeneity and stability testing is not feasible, the proficiency testing provider shall demonstrate that the procedures used to collect, produce, package and distribute the proficiency test items are sufficient for the purpose of the proficiency testing,
4.4.4 StatistIcal design
4.4.4.1 StatIstical designs shall be developed to meet the objectives of the scheme, based on the nature of the data (quantitative or qualitative, including ordinal and categorical), statistical assumptions, the nature of errors, and the expected number of results (see B.3.2.2).
NOTE 1 Statistical design covers the p’ocess of planning, collection, analysis and reporting of the proficiency testing scheme data, Statistical designs are often based on stated objectives for the proficiency testing scheme, such as detection of certain types of errors with specified power or determination of assigned values with specified measurement uncertainty.
NOTE 2 Data analysis methods could vary from the very simple (e.g. descriptive statistics) to the complex, using statistical models with probabilistic assumptions or combinations of results for different proficiency test items.
NOTE 3 In cases where the proficiency testing scheme design is mandated by a specification given by, for example. a customer, regulatory authority or accreditation body, the statistical design and data analysis methods can be taken directly from the specification.
NOTE 4 In the absence of reliable Information needed to produce a statistical design, a preliminary Interlaboratory comparison can be used,
4.4,4.2 The proficiency testing provider shall document the statistical design and data analysis methods to be used to identify the assigned value and evaluate participant results, and shall provide a description of the reasons for their selection and assumptions upon which they are based. The proficiency testing provider shall be able to demonstrate that statistical assumptions are reasonable and that statistical analyses are carried out in accordance with prescribed procedures.
4.4.4.3 In designing a statistical analysis, the proficiency testing provider shall give careful consideration to the following:
a) the accuracy (trueness and precision) as well as the measurement uncertainty required or expected for each measurand or characteristic in the proficiency testing;
b) the minimum number of participants in the proficiency testing scheme needed to meet the objectives of the statistical design; in cases where there is art insufficient number of participants to meet these objectives or to produce statistically meaningful analysis of results, the proficiency testing provider shall document, and provide to participants, details of the alternative approaches used to assess participant performance;ISO 17043-2010 pdf free download.