ISO 13528:2015
Statistical methods for use in proficiency testing by interlaboratory comparison
ISO 13528:2015 provides detailed descriptions of statistical methods for proficiency testing providers to use to design proficiency testing schemes and to analyse the data obtained from those schemes. It provides recommendations on the interpretation of proficiency testing data by participants in such schemes and by accreditation bodies.
The procedures in ISO 13528:2015 can be applied to demonstrate that the measurement results obtained by laboratories, inspection bodies, and individuals meet specified criteria for acceptable performance.
ISO 13528:2015 is applicable to proficiency testing where the results reported are either quantitative measurements or qualitative observations on test items.
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Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
4.1 General requirements for statistical methods
4.2 Basic model
4.3 General approaches for the evaluation of performance
5 Guidelines for the statistical design of proficiency testing schemes
5.1 Introduction to the statistical design of proficiency testing schemes
5.2 Basis of a statistical design
5.3 Considerations for the statistical distribution of results
5.4 Considerations for small numbers of participants
5.5 Guidelines for choosing the reporting format
6 Guidelines for the initial review of proficiency testing items and results
6.1 Homogeneity and stability of proficiency test items
6.2 Considerations for different measurement methods
6.3 Blunder removal
6.4 Visual review of data
6.5 Robust statistical methods
6.6 Outlier techniques for individual results
7 Determination of the assigned value and its standard uncertainty
7.1 Choice of method of determining the assigned value
7.2 Determining the uncertainty of the assigned value
7.3 Formulation
7.4 Certified reference material
7.5 Results from one laboratory
7.6 Consensus value from expert laboratories
7.7 Consensus value from participant results
7.8 Comparison of the assigned value with an independent reference value
8 Determination of criteria for evaluation of performance
8.1 Approaches for determining evaluation criteria
8.2 By perception of experts
8.3 By experience from previous rounds of a proficiency testing scheme
8.4 By use of a general model
8.5 Using the repeatability and reproducibility standard deviations from a previous collaborative study of precision of a measurement method
8.6 From data obtained in the same round of a proficiency testing scheme
8.7 Monitoring interlaboratory agreement
9 Calculation of performance statistics
9.1 General considerations for determining performance
9.2 Limiting the uncertainty of the assigned value
9.3 Estimates of deviation (measurement error)
9.4 z scores
9.5 z′ scores
9.6 Zeta scores (ζ)
9.7 En scores
9.8 Evaluation of participant uncertainties in testing
9.9 Combined performance scores
10 Graphical methods for describing performance scores
10.1 Application of graphical methods
10.2 Histograms of results or performance scores
10.3 Kernel density plots
10.4 Bar-plots of standardized performance scores
10.5 Youden Plot
10.6 Plots of repeatability standard deviations
10.7 Split samples
10.8 Graphical methods for combining performance scores over several rounds of a proficiency testing scheme
11 Design and analysis of qualitative proficiency testing schemes (including nominal and ordinal properties)
11.1 Types of qualitative data
11.2 Statistical design
11.3 Assigned values for qualitative proficiency testing schemes
11.4 Performance evaluation and scoring for qualitative proficiency testing schemes
Annex A (normative) Symbols
Annex B (normative) Homogeneity and stability of proficiency test items
Annex C (normative) Robust analysis
Annex D (informative) Additional guidance on statistical procedures
Annex E (informative) Illustrative examples
Bibliography
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Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
4.1 General requirements for statistical methods
4.2 Basic model
4.3 General approaches for the evaluation of performance
5 Guidelines for the statistical design of proficiency testing schemes
5.1 Introduction to the statistical design of proficiency testing schemes
5.2 Basis of a statistical design
5.3 Considerations for the statistical distribution of results
5.4 Considerations for small numbers of participants
5.5 Guidelines for choosing the reporting format
6 Guidelines for the initial review of proficiency testing items and results
6.1 Homogeneity and stability of proficiency test items
6.2 Considerations for different measurement methods
6.3 Blunder removal
6.4 Visual review of data
6.5 Robust statistical methods
6.6 Outlier techniques for individual results
7 Determination of the assigned value and its standard uncertainty
7.1 Choice of method of determining the assigned value
7.2 Determining the uncertainty of the assigned value
7.3 Formulation
7.4 Certified reference material
7.5 Results from one laboratory
7.6 Consensus value from expert laboratories
7.7 Consensus value from participant results
7.8 Comparison of the assigned value with an independent reference value
8 Determination of criteria for evaluation of performance
8.1 Approaches for determining evaluation criteria
8.2 By perception of experts
8.3 By experience from previous rounds of a proficiency testing scheme
8.4 By use of a general model
8.5 Using the repeatability and reproducibility standard deviations from a previous collaborative study of precision of a measurement method
8.6 From data obtained in the same round of a proficiency testing scheme
8.7 Monitoring interlaboratory agreement
9 Calculation of performance statistics
9.1 General considerations for determining performance
9.2 Limiting the uncertainty of the assigned value
9.3 Estimates of deviation (measurement error)
9.4 z scores
9.5 z′ scores
9.6 Zeta scores (ζ)
9.7 En scores
9.8 Evaluation of participant uncertainties in testing
9.9 Combined performance scores
10 Graphical methods for describing performance scores
10.1 Application of graphical methods
10.2 Histograms of results or performance scores
10.3 Kernel density plots
10.4 Bar-plots of standardized performance scores
10.5 Youden Plot
10.6 Plots of repeatability standard deviations
10.7 Split samples
10.8 Graphical methods for combining performance scores over several rounds of a proficiency testing scheme
11 Design and analysis of qualitative proficiency testing schemes (including nominal and ordinal properties)
11.1 Types of qualitative data
11.2 Statistical design
11.3 Assigned values for qualitative proficiency testing schemes
11.4 Performance evaluation and scoring for qualitative proficiency testing schemes
Annex A (normative) Symbols
Annex B (normative) Homogeneity and stability of proficiency test items
Annex C (normative) Robust analysis
Annex D (informative) Additional guidance on statistical procedures
Annex E (informative) Illustrative examples
Bibliography