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ISO/IEC 17043: Conformity Assessment – General
requirements for proficiency testing
HKAS Training Course
21-22 January, 2014
Daniel Tholen, M.S.
ISO/IEC 17043&13528 Training
Tuesday: ISO/IEC 17043
– Introduction to PT Standards and ISO 17043
– Definitions
– Examples of PT schemes
– Technical requirements:
Personnel, Equipment, Accommodation
Design
Choice of Method
Operations
Data analysis
Reports, Communications
ISO/IEC 17043&13528 Training
Wednesday afternoon
– Management System Requirements
– Technical requirements: Statistical Methods
Annex B
– Quiz
– Quiz Answers and Discussion
ISO/IEC 17043&13528 Training
Wednesday morning ISO 13528, Current
and Revised
– Introduction to Statistical Standards for PT
– Reasons for revision of ISO 13528
Change in Statistical Model
– General approach – objectives for PT
– Techniques in current document that remain
– Techniques proposed for removal
– New Techniques proposed
– Examples
– Questions and Discussion
History of Standards for
Proficiency Testing
1945-1982 Interlaboratory Comparisons
– Method validation
– Material verification
– 1963 PT (US medical – CAP)
1984 ISO/IEC Guide 43 1st Edition
1993 IUPAC Harmonized Protocol
1997 ISO/IEC Guide 43-1 and 43-2
History of Standards for PT
2000: ILAC G13
– Management system from ISO/IEC Guide 25
– Technical requirements from Guide 43-1
Replace “should” with “shall”
1997-2005 ISO 13528 on Statistical
Methods for PT by ILC
2006: IUPAC Harmonized Protocol
History of Standards for PT
2007: ILAC G13
Update Management Requirements
Added language for medical PT (EQA)
2010: ISO/IEC 17043
PT is conformity assessment activity
Requirements for competence
2014(?): ISO 13528 v2
17043 Coverage
Intended to apply to traditional PT
(interlaboratory comparisons) for testing
and calibration laboratories
Applies also to non-traditional settings:
– Inspection
– Sampling
– Sensory evaluation
– Personal competence
ISO/IEC 17043 Title
Conformity assessment – General
requirements for proficiency testing
ISO/IEC 17043 Scope
This International Standard specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. These requirements are intended to be general for all types of proficiency testing schemes, and they can be used as a basis for specific technical requirements for particular fields of application.
Introduction – Types of ILC’s - PT
a. evaluation of the performance of laboratories and monitoring laboratories’ continuing performance;
b. identification of problems in laboratories and initiation of actions for improvement;
c. establishment of the effectiveness and comparability of test or measurement methods;
d. provision of additional confidence to laboratory customers;
e. identification of interlaboratory differences;
f. education of participating laboratories based on the outcomes of such comparisons;
g. validation of uncertainty claims;
Introduction – Types of ILC’s
not PT
h. evaluation of the performance characteristics of
a method;
i. assignment of values to reference materials
and assessment of their suitability for use in
specific test or measurement procedures;
Note: “h” could be a use for PT: see Journal
Accreditation and Quality Assurance, February,
2010 “The role of PT in method validation”
by the Analytical Methods Committee, Royal
Society of Chemistry (UK)
Introduction – Types of ILC’s
not PT
j. support for statements of the equivalence of
measurements of National Metrology Institutes
through "key comparisons" and supplementary
comparisons conducted on behalf of the
International Bureau of Weights and
Measurement (BIPM) and associated regional
metrology organizations.
Normative References
Documents indispensible for the
application of ISO/IEC 17043
– ISO/IEC 17000:2004, Conformity
assessment — Vocabulary and general
principles
– ISO/IEC Guide 99:2007, International
vocabulary of metrology — Basic and general
concepts and associated terms (VIM)
“indispensible for application” does not mean it is
followed in all cases – not all PT is measurement
Informative References
Documents considered as informational:
– ISO/IEC 17011
– ISO/IEC 17025
– ISO 15189
– ISO Guide 34
– ISO/IEC Guide 98 (GUM)
– ISO 13528
Annex A: Types of proficiency testing
Revised from introductory language in
ISO/IEC Guide 43-1
Discusses different types of laboratory
examinations
– Quantitative
– Qualitative (including categorical and ordinal)
– Interpretive (datasets and information)
Annex A: Sequential schemes
Common in calibration and medical
Uses reference result as assigned value.
Caution about stability of PT item across
different participants
Includes “measurement audits”
(independent evaluations).
Annex A: Simultaneous schemes
Most common, ongoing schemes
Many ways to get assigned value:
– consensus (determined after results are
returned to PT provider);
– known value (determined before results are
returned to PT provider);
Reference values
Blind (or “double blind”).
Annex A: Simultaneous schemes
Most common, ongoing schemes
Provides further explanation of NOTES in
the definition of PT
– Sequential schemes
– Simultaneous schemes
Bulk interlaboratory
Split level
Split sample
Partial process
EQA
Annex B: Statistical methods for
proficiency testing
Reference ISO 13528 and 2006 IUPAC
Harmonized Protocol
Provide further discussion of statistical
methods for qualitative and ordinal results
– Simple listing of categorical responses
– Don’t take average of numeric ordinal data
D, D%, Z score, En, zeta
ISO TC69/SC6 consulted
Annex C: Selection and Use of
Proficiency Testing
Based on Guide 43-2.
Separate sections for laboratories and for “interested parties” – Accreditation bodies
– Regulatory agencies
– Laboratory Customers
Very general guidance on recognition of competence and use of results
Considerations for accreditation bodies to be addressed by revised ILAC P9
Thank you