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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 ILCs - 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 ILCs

    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 ILCs

    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

    Dont 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

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