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