ISO/IEC 17043:2010 General requirements for proficiency testing

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ISO/IEC 17043:2010 General requirements for proficiency testing

Description

ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing: The use of interlaboratory comparisons is increasing internationally. This International Standard provides a consistent basis to determine the competence of organizations that provide proficiency testing.

Abbreviation: ISO/IEC 17043:2010

Reference: https://www.iso.org/obp/ui/#iso:std:29366:en


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Publicly available informative sections of standards

Introduction
Interlaboratory comparisons are widely used for a number of purposes and their use is increasing internationally. Typical purposes for interlaboratory comparisons include:
  1. evaluation of the performance of laboratories for specific tests or measurements and monitoring laboratories' continuing performance;
  2. identification of problems in laboratories and initiation of actions for improvement which, for example, may be related to inadequate test or measurement procedures, effectiveness of staff training and supervision, or calibration of equipment;
  3. establishment of the effectiveness and comparability of test or measurement methods;
  4. provision of additional confidence to laboratory customers;
  5. identification of interlaboratory differences;f) education of participating laboratories based on the outcomes of such comparisons;
  6. validation of uncertainty claims;h) evaluation of the performance characteristics of a method — often described as collaborative trials;
  7. assignment of values to reference materials and assessment of their suitability for use in specific test or measurement procedures;
  8. 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.
Proficiency testing involves the use of interlaboratory comparisons for the determination of laboratory performance, as listed in a) to g) above. Proficiency testing does not usually address h), i) and j) because laboratory competence is assumed in these applications, but these applications can be used to provide independent demonstrations of laboratory competence. The requirements of this International Standard can be applied to many of the technical planning and operational activities for h), i) and j).
The need for ongoing confidence in laboratory performance is not only essential for laboratories and their customers but also for other interested parties, such as regulators, laboratory accreditation bodies and other organizations that specify requirements for laboratories. ISO/IEC 17011 requires accreditation bodies to take account of laboratories' participation and performance in proficiency testing. There is a growing need for proficiency testing for other conformity assessment activities, such as inspection or product certification. Most of the requirements in this International Standard apply to those evolving areas, especially regarding management, planning and design, personnel, assuring quality, confidentiality, and other aspects, as appropriate.
This International Standard has been prepared to provide a consistent basis for all interested parties to determine the competence of organizations that provide proficiency testing. In doing so it replaces both parts of ISO/IEC Guide 43:1997. ISO/IEC Guide 43 included not only guidance on development and operation of proficiency testing and selection and use of proficiency testing by laboratory accreditation bodies, but also useful descriptions of typical types of proficiency testing. This International Standard has preserved and updated the principles for the operation of proficiency testing described in ISO/IEC Guide 43 and has retained in Annexes A to C information on typical types of proficiency testing schemes, guidance on appropriate statistical methods, selection and use of proficiency testing schemes by laboratories, accreditation bodies, regulatory bodies, and other interested parties.
Terms and definitions
Assigned value: value attributed to a particular property of a proficiency test item.
Coordinator: one or more individuals with responsibility for organizing and managing all of the activities involved in the operation of a proficiency testing scheme.
Customer: organization or individual for which a proficiency testing scheme is provided through a contractual arrangement.
Interlaboratory comparison: organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions.
Outlier: observation in a set of data that appears to be inconsistent with the remainder of that set. An outlier can originate from a different population or be the result of an incorrect recording or other gross error.
Participant: laboratory, organization or individual that receives proficiency test items and submits results for review by the proficiency testing provider. In some cases, the participant can be an inspection body.
Proficiency testing: evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons. For the purposes of this International Standard, the term “proficiency testing” is taken in its widest sense and includes, but is not limited to:
  1. quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item;
  2. qualitative scheme — where the objective is to identify or describe one or more characteristics of the proficiency test item;
  3. sequential scheme — where one or more proficiency test items are distributed sequentially for testing or measurement and returned to the proficiency testing provider at intervals;
  4. simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement within a defined time period;
  5. single occasion exercise — where proficiency test items are provided on a single occasion;
  6. continuous scheme — where proficiency test items are provided at regular intervals;
  7. sampling — where samples are taken for subsequent analysis;
  8. data transformation and interpretation — where sets of data or other information are furnished and the information is processed to provide an interpretation (or other outcome).
Some providers of proficiency testing in the medical area use the term “External Quality Assessment (EQA)” for their proficiency testing schemes, or for their broader programmes, or both.
Proficiency test item: sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing.
Proficiency testing provider: organization which takes responsibility for all tasks in the development and operation of a proficiency testing scheme.
Proficiency testing round: single complete sequence of distribution of proficiency test items, and the evaluation and reporting of results to the participants.
Proficiency testing scheme: proficiency testing designed and operated in one or more rounds for a specified area of testing, measurement, calibration or inspection. A proficiency testing scheme might cover a particular type of test, calibration, inspection or a number of tests, calibrations or inspections on proficiency test items.
Robust statistical method: statistical method insensitive to small departures from underlying assumptions surrounding an underlying probabilistic model.
Standard deviation for proficiency assessment measure of dispersion used in the evaluation of results of proficiency testing, based on the available information. The standard deviation applies only to ratio and differential scale results. Not all proficiency testing schemes evaluate proficiency based on the dispersion of results.
Subcontractor: organization or individual engaged by the proficiency testing provider to perform activities specified in this International Standard and that affect the quality of a proficiency testing scheme. The term “subcontractor” includes what many proficiency testing providers call collaborators.
Metrological traceability: property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. For this definition, a “reference” can be a definition of a measurement unit through its practical realization, or a measurement procedure including the measurement unit for a non-ordinal quantity, or a measurement standard. Metrological traceability requires an established calibration hierarchy. Specification of the reference must include the time at which this reference was used in establishing the calibration hierarchy, along with any other relevant metrological information about the reference, such as when the first calibration in the calibration hierarchy was performed. For measurements with more than one input quantity in the measurement model, each of the input quantity values should itself be metrologically traceable and the calibration hierarchy involved may form a branched structure or a network. The effort involved in establishing metrological traceability for each input quantity value should be commensurate with its relative contribution to the measurement result. Metrological traceability of a measurement result does not ensure that the measurement uncertainty is adequate for a given purpose or that there is an absence of mistakes. A comparison between two measurement standards may be viewed as a calibration if the comparison is used to check and, if necessary, correct the quantity value and measurement uncertainty attributed to one of the measurement standards. The ILAC considers the elements for confirming metrological traceability to be an unbroken metrological traceability chain to an international measurement standard or a national measurement standard, a documented measurement uncertainty, a documented measurement procedure, accredited technical competence, metrological traceability to the SI, and calibration intervals (see ILAC P-10:2002). The abbreviated term “traceability” is sometimes used to mean “metrological traceability” as well as other concepts, such as “sample traceability” or “document traceability” or “instrument traceability” or “material traceability”, where the history (“trace”) of an item is meant. Therefore, the full term of “metrological traceability” is preferred if there is any risk of confusion [SOURCE: ISO/IEC Guide 99:2007, definition 2.41].
Measurement uncertainty: non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used. Measurement uncertainty includes components arising from systematic effects, such as components associated with corrections and the assigned quantity values of measurement standards, as well as the definitional uncertainty. Sometimes estimated systematic effects are not corrected for but, instead, associated measurement uncertainty components are incorporated. The parameter may be, for example, a standard deviation called standard measurement uncertainty (or a specified multiple of it), or the half-width of an interval, having a stated coverage probability. Measurement uncertainty comprises, in general, many components. Some of these may be evaluated by Type A evaluation of measurement uncertainty from the statistical distribution of the quantity values from series of measurements and can be characterized by standard deviations. The other components, which may be evaluated by Type B evaluation of measurement uncertainty, can also be characterized by standard deviations, evaluated from probability density functions based on experience or other information. In general, for a given set of information, it is understood that the measurement uncertainty is associated with a stated quantity value attributed to the measurand. A modification of this value results in a modification of the associated uncertainty [SOURCE: ISO/IEC Guide 99:2007, definition 2.26].


Normative references

ISO/IEC 17000:2004(en) Conformity assessment — Vocabulary and general principles - selected publicly available informative sections of standards
Some of the terms included in this International Standard relate to concepts it was considered essential to define. Others it was thought helpful to explain.
Accreditation: third-party attestation related to a conformity assessment body conveying formal demon­stration of its competence to carry out specific conformity assessment tasks. The term “accreditation” is now applicable only to attestation regarding a conformity assessment body.
Approval: permission for a product or process to be marketed or used for stated purposes or under stated conditions. Approval can be based on fulfilment of specified requirements or completion of specified procedures.
Attestation: issue of a statement, based on a decision following review, that fulfilment of specified require­ments has been demonstrated. The resulting statement, referred to in this International Standard as a “statement of conformity”, conveys the assurance that the specified requirements have been fulfilled. Such an assurance does not, of itself, afford contractual or other legal guarantees.
Audit: systematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified require­ments are fulfilled. Whilst “audit” applies to management systems, “assessment” applies to conformity assessment bodies as well as more generally.
Certification: third-party attestation related to products, processes, systems or persons. Certification of a management system is some­times also called registration. Certification is applicable to all objects of con­formity assessment except for conformity assessment bodies themselves, to which accreditation is applicable.
Conformity assessment: demonstration that specified requirements (3.1) relating to a product (3.3), process, system, person or body are fulfilled. The concept of “conformity assessment” is concerned with “fulfilment of specified requirements”. In English, the term “compliance” is used to distinguish the action of doing what is required (e.g. an organization “complies” by making something conform or by fulfilling a regulatory requirement).
Declaration: first-party attestation.
Designation: governmental authorization of a conformity assess­ment body to perform specified conformity assessment activities.
Equal and national treatment: treatment accorded to products or processes originating in other countries that is no less favour­able than that accorded to like products or processes of national origin, or originating in any other country, in a comparable situation.
Equivalence: equivalence of conformity assessment results; sufficiency of different conformity assessment results to provide the same level of assurance of conformity with regard to the same specified requirements.
First-party conformity assessment activity: conformity assessment activity that is performed by the person or organization that provides the object. The first-, second- and third-party descriptors used to characterize conformity assessment activities with respect to a given object are not to be confused with the legal identification of the relevant parties to a contract.
Inspection: examination of a product design, product, process or installation and determination of its con­formity with specific requirements or, on the basis of professional judgement, with general requirements. Inspection of a process may include inspection of persons, facilities, technology and methodology.
Member of a system or scheme: body that operates under the applicable rules and has the opportunity to take part in the management of the system or scheme.
Multilateral arrangement: arrangement whereby more than two parties recog­nize or accept one another's conformity assessment results.
Participant in a system or scheme: body that operates under the applicable rules without having the opportunity to take part in the management of the system or scheme.
Peer assessment: assessment of a body against specified requirements by representatives of other bodies in, or candidates for, an agreement group.
Procedure: specified way to carry out an activity or a process.
Product: result of a process. The ISO 9000 definition of “product” includes services as a product category, so that it is no longer correct to refer to “products and services”.
Recognition: recognition of conformity assessment results; acknowledgement of the validity of a conformity assessment result provided by another person or body.
Review: verification of the suitability, adequacy and effective­ness of selection and determination activities, and the results of these activities, with regard to fulfilment of specified requirements by an object of conformity assessment.
Sampling: provision of a sample of the object of conformity assessment, according to a procedure.
Second-party conformity assessment activity: conformity assessment activity that is performed by a person or organization that has a user interest in the object. Persons or organizations performing second-party conformity assessment activities include, for example, purchasers or users of products, or potential customers seeking to rely on a supplier's management system, or organizations representing those interests.
Specified requirement: need or expectation that is stated. Specified requirements may be stated in normative documents such as regulations, standards and technical specifications.
Surveillance: systematic iteration of conformity assessment activi­ties as a basis for maintaining the validity of the statement of conformity.
Testing: determination of one or more characteristics of an object of conformity assessment, according to a procedure.
Third-party conformity assessment activity: conformity assessment activity that is performed by a person or body that is independent of the person or organization that provides the object, and of user interests in that object.


ISO/IEC Guide 99:2007(en): International vocabulary of metrology — Basic and general concepts and associated terms
In general, a vocabulary is a “terminological dictionary which contains designations and definitions from one or more specific subject fields”. The present Vocabulary pertains to metrology, the “science of measurement and its application”. It also covers the basic principles governing quantities and units.
This Vocabulary is meant to be a common reference for scientists and engineers — including physicists, chemists, medical scientists — as well as for both teachers and practitioners involved in planning or performing measurements, irrespective of the level of measurement uncertainty and irrespective of the field of application. It is also meant to be a reference for governmental and inter-governmental bodies, trade associations, accredi­tation bodies, regulators, and professional societies.
The objective of measurement in the Error Approach is to determine an estimate of the true value that is as close as possible to that single true value. The deviation from the true value is composed of random and systematic errors. The two kinds of errors, assumed to be always distinguishable, have to be treated differently. No rule can be derived on how they combine to form the total error of any given measurement result, usually taken as the estimate. Usually, only an upper limit of the absolute value of the total error is estimated, sometimes loosely named “uncertainty”.
It is suggested that the components of measurement uncertainty should be grouped into two categories, Type A and Type B, according to whether they were evaluated by statistical methods or otherwise, and that they be combined to yield a variance according to the rules of mathematical probability theory by also treating the Type B components in terms of variances. The resulting standard deviation is an expression of a measurement uncertainty.
The objective of measurement in the Uncertainty Approach is not to determine a true value as closely as possible. Rather, it is assumed that the information from measurement only permits assignment of an interval of reasonable values to the measurand, based on the assumption that no mistakes have been made in performing the measurement. Additional relevant information may reduce the range of the interval of values that can reasonably be attributed to the measurand. However, even the most refined measurement cannot reduce the interval to a single value because of the finite amount of detail in the definition of a measurand. The definitional uncertainty, therefore, sets a minimum limit to any measurement uncertainty. The interval can be represented by one of its values, called a “measured quantity value”.
In some definitions, the use of non-defined concepts (also called “primitives”) is unavoidable. In this Vocabulary, such non-defined concepts include: system, component, phenomenon, body, substance, property, reference, experiment, examination, magnitude, material, device, and signal.