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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(en) 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(en)

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


MitoPedia concepts: "MitoFit Quality Control System" is not in the list (MiP concept, Respiratory state, Respiratory control ratio, SUIT concept, SUIT protocol, SUIT A, SUIT B, SUIT C, SUIT state, Recommended, ...) of allowed values for the "MitoPedia concept" property. MitoFit Quality Control System"MitoFit Quality Control System" is not in the list (Enzyme, Medium, Inhibitor, Substrate and metabolite, Uncoupler, Sample preparation, Permeabilization agent, EAGLE, MitoGlobal Organizations, MitoGlobal Centres, ...) of allowed values for the "MitoPedia topic" property. 






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.