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<p>ISO/IEC 17043:2023 clause 6.1.3: <i>“When the PT item … meets the definition of ‘reference material,’ it shall be produced under conditions that meet the relevant requirements of ISO 17034.”</i> A large majority of Proficiency Test (PT) items are “materials …that are sufficiently homogeneous and stable with respect to one or more specified properties,” and the PT provider has established them “as fit for its intended use” (i.e. …as a PT item). Therefore, this requirement will apply across a very wide variety of PT schemes and test materials. How is this to be addressed by providers and accreditation bodies? The relevant requirements will vary depending on the PT material and the production activities that could affect the validity of PT activities. The main impact of this change is that accreditation bodies will need policies on what requirements are relevant, and whether other ISO/TC 334 standards should also be considered as normative, such as ISO 33406 on reference materials with qualitative properties. A second impact is that PTPs may be able to purchase RMs from accredited producers, rather than take on the cost and risk of making their own. A third potential benefit is a better understanding in the laboratory community of what reference materials are, and how they can be used. This could be new to some areas of testing where PT is being applied, but where RMs are not commonly available. Emerging areas of testing will require close harmony between PT providers and RM producers to ensure reliability.</p>

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The impact of making ISO 17034 normative for ISO/IEC 17043

  • 期刊论文

  • 发表日期：

    2026年3月28日

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  • Daniel Tholen,
  • Kelly Black

摘要

ISO/IEC 17043:2023 clause 6.1.3: “When the PT item … meets the definition of ‘reference material,’ it shall be produced under conditions that meet the relevant requirements of ISO 17034.” A large majority of Proficiency Test (PT) items are “materials …that are sufficiently homogeneous and stable with respect to one or more specified properties,” and the PT provider has established them “as fit for its intended use” (i.e. …as a PT item). Therefore, this requirement will apply across a very wide variety of PT schemes and test materials. How is this to be addressed by providers and accreditation bodies? The relevant requirements will vary depending on the PT material and the production activities that could affect the validity of PT activities. The main impact of this change is that accreditation bodies will need policies on what requirements are relevant, and whether other ISO/TC 334 standards should also be considered as normative, such as ISO 33406 on reference materials with qualitative properties. A second impact is that PTPs may be able to purchase RMs from accredited producers, rather than take on the cost and risk of making their own. A third potential benefit is a better understanding in the laboratory community of what reference materials are, and how they can be used. This could be new to some areas of testing where PT is being applied, but where RMs are not commonly available. Emerging areas of testing will require close harmony between PT providers and RM producers to ensure reliability.