ISO/REMCO, the Committee on Reference Materials of the International Organisation for Standardisation, has revised ISO Guide 33. In doing so, the document now provides a more comprehensive coverage of the mainstream applications of reference materials (RMs) and certified reference materials (CRMs). Unlike its predecessor, the new ISO Guide 33 now also covers calibration as one of the uses and aspects of preparing calibration RMs from pure materials, as done in many testing laboratories. These aspects were felt to be missing in guidance to laboratories. The Guide is now well aligned with the Guide to the Expression of Uncertainty in Measurement and its supplements. Many applications of RMs and CRMs in particular require the evaluation of measurement uncertainty or have an impact on it. Last but not least, the Guide also contains a specific clause dealing with the various aspects of selecting an RM for a particular purpose.

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... The use of reference materials (RMs) is a key activity for the improvement and maintenance of a worldwide coherent measurement system. As detailed in ISO Guide 33 [1], RMs with different characteristics are used in measurement processes, for the purpose of precision control, bias assessment, calibration, assigning values to other materials, and maintaining conventional scales, to name a few. This validation of methodology, evaluation, and calibration of associated instrumentation is often referred to as 'qualification' of a given system, particularly in the pharmaceutical industry. ...

  • Takeshi Saito
  • Angelique Botha Angelique Botha

The use of reference materials (RMs) is a key activity for the improvement and maintenance of a worldwide coherent measurement system. As detailed in ISO Guide 33, RMs with different characteristics are used in measurement processes, for the purpose of precision control, bias assessment, calibration, assigning values to other materials, and maintaining conventional scales, to name a few. For the establishment of metrological traceability of measurement results to international scales or other measurement standards, proper use of certified reference materials (CRMs) is essential. From the perspective of a reference material producer, the documentation that is provided with an RM is the value-adding component of the material; for the user, the document is critical for the correct implementation and use of the RM in the measurement process. The ISO Committee on Reference Materials (ISO/REMCO) recognised the importance of the documentation that accompanies a reference material as early as 1981 when the first edition of ISO Guide 31 was published. The third edition of the Guide that was published recently considers the appropriate accompanying documentation for all types of reference materials, i.e. CRMs and non-certified RMs.

... They are cornerstones to trace the result of an individual laboratory with an SI unit or another suitable reference measurement system. Though the production of certified reference materials (CRMs) is very complex especially for matrix CRMs such as soils, foods, other environmental samples, such materials are of high value [1,2] in quality assurance and quality control activities. The soil elements content along with other properties are important for determination of soil quality and are used to assess soil health and suitability for cultivation of crops. ...

Reference materials (RMs) are an indispensable part of QA/QC system and have played a critical role in the continual expansion of analytical capabilities of the analytical laboratories. The homogeneity study of the candidate for reference material is essential for the quality of reference material (certified reference material) used in quality assurance activities. The homogeneity study of candidate for reference materials of contaminated soil collected from a plot situated near the chemical factory "Rokita" in Brzeg Dolny (Silesian Region of Poland) for total metal content of Mg, Fe, Zn, Hg and analytes from a group of polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs) was carried out. The experimental design and study by using one way ANOVA showed no significant difference within and between bottle homogeneity and the material was found homogeneous. Total expanded uncertainty (k = 2) due to heterogeneity for all four metals and analytes from a group of PCBs and PAHs was determined within the range of 5–15%. The candidate for reference material of fortified soil was found to be homogeneous up to the minimum sample size of 100 mg for total Hg, 500 mg for Mg, Fe, Zn and 1 g from a group of PCBs and PAHs, and thus is suitable for certification.

Bharatiya Nirdeshak Dravya (BND®) is the trademark of Certified Reference Material (CRM) of CSIR-NPL. BNDs are the primary standards, which ensure reliability and comparability of the measurements as a benchmark for the quality assurance achieved through international networking. Networking between the NMIs through bilateral cooperation, participation with international bodies/organization establishes wide-ranging recognition of BND in India. BND is the heart of India's scientific and industrial development by establishing quality control in measurements. A detailed discussion to overcome barriers in international trade and standardization of measurement with high metrological aspect has been emphasized. BNDs are produced by CSIR-NPL: (i) in-house and (ii) in association with Reference Material Producers (RMPs) across the country as per ISO 17034 standard. A detailed emphasis on production of BNDs are given in Chap. 19. The BNDs produced by CSIR-NPL in different sectors are uploaded in the international COMAR database, i.e. COde d'Indexation des Matériaux de Reference (COMAR) for its global visibility. To enhance the impact of reference materials in the global economy, Bureau of Indian Standard (BIS) has recently established national mirror committee on reference materials which is a part of ISO-REMCO (Committee on reference materials). The main aim of this chapter is to make the readers acquainted with process and guidelines who are working in reference standard and looking for certification of their products. This chapter describes the terminology/definition and international networking. The metrological traceability of BNDs established are linked to SI units which have been elaborated in detail. Further, the metrological perspective, such as testing, calibration, method of validation, repeatability, reproducibility studies, control chart preparation, inter-laboratory comparison, quality control and quality assurance are also discussed for a broader readership. A detailed emphasis has been given on international key comparison, proficiency/round-robin testing, pilot study in various sectors like physico-mechanical, physico-chemical, foods/feedstuffs, biomedical, environmental, health-care, agricultural etc. in this chapter.

We present new reference values for nineteen USGS, GSJ, and GIT-IWG rock reference materials that belong to the most accessed samples of the GeoReM database. The determination of the reference values and their uncertainties at the 95% confidence level follows as closely as possible ISO guidelines and the Certification Protocol of the International Association of Geoanalysts. We used analytical data obtained by state-of-the-art techniques published mainly in the last 20 years and available in GeoReM. The data are grouped into four categories of different levels of metrological confidence, starting with isotope dilution mass spectrometry as a primary method. Data quality was checked by careful investigation of analytical procedures and by the application of the Horwitz function. As a result, we assign a new and more reliable set of reference values and respective uncertainties for major, minor and a large group of trace elements of the nineteen investigated rock reference materials. This article is protected by copyright. All rights reserved.

Reference materials (RMs) are widely used in measurement laboratories for a variety of purposes, and it is important to recognise that the material most appropriate for a particular application should be used. Certified reference materials (CRMs) are used for method validation, the calibration of a measurement system and all other aspects of the evaluation of the measurement system where the trueness of the measurement result is required. For other aspects, such as quality control, precision studies, the checking of the variability between operators, where the results are compared relatively, any suitable reference material can be used. ISO/REMCO, the ISO Committee on Reference Materials, has prepared ISO Guide 80, a guidance document for the in-house preparation of quality control materials (QCMs). QCMs are mostly used to monitor the performance of laboratory methods that have already been validated over time to be able to detect change or when a method goes out of statistical control. QCMs are RMs and as such have to be sufficiently homogeneous and stable for the intended use. QCMs are usually prepared in-house by laboratory staff for in-house use only, and therefore, the requirements for "in-house" QCMs are less demanding than those for a CRM. For example, transport issues are not of concern. The quality assessment of QCMs should involve homogeneity and stability assessments, and a limited characterisation of the material to provide an indication of its relevant property values and their variation, prior to use.

The new definitions for reference material and certified reference material as approved by ISO REMCO are provided and further explained.

The use of reference materials (RMs) and the regular participation in proficiency testing (PT) schemes have become fundamental pillars of assuring and controlling the quality of analytical data in terms of precision and accuracy, thus proving the competence of analytical laboratories. In recent times, many terms describing non-certified reference materials (non-certified RMs) have emerged, often the result of confusing use with characteristics. Depending on the use of a material, a certain number of characteristics (e.g., homogeneity and assigned value) must be demonstrated. This article reviews the main types of application of RMs and describes the main material characteristics needed to fulfill the corresponding purposes. Based on this, it summarizes minimum requirements for certain uses.

  • Adriaan M. H. van der Veen Adriaan M. H. van der Veen

The use of (certified) reference materials and quality control materials can form a suitable basis for evaluating measurement uncertainty of routine measurements. In particular when these materials are used for quality control purposes, it is not always evident how the quality control data can be used in the uncertainty budget of a routine measurement. Current guidance documents on the evaluation of measurement uncertainty and the use of reference materials treat this subject only in part, or in very generic terms. ISO/REMCO has established a new working group that will provide practical guidance and examples on how to use quality control data in the evaluation of measurement uncertainty. A short introduction to the subject is given.

Guidelines for the selection and use of certified reference materials. International Laboratory Accreditation Cooperation (ILAC), Silverwater 22. Van der Veen AMH (2003) Measurement uncertainty and the use of reference materials

ILAC-G9 (1996) Guidelines for the selection and use of certified reference materials. International Laboratory Accreditation Cooperation (ILAC), Silverwater 22. Van der Veen AMH (2003) Measurement uncertainty and the use of reference materials. Accred Qual Assur 8:555–558

Calibration in analytical chemistry and use of certified reference materials International Organization for Standardization, Geneva 4. ISO Guide 33 (2015) Reference materials—good practice in using reference materials

ISO Guide 32 (1997) Calibration in analytical chemistry and use of certified reference materials, 1st edn. International Organization for Standardization, Geneva 4. ISO Guide 33 (2015) Reference materials—good practice in using reference materials, 3rd edn. International Organization for Standardization, Geneva

Accuracy (trueness and precision) of measurement methods and results. International Organization for Standardization

ISO 5725 (1994) Accuracy (trueness and precision) of measurement methods and results. International Organization for Standardization, Geneva

International Organization for Standardization, Geneva 14. ISO 15189 (2012) Medical laboratories-requirements for quality and competence

ISO/IEC 17025 (2005) General requirements for the competence of testing and calibration laboratories, 2nd edn. International Organization for Standardization, Geneva 14. ISO 15189 (2012) Medical laboratories-requirements for quality and competence. International Organization for Standardization, Geneva

International Organization for Standardization, Geneva 8 http:// www.bipm.org/en/cipm-mra/ 9 Uses of certified reference materials Guide to the expression of uncertainty in measurement

ISO Guide 80 (2014) Guidance for the in-house preparation of quality control materials (QCMs). International Organization for Standardization, Geneva 8. CIPM Mutual Recognition Arrangement (CIPM MRA), http:// www.bipm.org/en/cipm-mra/ 9. ISO Guide 33 (2000) Uses of certified reference materials, 2nd edn. International Organization for Standardization, Geneva 10. BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (2008) Guide to the expression of uncertainty in measurement. JCGM 100, GUM:1995 with minor corrections, BIPM, Sèvres 11. BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (2008) Supplement 1 to the 'Guide to the expression of uncertainty in measurement'—propagation of distributions using a Monte Carlo method. JCGM 101

Reference materials—Selected terms and definitions

  • Guide

Reference materials—contents of certificates and labels

  • ISO Guide

Medical laboratories—requirements for quality and competence. International Organization for Standardization

  • ISO

Reference materials-Selected terms and definitions, 3rd edn. International Organization for Standardization

ISO Guide 30 (2015) Reference materials-Selected terms and definitions, 3rd edn. International Organization for Standardization, Geneva

Reference materials-contents of certificates and labels, 2nd edn. International Organization for Standardization

ISO Guide 31 (2000) Reference materials-contents of certificates and labels, 2nd edn. International Organization for Standardization, Geneva

Calibration in analytical chemistry and use of certified reference materials, 1st edn. International Organization for Standardization

ISO Guide 32 (1997) Calibration in analytical chemistry and use of certified reference materials, 1st edn. International Organization for Standardization, Geneva

Reference materials-good practice in using reference materials, 3rd edn. International Organization for Standardization

ISO Guide 33 (2015) Reference materials-good practice in using reference materials, 3rd edn. International Organization for Standardization, Geneva

General requirements for the competence of reference material producers, 3rd edn. International Organization for Standardization

ISO Guide 34 (2009) General requirements for the competence of reference material producers, 3rd edn. International Organization for Standardization, Geneva

Reference materials-general and statistical principles for certification, 3rd edn. International Organization for Standardization

ISO Guide 35 (2006) Reference materials-general and statistical principles for certification, 3rd edn. International Organization for Standardization, Geneva

Guidance for the in-house preparation of quality control materials (QCMs). International Organization for Standardization

ISO Guide 80 (2014) Guidance for the in-house preparation of quality control materials (QCMs). International Organization for Standardization, Geneva

International Organization for Standardization, Geneva 10

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ISO Guide 33 (2000) Uses of certified reference materials, 2nd edn. International Organization for Standardization, Geneva 10. BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (2008) Guide to the expression of uncertainty in measurement. JCGM 100, GUM:1995 with minor corrections, BIPM, Sèvres

Supplement 2 to the 'Guide to the expression of uncertainty in measurement'-extension to any number of output quantities

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BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP, OIML (2011) Supplement 2 to the 'Guide to the expression of uncertainty in measurement'-extension to any number of output quantities. JCGM 102, BIPM, Sèvres