Accreditation of reference material producers: Let's get it right!

The accreditation of testing and calibration laboratories to ISO/IEC 17025 is increasingly calling for the accreditation of reference material (RM) producers. Two international guides, ISO Guide 34 (2000) " General requirements for the competence of reference material producers" issued by the ISO Committee on Reference Materials and ILAC-G 12 " Guidelines for the requirements for the competence of reference material producers" issued by the International Laboratory Accreditation Cooperation (ILAC), are already in use for this purpose. Recently however initiatives have been launched to accredit RM producers to ISO 17025 as calibration laboratories and it has been suggested that a combination of ISO/IEC 17025 " General requirements for the competence of testing and calibration laboratories" and ISO Guide 34 may be the best option. This publication is an expression of the position of the ISO Committee on Reference Materials (ISO/REMCO) on the standards and guides currently in use in the accreditation of RM producers. The paper discusses the advantages and disadvantages of these standards and guides from the perspective of benefit to RM producers and RM users. In conclusion, the use of ISO Guide 34 alone or in combination with ILAC-G 12 is the preferred system for the accreditation of RM producers. Therefore ISO/REMCO strongly encourages all accreditation bodies to adopt ISO Guide 34.     

Accreditation system for reference material producers and certified reference materials for iron and steel in Japan

  ISO 9000 series strictly requires traceability to national or international measurement standards. It is becoming more necessary to make clear the concept of traceability of measurement standards with respect to chemical composition and to accredit the reference material producers. In Japan, the accreditation system for reference material producers is considered to satisfy the requirement of ISO Guide 34, ISO 9000 series and ISO/IEC Guide 25, while the producer fulfills the concept of traceability of measurement standards. This paper describes the production of iron and steel reference materials in Japan relating to the international standardization of methods (written standards) and accreditation of reference material producers. Received: 11 October 1996 Accepted: 5 December 1996     

The third edition of ISO Guide 34: what were the drivers for the revision and what is new?

After the International Laboratory Accreditation Cooperation (ILAC) had taken in 2004, the resolution to conduct accreditation of producers of reference materials according to ISO Guide 34 ‘General requirements for the competence of reference material producers’ in combination with ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’, ISO/REMCO, the ISO Committee on Reference Materials, decided in 2005 to revise ISO Guide 34 to align it closer with ISO/IEC 17025 and to clarify certain issues for accreditors and producers seeking accreditation without adding new requirements. Moreover, the publication in 2007 of ISO/IEC Guide 99 ‘International vocabulary of metrology—Basic and general concepts and associated terms (VIM)’ triggered additional adaptations of the guide.     

New ISO Guide 34 – How is the change affecting practice in the Czech Republic?

 The positive contribution of the ISO Guide 34 review is the idea of increasing responsibility of reference materials producers. The change of the main intention introduces some problems related to national legislation. There is a very important discussion going on about these problems among metrological bodies, accreditation institutes, reference material producers and laboratories.     

Implementation of ISO Guide 34: Accreditation for reference material production

The National Analytical Reference Laboratory of the Australian Government Analytical Laboratories was initially accredited to ILAC Guide G 12:2000 in January 2000 and is currently accredited to ISO Guide 34 (2000) for the production of a range of pure organic substance reference materials. This paper discusses the practical challenges and rewards of developing and implementing a quality system for reference material production and discusses some of the barriers, and potential solutions, to more general implementation of third-party accreditation.     

Certification of reference materials and accreditation of reference material producers: Questionable terminology leads to confusion

In the view of the Deutscher Kalibrierdienst (DKD) , a certifying body for reference materials can be considered to be a calibration laboratory. Therefore, accreditation of calibration laboratories in accordance with ISO/IEC 17025 is the most appropriate way to establish confidence in certificates for reference materials. If necessary, the criteria of ISO/IEC 17025 can be tailored to specific cases. There is no need to provide any new kind of reference-material specific accreditation. However, in view of the variety of reference materials and the practice existing in other countries, accreditation of testing laboratories and product certification bodies may optionally be acceptable as long as the same stringent principles with respect to traceability and measurement uncertainty are applied. Such accreditations but not accreditations of reference material producers (ISO Guide 34) are also covered by existing international mutual recognition arrangements (MRA).     

Laboratory accreditation in Italy for reference solution production of sucrose in water

The accreditation of Chemifarm srl laboratory for the calibration of two characteristics on the same aqueous solution has been achieved. The process has been executed by the Italian accreditation body for calibration laboratories (SIT). This is the first example of a producer of certified reference solutions in Italy. The solutions are mixtures of sucrose in water at several concentrations and are characterised for refractive index in the range of 1.33299 to 1.38115 and for mass fraction of sucrose in the range of 0 to 30 (commercially expressed in Brix degrees). Both traceability paths, obtained through refractometric and gravimetric methods, are reported. Furthermore, the paper describes the approach adopted to match the criteria based on ISO Guide 34 and ILAC-G 12, the documents with requirements for certified reference material producers, in compliance with those of ISO/IEC 17025, the norm for the laboratory accreditation.     

Accreditation of reference material producers: the example of IRMM's Reference Materials Unit

The potential approaches for third-party assessment of reference material producers are revisited and the activities of the Reference Materials (RM) Unit of the Institute for Reference Materials and Measurements (IRMM) to obtain accreditation to ISO Guide 34 and ISO 17025 are described. Accreditation was related to the Unit as all matrix RM activities of the institute are concentrated there. A management system was established that allows sufficient flexibility to be applicable to a wide range of RMs while being precise enough to ensure compliance with ISO Guides 30, 31 and especially 34 and 35. Accreditation was achieved in 2004 with independent scopes for testing and RM production and was confirmed and extended in 2005. The key aspects of the RM Unit's management system for RM production are presented. Presented at BERM-10, April 2006, Charleston, SC, USA     

The work of ISO-REMCO’s accreditation task group

This paper discusses some of the work of ISO-REMCO’s Task Group 4 (TG4) – the Accreditation TG, giving firstly a brief account of the recently published ISO Guide 34 – which gives guidance on the type of quality system a reference material producer should have in place. Secondly, work on the future development of Guide 34 to produce a document against which it will be possible for producers to be accredited without reference to ISO Guide 25 is discussed, and thirdly, the possible formation of an international register of CRM producers, which will provide users with information about the quality status of different producers, is considered.     

The view of IRMM on accreditation of CRM producers

This article describes the views of IRMM on accreditation of CRM producers and the philosophy which is behind these views. More specifically, it explains the reasons for choosing ISO Guide 34 rather than ISO/IEC 17025 as the basis document for the proposed accreditation of its CRM activites. Received: 27 May 2002 Accepted: 11 July 2002 Acknowledgements Information on accreditation programmes in Australia and USA provided by Maree Stuart (NATA) and Randall V. Querry (AL2A) is greatly acknowledged. Correspondence to J. Pauwels     

The external review committee on pure reference materials at the National Analytical Reference Laboratory

The preceding paper described the implementation of a quality assurance system suitable for accreditation to ISO Guide 34 by the Pure Substance Reference Material (PSRM) team of the National Analytical Reference Laboratory (NARL). One of the key components of this system has been the establishment of an external advisory committee that scrutinises each candidate material that is to be offered as a reference material. At the time of writing 190 reference materials were available from NARL, including a range of illicit drugs and agricultural chemicals in addition to anabolic steroids and their metabolites, and all have been reviewed by the external committee prior to final approval by the accredited production signatory.     

Accreditation of reference material producers

 The use of reference materials is the most pragmatic means by which the analyst can achieve comparability of data. Reference material producers therefore need to have adequate quality systems in place for ensuring the reliability of their materials. In order to provide guidance to both producers and assessors, ISO Guide 34 has recently been produced detailing the quality system requirements for the production of reference materials. CITAC, REMCO and ILAC are now collaborating in the revision of this guide to produce a free-standing document detailing the general requirements for the competence of reference material producers. This paper discusses some of the more important issues described in these documents. The possible formation of an international register containing details of a reference material producer's quality system status is also discussed.     

Development of a standard for the organization of the interlaboratory comparisons in microbiology of food

The ILAC G13 Guide and the ISO IEC Guide 43-1 are the common, general and horizontal bases for accreditation of providers of proficiency testing and interlaboratory comparisons used by several accreditation bodies. Despite their widespread use, these guides omit specific technical requirements, and sometimes even elements of quality management, clearly defined for the organization of proficiency-testing schemes for microbiology of food. The Sub-Committee 9 “Microbiology of food” of ISO TC34 has created a working group (WG4) to establish a standard detailing such specific requirements for microbiology of food. This technical standard will describe those specific requirements of proficiency testing which organizers of proficiency-testing schemes and any subcontractors must satisfy in addition to the requirements of the ILAC G13 Guide and the ISO IEC Guide 43-1 to achieve accreditation or other recognition.     

Use of ISO Guides 25, 30, 31, 34, 35, and 9001 in re-engineering Bethlehem Steel Corporation's analytical chemistry reference materials program

 Many certified reference materials are needed to calibrate and control analytical measurement processes in integrated steel works. It is beyond the scope and capacity of most national laboratories to supply all of these needs. Yet, the demand for these materials is steadily increasing as more steel producers update their quality systems in preparation for ISO 9000 registration and/or ISO Guide 25 laboratory accreditation assessments. This paper describes how the Bethlehem Steel Corporation updated its reference materials program to meet its internal needs and offers a model for use by others in improving their programs. Received: 22 April 1998 · Accepted: 12 May 1998     

对新版ISO导则34的理解

标准物质在实现测量结果溯源性以及不同时空测量结果的可比性方面具有广泛的应用。面对标准物质需求的不断增长和标准物质生产者数量的不断增加,新版ISO导则34：2009《标准物质生产者能力的通用要求》于2009年发布,以在促进该领域研究发展的同时,确保各种不同来源标准物质的质量。针对新版ISO导则34所涉及的相关名词术语以及一些重要原则进行了讨论,以促进对该导则的理解和在我国的推广应用。     

Estimating the uncertainty of stability for matrix CRMs

The new version of ISO Guide 34 requires producers of certified reference materials (CRMs) to include contributions of possible instability to the overall CRM uncertainty, to obtain a value for the uncertainty in compliance with the Guide to the Expression of the Uncertainty in Measurement (GUM). A pragmatic approach to estimating the uncertainty of stability is presented. It relies on regression analysis of stability data with subsequent testing of the slope of the regression line for significance. If the slope is found to be statistically insignificant, a shelf life is chosen and the uncertainty connected with this time is estimated via the standard deviation of the slope. This uncertainty is included in the overall uncertainty of the CRM. This approach is explained with examples showing its applicability to matrix CRMs. Received: 12 October 2000 / Revised: 2 January 2001 / Accepted: 3 January 2001     

k0-NAA, a valuable tool for reference-material producers.

The main concern of producers of certified reference materials (CRM) is the preparation of high-quality products with demonstrated homogeneity and stability, combined with a well established set of certified characteristics. CRM producers must, furthermore, comply with other constraints imposed by the ISO Guide 34: production processes, production control, and certification analyses should be performed by expert laboratories, using validated protocols documented in their respective quality assurance manuals; laboratory mean values and the corresponding "expanded" uncertainties, must be used for the determination of the certified values, as recommended by the ISO Guide to the Expression of Uncertainties in Measurements (GUM); and when possible, traceability of the certified value to the SI units, using appropriately validated and/or primary methods, must be ensured. k0-NAA, i.e. neutron activation analysis with k0 standardization, is one of the analytical techniques implemented at the Reference Material Unit of IRMM; it meets the first two requirements.     

Implementing the GUM in the certification of reference materials: the revision of ISO Guide 35

The availability of certified reference materials, certified in accordance to the GUM is an important tool for the proper estimation of measurement uncertainty in routine analysis. Many CRMs may suffer from incomplete or wrongly estimated uncertainties, mainly due to lack of guidance on how to implement the GUM in the production of CRMs. In particular the inclusion of the impact of inhomogeneity and instability in the uncertainty budget is often missing. The ongoing revision of ISO Guide 35 aims to fill this gap in providing guidance how (batch) inhomogeneity and instability can be translated into measurement uncertainty. The structure of the current ISO Guide 35 has been maintained as far as possible, but major parts underwent revision to become better aligned with GUM and ISO Guide 34 (2000). Received: 9 April 2001 Accepted: 22 October 2001     

k0-NAA, a valuable tool for reference-material producers

The main concern of producers of certified reference materials (CRM) is the preparation of high-quality products with demonstrated homogeneity and stability, combined with a well established set of certified characteristics. CRM producers must, furthermore, comply with other constraints imposed by the ISO Guide 34: ·*production processes, production control, and certification analyses should be performed by expert laboratories, using validated protocols documented in their respective quality assurance manuals; ·*laboratory mean values and the corresponding “expanded” uncertainties, must be used for the determination of the certified values, as recommended by the ISO Guide to the Expression of Uncertainties in Measurements (GUM); and ·*when possible, traceability of the certified value to the SI units, using appropriately validated and/or primary methods, must be ensured. k₀-NAA, i.e. neutron activation analysis with k₀ standardization, is one of the analytical techniques implemented at the Reference Material Unit of IRMM; it meets the first two requirements.     

Estimating the uncertainty of stability for matrix CRMs.

The new version of ISO Guide 34 requires producers of certified reference materials (CRMs) to include contributions of possible instability to the overall CRM uncertainty, to obtain a value for the uncertainty in compliance with the Guide to the Expression of the Uncertainty in Measurement (GUM). A pragmatic approach to estimating the uncertainty of stability is presented. It relies on regression analysis of stability data with subsequent testing of the slope of the regression line for significance. If the slope is found to be statistically insignificant, a shelf life is chosen and the uncertainty connected with this time is estimated via the standard deviation of the slope. This uncertainty is included in the overall uncertainty of the CRM. This approach is explained with examples showing its applicability to matrix CRMs.