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.     

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.     

Purity assessment using the mass balance approach for inorganic in-house certified reference material production at Inmetro

Accreditation and Quality Assurance - The production of Certified Reference Materials (CRMs) is one of the essential activities of the National Institute of Metrology, Quality and Technology...     

Guidance on the contents of accompanying documentation for reference materials (RMs)

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.     

Double molecular imprinting--a new sensor concept for improving selectivity in the detection of polycyclic aromatic hydrocarbons (PAHs) in water

It is now well recognised that the quality control (QC) of all types of analyses, including environmental analyses depends on the appropriate use of reference materials. One of the ways to check the accuracy of methods is based on the use of Certified Reference Materials (CRMs), whereas other types of (not certified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g. proficiency testing). The perception of these materials, in particular with respect to their production and use, differs widely according to various perspectives (e.g. RM producers, routine laboratories, researchers). This review discusses some critical aspects of RM use and production for the QC of environmental analyses and describes the new approach followed by the Measurements & Testing Generic Activity (European Commission) to tackle new research and production needs.     

Outline for the revision of ISO Guide 35

The production 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 measurements, such as calibration, quality control and method validation, as well as for the assignment of values to other materials. Currently, ISO Guide 35 is in its third edition after it was revised in 2006. The Guide was developed to support best practices in the value assignment to specified properties of Certified Reference Materials (CRMs). This Guide gives general guidance and explains concepts to assist the understanding and development of valid methods to assign values to the properties of a reference material, including the evaluation of their associated measurement uncertainties, and the establishment of their metrological traceability. From the outcome of a systematic review of ISO Guide 35 among the members of ISO/REMCO, the ISO Committee on Reference Materials, it followed that there is a need for revising the current edition of ISO Guide 35. The mandate for the revision is focused on editorial updates to explain the concepts in more detail. It is not envisaged that major technical changes will be introduced. This paper explains the approach and rationale for the revision of ISO Guide 35 and invites comments from the users of the current edition of ISO Guide 35.     

Double molecular imprinting – a new sensor concept for improving selectivity in the detection of polycyclic aromatic hydrocarbons (PAHs) in water

It is now well recognised that the quality control (QC) of all types of analyses, including environmental analyses depends on the appropriate use of reference materials. One of the ways to check the accuracy of methods is based on the use of Certified Reference Materials (CRMs), whereas other types of (not certified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g. proficiency testing). The perception of these materials, in particular with respect to their production and use, differs widely according to various perspectives (e.g. RM producers, routine laboratories, researchers). This review discusses some critical aspects of RM use and production for the QC of environmental analyses and describes the new approach followed by the Measurements & Testing Generic Activity (European Commission) to tackle new research and production needs.     

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.     

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.     

The Operational System of National Accreditation of Laboratories in China

This document gives a brief introduction to CNACL (China National Accreditation Committee for Laboratories). Laboratory accreditation in China is integrally administrated by the China State Bureau of Quality and Technical Supervision, a government administrative department of China State Council, which authorizes CNACL to implement Chinese laboratory accreditation activities. CNACL was established on September 20, 1994. It is a full member of both ILAC (International Laboratory Accreditation Cooperation), and APLAC (Asia Pacific laboratory Accreditation Cooperation), and signed the APLAC MRA (Mutual Recognition Arrangement) in New Delhi, India on December 3, 1999. CNACL carries out laboratory accreditation activities in full compliance with international general criteria. Its operation complies with ISO/IEC Guide 58 (1993), ISO/IEC 17025 (1999), ISO/IEC Guide 43 (1997) and other international standards.     

Characterization (certification) of Bovine Muscle Powder (NIST RM 8414), Whole Egg Powder (NIST RM 8415) and Whole Milk powder (NIST RM 8435) Reference Materials for essential and toxic major, minor and trace element constituents

Summary Bovine Muscle Powder (NIST RM 8414), Whole Egg Powder (NIST RM 8415) and Whole Milk Powder (NIST RM 8435) Reference Materials were characterized for essential and toxic major, minor and trace element composition in an interlaboratory cooperative characterization campaign. Extensive application of widely varied analytical methods yielded best estimate concentration values for 27, 23 and 21 elements, and informational concentration values for 5, 4 and 9 elements, respectively, in RM's 8414, 8415 and 8435. These Reference Materials are intended for analytical quality control of element determinations on meat, egg and milk-based products as well as agricultural/food materials with related matrices.Contribution no. 92–147 from Centre for Land and Biological Resources Research     

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.     

Biological Reference Materials for Quality Control of Elemental Composition Analytical Data

Twelve biological-matrix, agricultural/food reference materials, Corn Stalk (Zea Mays) (NIST RM 8412), Corn Kernel (Zea Mays) (NIST RM 8413), Bovine Musele Powder (NIST RM 8414), Whole Egg Powder (NIST RM 8415), Microcrystalline Cellulose (NIST RM 8416), Wheat Gluten (NIST RM 8418), Corn Starch (NIST RM 8432), Corn Bran (NIST RM 8433), Whole Milk Powder (NIST RM 8435), Durum Wheat Flour (NIST RM 8436), Hard Red Spring Wheat Flour (NIST RM 8437) and Soft Winter Wheat Flour (NIST RM 8438) were developed. They were characterized with respect to elemental composition via two extensive international interlaboratory characterization campaigns providing 303 reference and informational concentration values for 34 elements (Al, As, B, Ba, Br, Ca, Cd, Cl, Co, Cr, Cs, Cu, F, Fe, Hg, I, K, Mg, Mn, Mo, N, Na, Ni, P, Pb, Rb, S, Sb, Se, Sr, Ti, V, W, Zn) of nutritional, toxicological, and environmental significance. These products are available to the analytical community, for quality control of elemental composition analytical data, from the Standard Reference Materials Program, National Institute of Standards and Technology, Gaithersburg, MD, USA.     

Drugs and related topics

Drugs is a topic that was certainly an issue of discussion at this year's annual meeting. This Committee had the responsibility of organizing a half day symposium on "Pharmaceutical Authenticity and Safety" that took place September 12, 2005. This symposium aims at improving the critical points in the analytical pharmaceutical field related to traceability assessment, use of certified reference materials (CRMs), and proficiency testing implementation to get the highest quality of the obtained results. Recognized experts presented these topics. Also, other complementary subjects, such as the application of advanced analytical technologies to reach the authenticity and safety of the pharmaceutical drugs and drug products, their microbiological quality assessment, without disregarding an important topic such as sampling, was presented and discussed. The talks that were presented are the following: "Proficiency Testing as a Need in the Pharmaceutical Field," Arlene Fox (AOAC INTERNATIONAL, Gaithersburg, MD); "Implementation of Traceability in the Pharmaceutical Laboratory," Thomas Layloff, (Management Sciences for Health, Arlington, VA); "Harmonized Characteristics of Certified Reference Materials According to ISO Guides-Attractive also for Pharmaceutical Analysis," Hendrik Emons (Reference Materials, Unit Institute for Reference Materials and Measurements (IRMM), Joint Research Centre European Commission, (Geel, Belgium); "Importance of LC/MS/MS for the Fingerprinting of Pharmaceutical Drugs," Paul A. Steinberg, (Thermo Electron Corp., Woodstock, GA); "Process Analytical Technology (PAT) as a Way for Better Manufacturing and Quality Assurance," John F. Kauffman (Division of Pharmaceutical Analysis, U.S. Food and Drug Administration (St. Louis, MO); "Stability Testing for the Safety Assessment of Pharmaceuticals," Marta Vidal (Boeringher Ingelheim Argentina, Buenos Aires, Argentina); "Validation of Microbiological Methods for Sterile and Nonsterile Pharmaceutical Products," Michael Brodsky (Brodsky Consultants, Thornhill, ON, Canada); "The Relationship Between Pharmacopoeial Reference Standards and ISO REMCO Initiatives and Guides," Ronald G. Manning (United States Pharmacopoeia, Rockville, MD).     

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.     

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.     

Matching reference materials with AOAC International methods of analysis

Proper implementation and use of validated analytical methodology with use of appropriate reference materials (RM) is a preferred means of helping to ensure equivalent analytical method performance in diverse laboratories. Choice of an appropriate RM that not only matches the analyte and matrix of the required determination, but also has been demonstrated to be within the applicability of a specific analytical method, are key factors. In response to numerous requests since its founding in 1993, the Technical Division on Reference Materials (TDRM), AOAC International is implementing a program for recognizing the matching of specific reference materials to specific AOAC methods of analysis. This recognition is accomplished by means of a thorough peer-reviewed selection system, under the auspices of the AOAC official methods board and the executive committee of the TDRM. Potential RM/method matching (RM/MM) proposals will be submitted to an RM/MM committee. After technical review of the suitability of the proposed RM by the RM/MM committee, acceptable matches are recommended for review by the current AOAC process responsible for review and recognition of new methods and modifications to existing AOAC methods of analysis. Several trial matches have been used to develop and test this system. The end product of this effort will ultimately be made available as either a stand-alone document, a section of the AOAC Official Methods of Analysis, or a site within the AOAC web site listing recognized matches.     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

Characterization (certification) of three wheat flours and a wheat gluten reference material (NIST RM 8436, 8437, 8438 and 8418) for essential and toxic major, minor and trace element constituents

Summary Three wheat flours, Durum Wheat Flour (NIST RM 8436), Hard Red Spring Wheat Flour (NIST RM 8437), Soft Winter Wheat Flour (NIST RM 8438) and Wheat Gluten (NIST RM 8418) Reference Materials were characterized for essential and toxic major, minor and trace elemental composition by analysts in an interlaboratory cooperative characterization campaign. Extensive application of widely varied analytical methods yielded 16–27 best estimate and 3–8 informational concentration values for each of these materials. These reference materials are intended for analytical quality control of element determinations in flour and flour products as well as other agricultural/food materials with related matrices.Contribution No. 92–145 from Centre for Land and Biological Resources Research     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998