ISO/IEC 17043: the new International Standard for proficiency testing

The revision of ISO/IEC Guide 43 is well underway by CASCO Working Group 28, with the author as Convener. The ballot on the committee draft was successfully completed in June 2008. The Working Group met in September to resolve the CD comments and to recommend that the document should advance as an ISO/IEC DIS. The document is in harmony with ISO/IEC 17025 (2005), ILAC G13 (2007), and the IUPAC Harmonized Protocol (2006) for proficiency testing. Major changes from Guide 43 include considerations for inspection bodies, requirements for metrological traceability of assigned values for calibration schemes, limitations on subcontracting, requirements for reporting the uncertainty of assigned values, and for including method information and technical commentary in scheme reports. Minor changes include requirements for equipment used in the manufacture and testing of proficiency test items, considerations for handling laboratories’ reported uncertainties, and the issuance of certificates of participation. These changes have not generated any substantial objections from the CASCO membership and liaisons.     

Accrediting PT/EQA providers to ISO/IEC 17043

After many years and having several different attempts for the accreditation of proficiency testing provider (PT provider), there is finally one stand-alone standard defining the requirements for the competence of PT providers and therefore an internationally harmonised basis for the accreditation of proficiency test providers. Since February 2010, the ISO/IEC 17043:2010 has replaced ISO/IEC Guide 43:1997 and ILAC G 13:2007. The philosophy of the standard about subcontracting work is different to this of the standards mostly used for accreditation like ISO/IEC 17025:2005 or ISO/IEC 17020:2004, etc. Besides the planning of the proficiency tests (PT), the performance evaluation and the authorisation of the PT reports the ISO/IEC 17043:2010 allows subcontracting for the rest of the work when providing PTs. This is a challenge for the assessors to judge about the competence of a PT provider. In numerous paragraphs, the standard sets very detailed requirements. Nevertheless, there is room for interpretation. For these cases, for example, contracts for subcontractors, procedure for the advisory board, minimum requirements for PT certificates, etc., some proposals are given to enable harmonised approach for the assessment of PT providers.     

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.     

Accreditation of proficiency-testing schemes in The Netherlands

Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.     

Experiences from the assessment of proficiency testing providers

Following a pilot project in 2001–2002, UKAS accredited nine PT providers. During the course of the pilot and at subsequent surveillance visits, UKAS has gained experience in assessing organisations against the criteria detailed within ISO/IEC Guide 43-1:1997 and ILAC G13:2000. This article explores some of the key aspects that arose during the pilot and how UKAS has accommodated the addition of the accreditation of PT providers in to its range of services.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia     

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 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.     

Performance of uncertainty evaluation strategies in a food proficiency scheme

A study of the performance of different uncertainty evaluation strategies among 163 voluntary respondents from food proficiency schemes is presented. Strategies included use of: single-laboratory validation data, quality control data, past proficiency testing data, reproducibility data, a measurement equation and the dispersion of replicate observations on the test material. Most performed reasonably well, but the dispersion of replicate observations underestimated uncertainty by a factor of approximately 3. Intended compliance with accreditation requirements was associated with significantly improved uncertainty evaluation performance, while intended compliance with the ISO “Guide to the expression of uncertainty in measurement” had no significant effect. Substituting estimates based on the Horwitz or Horwitz–Thompson models or on PT target standard deviation for the respondents’ own estimates of uncertainty led to a marked reduction in poor zeta scores and significant improvement in dispersion of zeta scores.     

The challenges and benefits of implementing the requirements of ISO/IEC 17043 by PT/EQA providers

ISO/IEC 17043 Conformity assessment??general requirements for proficiency testing is intended to replace previous international guides used to assess the competence of proficiency testing (PT) providers. It expands on the requirements of previous guides and is intended to accommodate PT providers of calibration laboratories and testing laboratories handling both qualitative and quantitative data. QMP-LS is an office-based external quality assessment provider for medical laboratories in Ontario, Canada and operates 46 different PT schemes for approximately 250 diagnostic tests. In 2010, these schemes were accredited to ISO/IEC 17043. Schemes included tests from the following disciplines: chemistry, hematology, microbiology, transfusion medicine, cytology, histology and genetics. Thirty of the schemes were qualitative. The challenges and benefits of implementing ISO/IEC 17043 are discussed, with particular emphasis on clauses addressing the following requirements: statistical design, determination of assigned value, homogeneity and stability testing, packaging, labeling and distribution, performance evaluation and subcontracting services.     

Can the new ISO Guide 25/EN 45001 create better confidence in laboratory operations?

 Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process. The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration laboratories is foreseen to come from closer interaction between laboratories and their customers.     

Revision of ISO guide 25

 ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.     

Proficiency testing in analytical chemistry, microbiology and laboratory medicine: working discussions on current practice and future directions

A summary of the working group (WG) discussions on proficiency testing (PT) and external quality assessment (EQA) held at the EURACHEM Workshop, Istanbul, 3?C6 October 2011, is provided. The six WGs covered a range of issues concerned with current practice and future directions; implementing the requirements of ISO/IEC 17043 by PT/EQA providers (WG1); accrediting PT/EQA providers to ISO/IEC 17043 (WG2); pre- and post-analytical aspects in PT/EQA (WG3); evaluating participant performance in qualitative PT/EQA schemes (WG4); establishing PT/EQA schemes in developing countries (WG5); and establishing acceptability criteria in microbiology PT/EQA schemes (WG6). Delegates with different backgrounds were on each WG in order to capture a range of views and experience from a number of different sectors. Working group representatives included PT/EQA providers, participants in PT/EQA schemes and end-users of PT results such as accreditation bodies and regulatory authorities, from countries around the world.     

The Japanese traceability system and the role of uncertainty evaluation in measurement

 The new traceability system of measurement standards based on the Japanese Measurement Law has been established since November 1993. Some reference materials such as metal standard solutions, pH standard solutions and standard gas mixtures are included in the system together with relevant physical quantities. In this system, primary measurement standard instruments or primary reference materials are designated by the regulation for each quantity. For the practical dissemination of each quantity, accreditation of calibration bodies is recognized by the steering committee under the supervision of the government. In the course of assessment of a candidate calibration body, the concepts of ISO/IEC Guide 25 and ISO/IEC Guide 58 are effectively introduced. For the estimation of reliability, the concept of how to introduce the statistical approach is effectively considered. The method of uncertainty evaluation described in the ISO document entitled "Guide to the expression of uncertainty in measurement" is adopted.     

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.     

Proficiency testing in analytical chemistry, microbiology and laboratory medicine: working discussions on current practice and future directions

A summary of the working group (WG) discussions on proficiency testing (PT) and external quality assessment (EQA) held at the Eurachem Workshop, Rome, 5–7 October 2008 is provided. The eight WG’s covered a range of issues concerned with current practice and future directions; how frequently should laboratories participate in PT/EQA? (WG1); developments in PT/EQA within the EU—what is required in future? (WG2); what issues do developing countries face with regards to PT/EQA? (WG3), what issues are specific to microbiology PT/EQA? (WG4); what new fields are emerging for PT/EQA? (WG5); what will be the impact of the new ISO/IEC 17043 standard? (WG6); do current PT/EQA schemes meet the needs of participants? (WG7); and what are the issues that affect the quality of proficiency test items? (WG8). Delegates with different backgrounds were on each WG in order to capture a range of views and experience from a number of different sectors. Working group representatives included PT/EQA providers, participants in PT/EQA schemes and end users of PT results such as accreditation bodies and regulatory authorities, from countries around the world.     

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).     

Proficiency testing on the analytical control of precious metal production

Our experience of executing proficiency testing programs on the analysis of precious metals and precious metal bearing materials is summarized. Six proficiency testing programs of the ”distributed sample testing” type were carried out using samples essentially distinct from each other: (I) certified samples of fine gold and fine silver, and (II) recoverable raw (scrap and catalyst waste) containing precious metals of unknown contents. The test results were assessed using the London Bullion Market Association (LBMA) rules and by Z-criteria using the ISO/IEC Guide 43 scale. Satisfactory results were presented by all participants for the analysis of certified samples of fine gold and fine silver. The results of catalyst waste analysis agreed rather well, whereas the scrap analysis revealed an essential discrepancy in the data for some samples. The reasons for such discrepancies are discussed. Received: 9 June 2000 Accepted: 21 November 2000     

Review of the new edition of ISO 13528

The international standard ISO 13528 is an important reference document for proficiency testing providers and testing laboratories alike, which provides guidance on the use of statistical methods in proficiency testing. With a view to bringing the document in harmony with the ISO/IEC 17043:2010, the first edition of ISO 13528 was revised and the new edition was published in September 2015. This paper attempted to review and discuss the major changes introduced in the new edition of ISO 13528, particularly the part on statistical design with respect to the objective of proficiency testing scheme and the considerations on assigned value determination and performance scoring. Moreover, procedures provided in the new edition of ISO 13528 for qualitative proficiency testing schemes and various robust statistical methods would also be briefly discussed in the paper.     

Estimation of measurement uncertainty in food microbiology: The ISO approach

Given the current interest in measurement uncertainty (MU) in food microbiology, in particular for laboratory accreditation purposes, and the need to have harmonized reference documents specifically in that area at the international level, ISO is conducting works to meet this need. An ISO Technical Specification (ISO/TS 19036) is being prepared on MU estimation for quantitative determinations. A global approach has been chosen, based on the reproducibility standard deviation of the final result of the measurement process. Three possibilities are envisaged for the estimation of the reproducibility standard deviation, in a decreasing order of preference: The intra-laboratory standard deviation, the inter-laboratory standard deviation derived from method validation, and the inter-laboratory standard deviation derived from proficiency testing.The uncertainty of qualitative determinations is still under investigation, and will be covered by a separate ISO publication. Presented at AOAC Europe/Eurachem Symposium March 2005, Brussels, Belgium     

Accreditation of PT providers – is it worth the money?

This topic is being presented from two perspectives, namely the views of an accreditation body and those of an accredited provider of external quality assessment schemes. The first perspective, from an accreditation body, is based on the experience of Australia's national laboratory accreditation body (NATA), which has accredited fourteen proficiency testing (PT) providers and is currently processing an application from another. The second perspective is based on the experience of EQUALIS, the national quality assurance organisation for laboratory medicine in Sweden, which was granted accreditation in 2002.Presented at 5^th Eurachem Workshop on Proficiency testing in analytical chemistry, microbiology and laboratory medicine, Portorož (Slovenia) 25–27 Sept 2005