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.     

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).     

Implementation of ISO/IEC 17025 standard in a nuclear analytical laboratory: The KAERI experience

The practical experience on the implementation of ISO/IEC 17025 compliant quality system in a nuclear analytical laboratory of the Korea Atomic Energy Research Institute (KAERI) is described. This paper summarizes the need for a quality system and accreditation, the process of a quality system implementation, the quality system structures, and the formal accreditation of our laboratory by the Korean Laboratory Accreditation Scheme (KOLAS). Also, the improvements in the management, technical and service quality which resulted from implementation of this system are briefly reported.     

Can single-operator laboratories comply with all of the requirements of ISO/IEC 17025:2005?

ISO/IEC 17025:2005 states that its requirements are “applicable to all laboratories regardless of the number of personnel” and would therefore include single-operator laboratories. However, there are reservations as to whether these laboratories can comply with all of the requirements without jeopardizing independence of judgement and impartiality. Similarly, there are some requirements of ISO/IEC 17025:2005 including staff supervision, internal communication processes and appointment of deputies that are considered unlikely to apply to a single-operator laboratory. The ISO/IEC 17025:2005 is widely used as the international standard of quality assurance by which accreditation bodies assess the competency of testing and calibration laboratories. There does, however, appear to exist, disagreement amongst accreditation experts when considering single-operator laboratories. Some accreditation bodies accredit single-operator laboratories, whilst others require additional human resources prior to granting accreditation. This discrepancy leads to unfair competition amongst laboratories as a single-operator laboratory by definition needs less resources (both human and financial) to achieve and maintain accreditation, compared with a laboratory where additional human resources need to be sought prior to and in order to maintain accreditation. The ISO/IEC 17025:2005 is in the process of being revised, and this is an opportune moment to address the issues aforementioned with the aim of removing ambiguity and enhancing clarity. In addition, the hope is to assist the accreditation bodies themselves to adopt a consensus approach when granting accreditation towards single-operator laboratories.     

Measurement uncertainty—policy and guidance documents issued by accreditation bodies

ISO/IEC 17025 contains general requirements for the competence of calibration and testing laboratories, including those for the evaluation and reporting of measurement uncertainty. Some accreditation bodies have issued additional guidance documents and regulations related to uncertainty, five of which are briefly commented on here.Presented at Roche Diagnostics' Workshop on in vitro diagnostics directive. A Nordic event about the implication of traceability and uncertainty in practice, Helsinki, February 13, 2003.     

Experience of implementing of ISO/IEC 17025: conclusions and recommendations of a workshop

The first experiences of implementing of ISO/IEC 17025 have been obtained by the accreditation bodies and laboratories following the standard, and a workshop to discuss the experiences was arranged. This presentation gives the conclusions and recommendations from the workshop based on the lectures and discussions. In general, the adoption of ISO/IEC 17025 has been a smooth process. Received: 28 February 2002 Accepted: 2 March 2002     

The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

Quality system implementation in Member States of the IAEA

The International Atomic Energy Agency (IAEA), through its Technical Co-operation Programme, has supported the establishment of many nuclear analytical and complementary laboratories in Member States. This included the development of capabilities for the use of various nuclear analytical techniques that include alpha, beta, and gamma spectrometry; radiochemical analysis; neutron activation analysis; energy dispersive X-ray fluorescence analysis; and total reflection X-ray fluorescence. As economic, ecological, medical, and legal decisions are frequently based on laboratory results, they need to be based on accepted national and international standards.The IAEA has taken up this important issue to enhance and foster the competitiveness of nuclear analytical laboratories with the consideration that non-nuclear capabilities are equally important. The projects aim at enhanced quality awareness, a concise system for documentation, establishment of standard operating procedures, procedures for validation of methods, surveillance of method performance, systems for sample management, regular qualification of personnel, client liaison and safety. These projects follow the ISO/IEC 17025 standard and promote participating laboratories to maintain a self-sufficient quality system by which they might be able to obtain national accreditation.This contribution describes the general concept of these projects and discusses some of the results achieved.     

Accreditation of GMO detection laboratories: Improving the reliability of GMO detection

Reliable and efficient methods for detecting genetically modified organisms (GMOs) are essential for establishing an effective system for traceability all along the supply chain from seed producers to final consumers. The latter is especially meaningful in European Union and other countries where strict legislations on GMOs were set up. Performance of the methods used in laboratories around the world should be uniform, in order to obtain reliable and comparable results. Accreditation is a suitable system for harmonising procedures in each testing laboratory. In this paper, key elements for the accreditation of molecular biology methods for GMO detection according to ISO/IEC 17025 are described. The procedures described are also valuable for the accreditation of molecular methods for all laboratory diagnostics where qualitative and quantitative characterisation of nucleic acids is needed.     

The lead assessor role in the ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing laboratories by the General Coordination of Accreditation (Cgcre)

This work describes the human resources organization of the General Coordination for Accreditation (Cgcre) in Brazil, in which lead and technical assessors, both internal and external to the National Institute of Metrology, Quality and Technology (Inmetro), assess the competence of calibration and testing laboratories to the ISO/IEC 17025:2005 standard. The “Lead Assessor Project” is presented, which consists of an increase in the responsibilities of lead assessors, in such a way that the Division of Laboratories Accreditation (Dicla/Cgcre) can cope with the increasing demand for ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing laboratories.     

Implementation of a quality management system in meteorological practice in Serbia

An optional approach in the meteorological service Quality Management System (QMS) based on the case study of the Republic Hydrometeorological Service (MHS) of Serbia is presented and discussed in this paper. The idea is to use the ISO/IEC 17025 standard as a base for its QMS development. Main reasons for such a decision and the elements of the implemented solution are presented and discussed. Meteorological testing processes of the MHS of Serbia and relevant ISO/IEC 17025 scope of accreditation are presented. After establishing competencies in meteorological, environmental, and hydrological testing, the MHS of Serbia will develop an integrative ISO 9001 QMS. The Serbian case study could be taken into consideration as one of the options related to the future World Meteorological Organization Quality Management Framework.     

Quality assurance in analytical laboratories engaged in research and development activities

 Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories. Received: 11 July 2002 Accepted: 29 November 2002 Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to M. Valcárcel     

Introducing the concept of uncertainty of measurement in testing in association with the application of the standard ISO/IEC 17025

ISO/IEC 17025 requests laboratories to estimate the overall uncertainty associated with a test result. In many cases this means a new requirement to laboratories. It is essential to understand the importance of the knowledge of the uncertainty of measurements as well as the principle that not always the smallest possible uncertainty is needed, but fitness for purpose has to be achieved. The paper suggests a policy on the implementation of the concept of uncertainty and guidance on how to proceed, taking into account the present state of the art of understanding the problem.     

Current best practice for traceability in testing laboratories,when certified reference materials are unavailable

Since the implementation of ISO/IEC 17025 in 2002, all accredited laboratories (at the least) need to establish traceability in all their tests and calibration methods. Traceabilty, though well understood in the calibration field (through an unbroken chain of comparisons to the International System of Units —SI), is less straight forward and not so well understood in the testing laboratories. Traceability in analytical and biological testing is found through the use of reference materials, and the validated steps of a test method. This article describes the possibilities to comply with the traceability requirement of ISO/IEC 17025 in testing laboratories , when certified reference materials are unavailable.Presented at the Second International Conference on Metrology—Trends and Applications in Calibration and Testing Laboratories, 4–6 November, 2003, Eilat, Israel     

A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories

The introduction of quality management systems (QMS) and the accreditation of laboratories according to ISO/IEC 17025 standard are not easy tasks, mainly for those laboratories located at teaching and research institutions. During the implementation of QMS at two testing laboratories of the Federal University of Rio Grande do Sul in Brazil, new solutions to overcome some of the difficulties inherent to this type of environment have been found. The knowledge acquired through this work has led to the proposition of some general steps incorporating a process approach presented in this article, which could be of use to laboratories in their pursuit for accreditation. This proposal suggests the use of strategic planning information, links the QMS objectives to the corresponding processes and sets a few indicators to monitor both performance of and improvements to the system.     

Experience of implementing ISO 17025 for the accreditation of a university testing laboratory

The experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory, is presented in the example of the Environmental Radiology Laboratory. Such implementation in a university institution is a difficult task, since the setting and environment are both unfavourable. The particularities are the collaboration of many independent units of the university, and the involvement of teachers and young researchers who have to coordinate all these different tasks, which makes the number of people working quite variable. Some specific aspects of the system are discussed. The conclusion is that implementation of a quality system on ISO 17025 and accreditation are completely achievable, and are helpful activities to put university members in touch with the real world and broaden their minds, which in the end has a positive impact on research studies and academic content.     

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.     

符合ISO/IEC指南25-1990的实验室质量体系向ISO/IEC 17025-1999标准过渡的文件修改

按照ISO／IEC指南25－1990建立起较完善的质量体系的实验室,可通过对质量体系文件进行适当增补或少量删减,以实现向ISO／IEC 17025－1999标准的过渡。对质量手册,按照ISO／IEC指南25－1990的13个要素逐个讨论了具体的增删内容;对程序文件,则按ISO／IEC 17025－1999要求逐个列出了应有的程序。     

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 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.