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.     

APLAC interpretation and guidance on the estimation of uncertainty of measurement in testing

The Asia Pacific Laboratory Accreditation Cooperation (APLAC) is the organization representing the community of bodies that accredit testing and calibration laboratories throughout the Asia Pacific region, including China and North America. APLAC members assess the competence of laboratories and grant them accreditation. They also provide mutual recognition of the equivalence of their accreditations, which facilitates international trade and acceptance by regulators. Harmonization of accreditation requirements is therefore vital to maintaining Mutual Recognition Arrangements. APLAC establishes management and technical criteria for accreditation and publishes guidance documents for accreditation bodies and laboratories.     

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.     

Setting a precedent in international accreditation

 The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed. Received: 30 May 1997 · Accepted: 16 June 1997     

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.     

Proficiency testing program for the determination of total arsenic, cadmium, and lead in seawater shrimp

The proficiency testing (PT) program for 97 worldwide laboratories for determining total arsenic, cadmium, and lead in seawater shrimp under the auspices of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) is discussed. The program is one of the APLAC PT series whose primary purposes are to establish mutual agreement on the equivalence of the operation of APLAC member laboratories and to take corrective actions if testing deficiencies are identified. Pooled data for Cd and Pb were normally distributed with interlaboratory variations of 21.9 and 34.8%, respectively. The corresponding consensus mean values estimated by robust statistics were in good agreement with those obtained in the homogeneity tests. However, a bimodal distribution was observed from the determination of total As, in which 14 out of 74 participants reported much smaller values (0.482-6.4 mg/kg) as compared with the mean values of 60.9 mg/kg in the homogeneity test. The use of consensus mean is known to have significant deviation from the true value in bi- or multimodal distribution. Therefore, the mode value, a better estimate of central tendency, was chosen to assess participants' performance for total As. Estimates of the overall uncertainty from participants varied in this program, and some were recommended to acquire more comprehensive exposure toward important criteria as stipulated in ISO/IEC 17025.     

Laboratory accreditation: The operation of an established scheme

NAMAS, the National Measurement Accreditation Service, was formed in 1985 and has currently accredited some 1050 testing and calibration laboratories in the United Kingdom. NAMAS is managed by an Executive of 60 staff which is based at the National Physical Laboratory, one the UK's largest Government Research Establishments. Laboratories seeking accreditation are assessed by fully trained technical experts contracted by NAMAS, against the criteria set out in the NAMAS Accreditation Standard M10; the criteria contained in this document are fully consistent with the international standards for laboratory accreditation EN 45001 and ISO Guide 25. NAMAS has recently published a document which provides guidance on the interpretation of the NAMAS Accreditation Standard for analytical laboratories. Assessment involves a consultative preassessment visit which is followed by a thorough on-site assessment of a laboratory's quality system and testing activities by a team of expert assessors. Following the correction of any noncompliances found at the assessment, the laboratory receives a certificate of accreditation and a schedule which defines those tests and analyses for which the laboratory is accredited. NAMAS has negotiated a number of mutual recognition agreements with similar accreditation bodies in other countries and negotiations with other schemes are underway. The imminent approach of the European Single Market has highlighted the need for independent third party assurance of testing and calibration and this should ensure the continued growth of NAMAS and similar schemes elsewhere in Europe.     

实验室从ISO/IEC指南25-1990质量体系向ISO/IEC 17025-1999质量体系的过渡

对ISO/IEC17025-1999和ISO/IEC指南25-1990进行了比较，分析了ISO/IEC17025-1999的显著变化，提出了由ISO/IEC指南25-1990质量体系向ISO/IEC17025-1999质量体系过渡的措施。     

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).     

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.     

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.     

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     

Interlaboratory comparison for the determination of five residual organochlorine pesticides in ginseng root samples by gas chromatography

An interlaboratory comparison study for the determination of 5 residual organochlorine pesticides (hexachlorobenzene and 4 hexachlorocyclohexane isomers) in ginseng root was performed. This program [Asia Pacific Laboratory Accreditation Cooperation (APLAC) T049] was the first of its kind for an herbal matrix and involved the participation of 70 laboratories from 26 countries worldwide. Consensus mean values were computed statistically from the reported results, which were eventually used to assess the performance of individual laboratories in terms of the z-scores. The distribution of analytical data was found to be widespread, with standard deviation ranging from 43.9 to 55.9%, and the result patterns obtained were similar to those residue pesticide programs using other matrixes. Although the estimation of measurement uncertainty is a crucial requirement for all quantitative tests for laboratories that meet the requirements of International Organization for Standardization/International Electrotechnical Commisssion (ISO/IEC) 17025, some laboratories in this program had difficulties and showed unfamiliarity with respect to that quality criterion. It was recommended that laboratories review and rectify the situation promptly so that they would have a better understanding of measurement uncertainty or the test service provided.     

Update on the activities of the National Cooperation for Laboratory Accreditation

 The efforts to form a laboratory accreditation cooperation in the United States and North America are described, including activities of the Laboratory Accreditation Working Group and the interim board of the National Cooperation for Laboratory Accreditation. The vision, mission, and guiding principles developed by the two groups are presented, along with the operational documents, such as bylaws, the recognition document, guidance documents and the quality manual drafted by the interim board. Received: 8 June 1998 · Accepted: 16 June 1998     

Implementation of ISO/IEC 17025 Standard for the accreditation of analytical laboratories in Russia

The history since 1992 and the current state of affairs of the Russian Accreditation system for analytical laboratories are described. Some national characteristics of the implementation of the ISO/IEC 17025 Standard in Russia are considered. The elucidation of some ISO/IEC 17025 Standard prepositions is presented to facilitate implementation of the Standard by accreditation bodies and analytical laboratories claiming accreditation.     

Accreditation: a challenge

 This paper describes a real accreditation case from VTT Chemical Technology in Finland. The laboratory has acquired accreditation according to ISO/IEC Guide 25 and EN 45001 for a variety of organic and inorganic environmental tests. The present paper summarizes the reasons for applying for accreditation and selecting the test methods, gives the costs involved, and describes some future developments and views. Also, some details of laboratory intercomparisons and quality system structures are briefly reported.     

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.     

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.     

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.     

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.