From a single analyzer to multiple instruments—The GUM approach

Assessment and expression of analytical quality have become novel spotlights in medical laboratories since accreditation began in the early 1990s, in Europe. Evaluation of uncertainty of measurement by definition was launched in Finland when the Finnish Accreditation Service (FINAS) accredited the first medical laboratories in the mid 1990s. In spite of all the analytical and statistical knowledge which has been available in medical laboratories for years, evaluation of total uncertainty of measurement has not yet caught on. The concept is still unfamiliar to experts and, indeed, little guidance has been available. National and international activities, with good results, can be shown when the educational aspect is considered. The Guide to the Expression of Uncertainty in Measurement (GUM) remains the main document for uncertainty evaluation. Uncertainty of measurement together with target value of uncertainty can be used as a good measure for analytical quality in large or smaller laboratories over time, because it is a quantitative indication and the evaluation is easy to repeat as running practical tools are available.Presented at the 8th Conference on Quality in the Spotlight, 17–18 March 2003, Antwerp, Belgium     

A pilot experiment of joint assessments by accreditation and certification bodies in clinical laboratories

When the quality system of the health care organization is certified and the laboratory accredited, two different types of assessments are also performed. To reduce the extra work caused by these different assessments the Finnish Accreditation Service FINAS and SFS-Certification have made a pilot experiment in combining the assessments. Joint assessments have been a positive experience to the laboratory as well as to the assessing bodies, and we find this operating model worth developing.     

The influence of a quality system according to ISO/IEC 17025 on the performance of Brazilian laboratories in proficiency testing in the environmental area

This paper presents a performance analysis of laboratories in proficiency testing (PT) with the main objective of evaluating whether having accreditation to ISO/IEC 17025 or not having an implemented quality system has an influence on the performance of these laboratories. This research was conducted with data from an accredited PT scheme of physical–chemical water analyses. Nine metals were considered in the analysis, with a total of 896 results. The performance indicator was z-score. The proposed analysis was conducted through statistical methods of analysis of variance, Dunnett’s test, Chi-square and cross-tabulation. It was verified that there is a significant difference between the performance of accredited laboratories, recognised laboratories, and laboratories that do not have an implemented quality system. It was established that an accredited or recognised quality system has a positive influence on the laboratory performance, resulting in a lower z-score (in module) and in a larger percentage of satisfactory results.     

From misconception to a must: The measured merits of total quality management and accreditation in INAA

Increasingly govemmental bodies and industry require that supporting analytical laboratories have their quality assurance program implemented in a quality system by international standards such as derived from the ISO-25 guide. Neutron activation analysis (NAA) laboratories may have to deal with this trend too. In universities and research laboratories the need for it, and the implications of total quality management system are sometimes misconceived by unfamiliarity with the issue. The laboratory for INAA in Delft has been accredited for its quality system since 1993. Some of the tangible improvements since the introduction of quality management are presented. Four strategical considerations are given to consider the introduction of quality management at NAA laboratories, viz. with respect to the role of NAA for the validation of other methods, the role of NAA in the certification of reference materials, the preservation of knowledge and the acceptance of NAA as a respectable method.     

The ILAC Arrangement – Part I

As of August 2001, 38 laboratory accreditation bodies of the International Laboratory Accreditation Cooperation (ILAC) have signed the multi-lateral, mutual recognition arrangement (the ”ILAC Arrangement”) to promote the acceptance of accredited test and calibration data. This Arrangement provides significant technical underpinning to international trade. Until now, there has been no international mutual recognition agreement in laboratory accreditation, which has been a hindrance for some types of international trade. The key to the Arrangement is the developing global network of accredited testing and calibration laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies. The signatories have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. Now that the ILAC Arrangement is in place, governments can take advantage of it to further develop or enhance trade agreements. The ultimate aim is increased use and acceptance by industry, as well as government, of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of ”a product tested once and accepted everywhere” can be realised.     

Accreditation for United States environmental laboratories

 There is currently no national program for recognition of United States environmental laboratories. This situation should change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency test samples, and meet specified quality assurance standards.     

The development of a National Accreditation System in South and Southern Africa

 In South African industry there is a strong appreciation of Quality Assurance. More than 1400 companies have been certified as complying with ISO 9000, and this, of course, has resulted in a strong demand for accredited calibration and test facilities. Work on the development of a national calibration service started in 1976, and the South African National Calibration Service (SANCS) was inaugurated in 1980 with 13 calibration laboratories. The early maturity of the SANCS can be judged by the fact that by 1984 it had the technical capability to establish a mutual recognition agreement with a European country. It now has a total of some 191 accredited laboratories, 139 calibration laboratories and 52 testing laboratories. In 1993, the SANCS signed mutual recognition agreements with the CNLA (Taiwan) and the European Co-operation for the Accreditation of Laboratories (EAL). In 1994 it entered the field of testing laboratory accreditation and is already experiencing a strong influence therefrom, and in 1997 it changed its name to National Laboratory Accreditation Service (NLA). In May 1995, the NLA was appointed by the Department of Trade and Industry to establish a South African National Accreditation System (SANAS). Progress with this work up to the present time has been substantial.     

Integration of parallel-operating quality systems

Since the 1980s, quality systems have become an essential element in successful companies and institutions. Today those systems are indispensable to fulfill the needs of the customers and last but not least the requirements of the society. Depending on the company's activities and fields of services, it is necessary to establish various quality systems. The Institut Fresenius (IF) Group runs a number of analytical laboratories and sampling groups. The whole group was accredited according to DIN EN 45001 in 1994. Good Laboratory Practice (GLP) was introduced in 1992 and was certified by the national authority. For certain customers, IF Group is also obliged to work according DIN EN ISO 9001 or GMP. A comparison of these systems with respect to their different priorities shows the possibility of integrating their rules into one comprehensive quality system. The IF Group has therefore installed a quality system operating in parallel. Multilocation accreditations and/or certifications are taking these efforts into account. The benefits are: high transparency of the system for the customers, auditors and personnel, a reduction of maintenance costs, and great flexibility to react to new standards. Could these activities lead to a new Integrated Management System?     

Measurement uncertainty: practical problems encountered by accredited testing laboratories

Following the introduction of ISO 17025 in 1999, all accredited testing laboratories have started to implement a procedure for estimating measurement uncertainties for the analytical methods that they employ. These procedures and uncertainties are an integral part of the quality system of the accredited laboratory and are therefore reviewed during audits by the accreditation bodies. In January/February 2004 the status of measurement uncertainties available at accredited testing laboratories was evaluated. It was found that most laboratory customers do not make use nor want to make use of the available measurement uncertainties. Furthermore, the current lack of standardisation has caused the estimated measurement uncertainties to vary widely, even for the simplest determinations.

     

Homogeneity check of agricultural and food industries samples using near infrared spectroscopy

Samples distributed in proficiency testing schemes (PTS) need to be homogeneous in order to be sure that if a laboratory has a result different from the other laboratories, its error can be attributed to its analysis method and not to its sample. This control must be done according to the ISO 13528 draft standard before sending the samples to the laboratories. It can be done by determining homogeneity targets by sub-contracting to accredited laboratories using reference methods, but this engenders logistic and financial problems. That is why a homogeneity check using Near Infrared Spectroscopy (NIR) has been developed for agricultural and food industries samples prepared for PTS at Bipea (Bureau Interprofessionnel d'Etudes Analytiques). To evaluate the homogeneity among samples, this procedure involves a comparison of NIR spectra, the determination of global homogeneity criteria and the use of control charts. The method of control developed and carried out at Bipea allows the rapid and easy monitoring of the performance of the sample preparation.     

ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting

Accreditation of healthcare services is recommended to ensure operation according to the highest quality standards. Various initiatives, such as legislation or accreditation by ISO or JCI, may be active to support and improve quality. The growing trend toward JCI hospital accreditation raised the concern of redundancy between JCI requirements for the use of referral laboratories and the ISO 15189 accreditation for medical laboratories. This would result in needless administrative efforts for hospital laboratories to collect and maintain required documentation, as the JCI quality requirements would be guaranteed given that the referral laboratory is ISO 15189 accredited for those examinations. A consensus meeting was organized by the Working Group for Hospital Accreditation of the Belgian Zorgnet-Icuro network, the University Hospitals of Leuven and the Red Cross to discuss the avoidance of any redundancy between both standards and to issue best practice guidelines for referral laboratories. It was concluded that JCI measurable elements for referral laboratories are covered by the ISO 15189 accreditation scope. The article substantiates the consensus that JCI and ISO quality requirements are harmonized and that accurate knowledge and interpretation of prevailing quality standards are essential to avoid redundancy in quality measures.     

EAL interlaboratory comparison Wa1 – Testing of potable water

 The accreditation of laboratories has emphasized the use of interlaboratory comparisons as a tool to monitor the comparability and accuracy of results laboratories produce. An interlaboratory comparison for water laboratories was organized among European Cooperation for Accreditation (EA) member countries; 30 laboratories, 7 of which were not accredited, from 14 European countries participated in this intercomparison. All the laboratories were chosen by the appropriate national accreditation bodies, with the instruction to select as participants those laboratories which act as national reference laboratories in this field. About 90% of the data collected was considered satisfactory after statistical treatment. Non-accredited laboratories performed as well as accredited laboratories. The laboratories were asked to take corrective action and report the corrections to the accreditation bodies. A great variation in the reported uncertainties of the results was observed. There seems to be a need to organize EA interlaboratory comparisons for national reference laboratories analysing water. It is obvious that even reference laboratories need training in how to estimate the uncertainty of results. Received: 22 July 1998 · Accepted: 21 September 1998     

Policies and criteria on accreditation of testing laboratories in Korea

Policies and criteria for the accreditation of testing laboratories in Korea are reviewed according to the laws and regulations within the organizational framework. According to the Weights and Measures Act, the administrator of Korean Industrial Advancement Administration (KIAA) may accredit qualified testing laboratories in Korea. Criteria, procedures, and surveillance of accredited laboratories are specified in the Enforcement Regulation of the Weights and Measures Act drawn up by the Ministry of Trade, Industry, and Energy. Further detailed accreditation criteria and processes are prescribed in the Operation Guideline for the Accreditation of Testing Laboratories prepared by the KIAA. The Korean Laboratory Accreditation Scheme (KOLAS) of the KIAA is the authorized representative institution for the accreditation of testing laboratories in compliance with the ISO Guides 25/58 and the Operation Guideline for the Accreditation of Testing Laboratories. Finally, the current status of accredited laboratories in Korea is briefly described.     

The increasing demands of quality assurance in chemical testing

The chemical and microbiological testing community is going through a rather difficult period of change. Publication of ISO/IEC 17025 (General requirements for the competence of Calibration and Testing Laboratories, 1999) [1] is placing additional demands on testing laboratories to ensure traceability and estimate uncertainty in their measurements. At the same time, laboratories must remain mindful of the need to provide relevant, timely and economic services to their clients. International Accreditation New Zealand (IANZ) and its accredited laboratories are currently focussing on establishing realistic methods for ensuring traceability to national and international standards and estimating measurement uncertainty. To this end, IANZ recognizes that it has an important role in providing as much advice and assistance as possible, not only to its accredited chemical laboratories but also to all those contemplating accreditation in New Zealand.

Measurement uncertainty: practical problems encountered by accredited testing laboratories

Following the introduction of ISO 17025 in 1999, all accredited testing laboratories have started to implement a procedure for estimating measurement uncertainties for the analytical methods that they employ. These procedures and uncertainties are an integral part of the quality system of the accredited laboratory and are therefore reviewed during audits by the accreditation bodies. In January/February 2004 the status of measurement uncertainties available at accredited testing laboratories was evaluated. It was found that most laboratory customers do not make use nor want to make use of the available measurement uncertainties. Furthermore, the current lack of standardisation has caused the estimated measurement uncertainties to vary widely, even for the simplest determinations.     

A new internal quality control chart based on biological variation

The instruments and analytical methods currently used in clinical laboratories today have better precision and stability than those used in the past. With the development of chemical and immunological methods and instrumentation technology, test precision has increased. However, the application of the Westgard multirule procedure to control sera in the Levey-Jennings chart may not be useful or cost-effective. We devised a new test-specific decision limit for accepting or rejecting runs based on the data of within-subject biological variation and prepared a control chart. We then applied these new limits and control chart to a group of tests performed in our laboratory. With the exception of the tests for albumin, total protein, and calcium, for which desirable performance standards could not be attained with the current technology and methodology, the application of these control limits was cost-effective and convenient. It is estimated that the value of healthy within-subject biological variations is constant, irrespective of the methodology, the area in which the study has been performed, and the number of subjects included in the study. We believe that control limits based on biological variation are reliable and cost-effective, and may be useful in modern and accredited laboratories.     

Experience of accreditation in a surface science laboratory

The analytical laboratory MateC of Fondazione Bruno Kessler has successfully offered material characterization on international research and development market for the last 25 years. Since the beginning, this market has drastically changed becoming more exacting for higher standards, and introducing a quality management system became mandatory for a successful operation. In order to pursue the market and customer needs, the MateC activities have been accredited according to ISO/IEC 17025 quality management standards. This paper summarizes many years’ experience of work under the ISO/IEC 17025 compliant quality system standard in a surface science laboratory for performing material characterizations, considering all significant pros and cons.     

Implementation of a quality management system in university test laboratories: a brief review and new proposals

Quality management systems are difficult to implement in university laboratories involved in teaching activities, R&D and provision of testing services, because of their peculiar characteristics. Testing services are not a priority, the performance of professionals is measured based on their teaching activities and publications, and the laboratories are shared with research and teaching activities. Hard efforts were made all around the world to overcome some of these difficulties. This paper analyzes the process of implementing a quality management system according to the ISO/IEC 17025 standard at two laboratories of the Federal University of Rio Grande do Sul, in Brazil. Some new solutions to solve the main problems typically originated on this type of environment are presented and compared with reports from the literature. It was concluded that it is perfectly possible for university laboratories to have their tests accredited according to standard ISO/IEC 17025, respecting their peculiarities and adopting creative solutions that meet the characteristics and the needs of each institution.     

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.