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.     

The benefits calibration and testing laboratories may gain from ISO/IEC 17025 accreditation

By definition (effectiveness through efficiency), quality is a business interest, not a supreme value in its own right. Quality systems must be beneficial to the organization operating them. In this paper, the possible tangible advantages (both business- and operations-related) an accredited laboratory may draw from formal accreditation is viewed. Also, an attempt is made to roughly classify laboratories into those which are more likely, or less so, to benefit from accreditation.     

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.     

Influence of a quality system complying with the requirements of ISO/IEC 17025 standard on the management of a gamma-ray spectrometry laboratory

The motives for and the implementation of a quality system complying with the requirements of the ISO/IEC 17025 standard in a gamma-ray spectrometry laboratory are briefly described, as well as its influence on the laboratory's work and output. The use of the quality system as a tool for managing and controlling the state of the laboratory is described. Two examples of control and improvement of the laboratory's performance are given.     

ISO 17025 quality system in a university environment

The experience of working under an ISO 17025 compliant quality system in a university environment is described in the example of the Testing Centre of University of Tartu. University-specific features of the quality system include that the Testing Centre acts as the “quality system server” for other units of the university and graduate students participate in the work carried out under the quality system. The benefits for the university and the graduate students are discussed. It is concluded that implementation of an ISO 17025 compatible quality system in a university is fully accomplishable and gives significant added value to the university by helping to destroy the ivory tower perception about universities and by introducing real-world flavour into the studies and broaden the minds (quality awareness) of the students.     

Current American landscape in laboratory accreditation according to ISO/IEC 17025

Accreditation and Quality Assurance - The number of laboratories worldwide seeking accreditation has increased considerably in the last years. These laboratories are from different institutions,...     

Correction to: Motivations,benefits and challenges on ISO/IEC 17025 accreditation of higher education institution laboratories

Accreditation and Quality Assurance - Unfortunately, figure 3 was incorrectly published in the original publication and the correct version is updated here.     

ISO 17025: practical benefits of implementing a quality system

As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.     

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.     

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.     

Unification of the quality assurance systems of public health laboratories conformed to ISO 17025, ISO 15189, and ISO 9000: a major organizational change

The Department of Public Health Laboratories consists of five major laboratories located across the country of Israel: four environmental laboratories performing microbiological and chemical testing of food and water products [accredited according to International Organization for Standardization (ISO) 17025 since 1999) and a fifth laboratory that is dedicated to virology testing (certified according to ISO 9000 since 2003). Historically, each laboratory operated independently and developed its own quality assurance (QA). On November 2004, an important strategic decision was made: to unify all five laboratories’ QA systems conformed to ISO 17025, ISO 15189, and ISO 9000—a transition from five laboratories operating independently in the field of QA toward establishing a multisite laboratory. This process was considered and visualized as a major organizational change and therefore raised some resistance among both QA managers and the professional laboratories’ management. Thus, it was necessary to overcome the resistance and at the same time induce thoughts of ways of reshaping and formatting the new and uniform quality manual and uniform standard operating procedures (SOPs). In September 2005, the first phase of the process was completed, and all four environmental public health laboratories successfully passed a reaccreditation audit using a uniform QA manual guide and partially uniform SOPs. We shall share our experience and discuss the major contributions of this process to overall laboratory management. Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel.     

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     

Proficiency testing in food microbiology: experience from implementation of ISO/IEC 17043 and ISO/TS 22117

The proficiency testing (PT) scheme ??AQUA?? for food microbiology was organised by the Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe) according to ISO/IEC 17043 and ISO/TS 22117. This paper describes the IZSVe experience on the application of the above-mentioned standards for the PTs, with focus on the Enterobacteriaceae enumeration one. Freeze-dried food matrices contaminated with American Type Culture Collection bacterial strains were used as test samples for each microbiological PT organised by IZSVe. The sample homogeneity and stability were verified prior to distribution to participants and throughout the PT, respectively. The participating laboratories analysed samples using their routine methods, and results were transmitted to IZSVe. Data and methods used by each participating laboratory were analysed in order to evaluate the laboratory performance. With reference to the Enterobacteriaceae PT, the test samples were homogeneous and stable. In addition, most laboratory results were obtained using equivalent test methods. Statistical approaches applied to analyse data generated from all participating laboratories revealed similar outcomes as no significant outlying count and only 5?% of unacceptable results were observed. Finally, the z-score, with the standard deviation that does not vary from round toround, was applied to compare and to evaluate the performance of each laboratory over time highlighting possible persistent trends over several rounds.     

Development and accreditation to ISO/IEC 17025 calibration status of a melting point measurement facility for the UK

A melting point measurement facility for the UK has been developed and accredited to ISO/IEC 17025 Calibration status for the determination of the liquefaction temperature of pure substances from 35 to 250°C. The facility is based upon a commercial instrument, i.e. an oil bath fitted with an aluminium block (Isotech, model 798 EHT), a precision multimeter (Isotech TTI-7), a thermocouple directly inserted in the sample under investigation and a platinum resistance thermometer (PRT) tracking the block temperature. The homogeneity of temperature bath/block was investigated and the PRT used for the traceability of the measurements was calibrated by NPL and traceable to ITS-90. The process was validated using four current LGC Certified Reference Materials (CRMs):

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.     

Meeting the measurement uncertainty and traceability requirements of ISO/IEC standard 17025 in chemical analysis

The new laboratory accreditation standard, ISO/IEC 17025, reflects current thinking on good measurement practice by requiring more explicit and more demanding attention to a number of activities. These include client interactions, method validation, traceability, and measurement uncertainty. Since the publication of the standard in 1999 there has been extensive debate about its interpretation. It is the author's view that if good quality practices are already in place and if the new requirements are introduced in a manner that is fit for purpose, the additional work required to comply with the new requirements can be expected to be modest. The paper argues that the rigour required in addressing the issues should be driven by customer requirements and the factors that need to be considered in this regard are discussed. The issues addressed include the benefits, interim arrangements, specifying the analytical requirement, establishing traceability, evaluating the uncertainty and reporting the information.     

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.