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.     

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 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.     

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.     

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.     

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.     

Strategies for internal quality control in antidoping analyses

Internal quality control (IQC) is one of the most important elements contributing to quality assurance in the laboratory. In this study, the strategy for the implementation of an IQC program to monitor performance of the analytical procedures used in an antidoping control laboratory is presented. Different IQC parameters have been defined according to the aim of the method (qualitative or quantitative, screening or confirmation). They are based on the analysis of control and calibration samples in each analytical batch and on the use of an internal standard in chromatographic methods. IQC parameters for chromatographic and immunological methods and the acceptance criteria used to check the quality control data obtained are described and discussed. These IQC procedures have been applied during routine antidoping analyses of more than 5000 samples per year in a laboratory accredited by the International Olympic Committee (IOC) and meeting the requirements of the quality standard ISO 17025.     

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.     

Establishment of traceability of ammonium nitrogen determination in wastewater

A case study is presented for the establishment of traceability for ammonium nitrogen determination in wastewater in a routine laboratory in order to fulfil the requirements of ISO/IEC standard 17025. The necessary relevant information was obtained from the method validation data, the quality control data and equipment calibration certificates. The method of measurement is described together with the measurement equation, selected traceable reference standards and the associated measurement uncertainty. The major sources of uncertainty of the result of measurement were identified and the combined uncertainty was calculated. Identification of the main uncertainty sources represents the basis for target operations for reducing the measurement uncertainty of this determination.     

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.     

Implementation of quality assurance system to enhance reliability in Chinese handwriting examination

In regard to the tightened standard on the acceptance of forensic evidence at courts, in particular the evidence-based opinion, the forensic community worldwide is striving to improve test reliability through the implementation of quality assurance system. Handwriting examination including Chinese handwriting is a typical traditional forensic discipline that has often been subjected to judicial challenges in courts. In this paper, we present the work practice and the quality control procedure for Chinese handwriting examination in accordance with ISO/IEC 17025, an international standard on general requirements for the competence of testing and calibration laboratories. The examination work constitutes various phases of identification of the characteristic writing features, comparison and evaluation of the significant similarities and differences, interpretation of findings and formation of opinions. With the support of a fit-for-the-purpose quality system complying with the ISO standard, document examiners in this laboratory are obliged to address the criteria as stated in the pre-set quality assurance plan and undertake scrupulous efforts in delivering the scientific work at all stages throughout their examinations. By doing so, personal bias and other subjective factors that cause detrimental influence to the formation of expert opinions would be kept to a minimum.     

Self-implementation of ISO 9001 versus external support: an examination in laboratories involved in chemical measurement

The purpose of this research was to study how externalizing the process of implementing ISO 9001 influences the dissemination of cultural values and practices of quality management in laboratories involved in chemical measurement. Employee attitudes and behaviors may be heavily influenced by factors such as the mix of internal workers and consultants in a work group. Some researchers have described cases in which internal workers develop negative work attitudes and behaviors from having to work with consultants and have demonstrated the need to examine the dynamics between internal workers and consultants to understand the influence of ISO 9001 externalization. Three hundred and fifty-nine useful questionnaires were received. The results showed that implementation occurs most successfully through a process of linked internalization. This category involves limiting the labor of the consultant basically to moderate advising, review and internal audit. The laboratory personnel are responsible for developing the documentation of the ISO 9001 system. The implementation process is run by the members and directors of the laboratory.     

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.     

Conformity assessment and metrology: update on the state of affairs

A couple of years ago, ISO CASCO launched a major project of transforming all the existing ISO Guides on conformity assessment to a comprehensive series of ISO standards 17000 being now in various stages of development. As the concept of traceability underpinning all measurements has been a basic mission of metrology, a number of these standards have a direct bearing on metrology. The series is logically based on a definition standard, ISO 17000, giving, among others, a guidance which activities fall under conformity assessment. The fact that calibration does not, might have important consequences which must yet be assessed. A controversial discussion on some issues has been in progress concerning ISO 17011 on accreditation bodies which touches both on national metrology institutes (NMIs) with an accreditation function and on calibration labs at large. ISO 17040 on peer review could be used with an advantage to support mutual recognition arrangements among a limited number of bodies of a specialized expertise (e.g., CIPM MRA among NMIs under the Metre Convention). ISO 17025 has been the most important standard for the metrology community and has undergone a major overhaul taking on board the uncovered requirements from ISO 9001:2000. In general, the paper will give an update on the developments outlined above and discuss the consequences and further steps from the viewpoint of metrology.     

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。     

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.     

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。     

Accreditation of reference material producers: the example of IRMM's Reference Materials Unit

The potential approaches for third-party assessment of reference material producers are revisited and the activities of the Reference Materials (RM) Unit of the Institute for Reference Materials and Measurements (IRMM) to obtain accreditation to ISO Guide 34 and ISO 17025 are described. Accreditation was related to the Unit as all matrix RM activities of the institute are concentrated there. A management system was established that allows sufficient flexibility to be applicable to a wide range of RMs while being precise enough to ensure compliance with ISO Guides 30, 31 and especially 34 and 35. Accreditation was achieved in 2004 with independent scopes for testing and RM production and was confirmed and extended in 2005. The key aspects of the RM Unit's management system for RM production are presented. Presented at BERM-10, April 2006, Charleston, SC, USA     

Confidence in testing services – new expectations, new rules, new challenges. 5th Eurolab Symposium offered important information and stimulating discussions

The 5th Eurolab Symposium on 4th and 5th October in Edinburgh was the highlight event of Eurolab in 2000, Eurolab’s 10th anniversary year. Under the title: ”Confidence in Testing Services – new expectations, new rules, new challenges” it reflected recent changes and developments in the laboratory scene and focussed on new tasks and challenges. The most essential changes for laboratories are connected with the new standard ISO/IEC 17025 ”General requirements for the competence of testing and calibration laboratories”. Keywords in this respect are uncertainty of measurement and traceability to SI units, requirements on personnel, proficiency testing, customer orientation, and management systems.     

Synergistic relationships between Analytical Chemistry and written standards

This paper describes the mutual impact of Analytical Chemistry and several international written standards (norms and guides) related to knowledge management (CEN-CWA 14924:2004), social responsibility (ISO 26000:2010), management of occupational health and safety (OHSAS 18001/2), environmental management (ISO 14001:2004), quality management systems (ISO 9001:2008) and requirements of the competence of testing and calibration laboratories (ISO 17025:2004). The intensity of this impact, based on a two-way influence, is quite different depending on the standard considered. In any case, a new and fruitful approach to Analytical Chemistry based on these relationships can be derived.