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     

Summary of ISO/TC201 technical report: ISO/TR 18392: 2005—Surface chemical analysis—X‐ray photoelectron spectroscopy—Procedures for determining backgrounds

ISO Technical Report 18392 provides the guidance for determining backgrounds in X‐ray photoelectron spectra. The methods of background determination described in this report are applicable for the quantitative evaluation of the spectra of photoelectrons and Auger electrons excited by X‐rays from solid surfaces and surface nanostructures. Copyright © 2006 John Wiley & Sons, Ltd.     

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.     

Uncertainty estimation in measurement of pKa values in nonaqueous media: A case study on basicity scale in acetonitrile medium

The difficulties in estimating uncertainty of pK_a values determined in nonaqueous media are reviewed and two different uncertainty estimation approaches are presented and applied to the pK_a values of the compounds on a previously established self-consistent spectrophotometric basicity scale in acetonitrile. One approach is based on the ISO GUM methodology (the “ISO GUM” approach) and involves careful analysis of the uncertainty sources and quantifying the respective uncertainty components. The second approach is based on the standard-deviation-like statistical parameter that has been used for characterization of the consistency of the scale (the “statistical” approach). It is demonstrated that the ISO GUM approach somewhat overestimates the uncertainty. The statistical approach is based on long-term within-laboratory statistical data and it is demonstrated that it underestimates the uncertainty. In particular it neglects the laboratory bias effects that are taken into account at least to some extent by the ISO GUM approach. Thus, together these two approaches allow to “bracket” the uncertainties of the pK_a values on the scale. The uncertainties of the pK_a values are defined in two different ways. Definition (a) includes the uncertainty of the pK_a of the reference base (anchor base of the scale) pyridine. Definition (b) excludes it. It is demonstrated that both definitions have their virtues. Definition (a) leads to the uncertainty ranges of 0.12-0.22 and 0.12-0.14 pK_a units at standard uncertainty level for different bases using the ISO GUM and statistical approach, respectively. Definition (b) leads to the uncertainty ranges of 0.04-0.19 and 0.02-0.08 pK_a units, respectively. The uncertainty of the pK_a of a given base is dependent on the quality of the measurements involved and on the distance from the reference base on the scale. The importance of the correlation between the pK_a values of bases belonging to the same scale is stressed.     

Additive manufacturing approaches for biological power generation

As the consequences of global warming continue to affect the climate, there is an increased need for technologies that decrease dependence on fossil fuel consumption and promote sustainability. Additive manufacturing (AM) not only enables the scale-up and mass production of renewable energy technologies but also reduces cost and lead time, minimizes waste, and uses less energy than traditional manufacturing processes. Moreover, AM brings design and innovation to the forefront by allowing for design strategy revision and rapid prototyping. Herein, AM approaches used to fabricate devices that enable biological power generation are described. Biological power generation is a process through which biocatalysts – electroactive bacteria, enzymes, or cyanobacteria – harvest electrons from chemical substrates or light. Device engineering directs electron transfer events to a conductive material and maximizes power output. This review covers recent AM approaches for biological power generation in the form of microbial fuel cells (MFCs), enzymatic fuel cells, and biophotovoltaic cells with an emphasis on MFCs. Fabrication methods and materials for electrodes, chambers, inserts, membranes, and biofilms are described, along with impacts on device performance.     

Comparison of permeation resistance of protective gloves to organic solvents with ISO, ASTM and EN standard methods

In this study, the permeation resistance of nitrile and neoprene gloves to benzene and 1,2-dichloroethane was investigated using two permeation cells according to the ISO 6529, ASTM F739, and EN 374-3 standard test methods. The permeability coefficients were found to significantly increase with the flow rate of the collection medium. The appropriate flow rate of nitrogen collection should be higher than 75 and 150 mL/min for the ISO 6529 and ASTM F739 cells, respectively. For an open-loop system, the permeability coefficient of the ISO 6529 cell was obviously greater than that of the ASTM F739 cell, and the difference between these two cells was statistically significant. On the other hand, the breakthrough time was about 20–30 min for either the ISO 6529 or ASTM F739 cell at different flow rates of nitrogen collection. Fick's diffusion coefficient and solubility of permeant in the polymer glove can be specified as alternative test results for standard methods.     

Implementation of ISO 9002 for research in occupational epidemiology

 The Department of Epidemiology, which forms part of the French National Institute for Research and Safety (INRS), is involved in research on occupational risks. It provides results of industry-based epidemiological studies focused on the relationship between occupational exposure and diseases of the respiratory system, central and peripheral nervous systems and cancer. This paper describes the Quality Assurance System developed by our department, which has been successfully maintained and extended since being granted ISO 9002 certification by the French Association for Quality Assurance. The quality system includes procedures specific to epidemiological study conduct and scientific peer reviews. It has been designed in order to meet the required ISO elements, including quality aims and policy, quality procedures for management of personnel, sub-contractors and facilities, nonconformities, corrective and preventive actions, archiving and traceability and planning of internal quality audits. Improvements in management, technical and service quality have resulted from this process. Although epidemiological studies differ markedly from industrial production for which the standards were originally drawn up, we have found that Quality Assurance is both applicable and useful in epidemiological research on occupational risks. Therefore, we conclude that a certified Quality Assurance Scheme including scientific peer reviews can be recommended to ensure reliable epidemiological results. Received: 22 July 1998 · Accepted: 5 October 1998     

ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry

ISO 9001 certification (currently ISO 9000:2000) implies that an organization is managed in a quality manner. ISO certification is primarily achieved by audits that show that a company follows its own procedures. These procedures are prepared by the company with few ISO requirements. ISO procedures are flawed in two ways: they can represent only part of what an organization does within a process, and they often lack sufficient detail. The latter limitation allows both adequate and inadequate tasks. Often, people pay attention to ISO only when audits are imminent, which contrasts with other quality initiatives that have goals directly related to quality with frequent measurements and continual involvement by staff. There does not appear to be any connection between company successes or failures and ISO certification, and failing an ISO audit is a rare event. All of this leads one to conclude that ISO 9001 has had no effect on quality. In addition, there is a danger that flexible or so-called horizontal ISO standards that lack detail will supplant more traditional standards, which prescribe a procedure that has been agreed to by a consensus of experts. Improving ISO 9001 starts with recognizing its limitations. Recommendations regarding ISO certification include: dropping it, minimizing resource allocation to it, and trying to change it.     

Quality management systems from the perspective of organization of complex systems

The aim of this model is to analyse quality management systems from the standpoint of the organization of complex systems introduced by Robert Rosen. The concept that an organized system, under certain conditions, can be modelled as a living system introduces unsuspected tools to analyse its behaviour. The model is oriented towards the understanding of the implications of modifications introduced in laboratories working with a quality organization following the ISO/IEC 17025 standard.This standard establishes management and technical requirements concerning the documental organization, control of the management and technical records, personnel, equipments, test or calibration methods, etc. The objective of the quality system implementation is to assure the quality of the product, the special consideration being the customer’s satisfaction with all aspects of the service the laboratory offers.The improper use of the quality system tools has an impact on the laboratory activity. The perception of this fact can be negligible at the moment it happens. The model allows us to realize that this alteration always has a negative impact on the customer and it specially affects the continuous improvement that the laboratory must implement.     

Proposed guidelines for the final review of measurement results in the clinical laboratory

The standard ISO 15189 requires a systematic review of results of clinical laboratory examinations, but it does not provide details on how to carry out such a review. In this article, the Catalan Association of Clinical Laboratory Sciences proposes a guide for this review of patients’ clinical laboratory results pertaining to rational or difference scales (‘quantitative values’). The review process is based on the so-called plausibility control, which may be defined as the set of procedures used to decide if a measurement result is valid or not according to established clinical and biological criteria, considering four variables: (1) alert limits; (2) consistency with the previous result, if any; (3) consistency with other results obtained from the same sample, if any; and (4) consistency with the diagnosis (presumed or confirmed) or, when it is not known, the origin of the request, though these last criteria are generally very weak and the derived decisions may be scantly reliable. This guide has been prepared on the behalf of the Technical Committee of the Catalan Association for Clinical Laboratory Sciences. Papers published in this section do not necessarily reflect the opinion of the Editors, the Editorial Board and the Publisher.