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.     

ISO compliant laboratory quality systems and incident monitoring improve the implementation of laboratory information systems

Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS) in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system; this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS. Received: 4 August 2001 Accepted: 21 March 2002     

Using a learning curve approach to reduce laboratory errors

Hospital laboratories have error rates that are too high and in some cases may be responsible for adverse patient treatment. This paper introduces reliability growth management (RGM), which is based on learning curve theory, as a method to improve laboratory error rates. RGM is widely used in the defense and automotive industry to solve problems when resources are limited and knowledge about the product and/or process is incomplete. An example of RGM, which was used to improve the reliability of instrument assay systems in the medical diagnostics industry is presented. RGM is a closed-loop process that entails creating a goal and event model, classifying events with failure review and corrective action system (FRACAS), tracking progress and predicting completion with Duane analysis. Results achieved by RGM were far better than those obtained by previously used methods. RGM techniques can be transferred to hospital laboratories to reduce laboratory error rates. The advantages of RGM compared to other quality initiatives such as ISO 9000 and Six Sigma are discussed. Received: 3 February 2002 Accepted: 17 July 2002 Acknowledgements The majority of the work of transferring reliability growth management from the defense industry to the medical device industry was performed by Keith K. McLain, while he was at Ciba Corning Diagnostics. Keith is now at Ortho-Clinical Diagnostics (email: KMcLain@ocdus.jnj.com). Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations  RGM Reliability growth management · FRACAS failure review and corrective action system · CAP College of American Pathologists · LIS laboratory information system · HIS hospital information system Correspondence to Jan Krouwer     

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.     

Trace analysis of microcontaminations in compliance with ISO 9001: monitoring and diagnostics in large-scale silicon manufacturing

 Severing principles are reported concerning the certification of and quality assurance in a trace-analysis laboratory that handles a large number of real samples, about 60 000 analyses/year with 50 validated methods. ISO 9001 emphasizes monitoring rather than diagnostics. For monitoring purposes the trace-analysis methods must be highly selective and of high precision, with high throughput and uptime within a justifiable economic framework in the analytical range of interest. All trace-analysis methods must be cross-checked using independent analytical tools. The analytical laboratory must be fully integrated in the total quality management of the plant. The analyst must know not only the performance of the trace-analysis tools but also the materials and processes involved in manufacturing. Received: 19 October 1995 Accepted: 15 November 1995     

The Italian way: Accreditation and continuous quality improvement in clinical laboratories

 The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.     

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     

Proficiency testing as tool for ISO 17025 implementation in National Public Health Laboratory: a mean for improving efficiency

Public Health Laboratories (PHL) as part of Public Health Services are involved in law enforcement and ensuring food and water quality. The laboratories had to go through an organizational and monetary change imposed by the growing and changing needs of the state of Israel. The laboratories had to become more modern and to implement new and more sophisticated testing methods. Another requirement was to perform a steadily increasing number of tests and to be more flexible towards customers’ demands. Yet, the budget was not changed accordingly, as the Public Service to which the laboratories belong to do not respond to changing needs. Management realization was that the accreditation process could be used as a tool to achieve organizational and cultural change. Understanding and transformation were required throughout the organization, including management. Proficiency testing is performed for all testing methods in all areas even for non-accredited tests such as clinical tests. Proficiency testing was used as a tool for organizational culture change. It is a great index with game elements, that gives employees and managers the possibility for comparison, fixing problems and corrective action. The demands of ISO 17025 made it necessary to change peoples’ attitudes and views on both professional and communication levels. Laboratory quality consists now on the four main principles, described in the 5M&E model which is typical to small organizations and which ensures a constantly improving system: ”Policy statement”, ”Machine”, ”Material”, ”Measurement”, ”Method”, ”Manpower”, and ”Environment” targeted to achieve ”Quality upgrade”. Slowly we succeeded in providing better and more reliable services and have increased our income on what would hopefully become our way to financial independence. We hope this process would provide the Ministry of Health with a better chance to public health using the same financial sources. Received: 25 October 2000 Accepted: 12 December 2000     

Internal audits in private medical laboratory practice – a Finnish experience in 1996–2000

Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally, audits performed at the workbench were not considered as the best possible for fruitful discussions. Received: 20 February 2001 Accepted: 30 November 2001     

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.     

Quality and timeliness in medical laboratory testing

In terms of testing, modern laboratory medicine can be divided into centralized testing in central laboratories and point-of-care testing (POCT). Centralized laboratory medicine offers high-quality results, as guaranteed by the use of quality management programs and the excellence of the staff. POCT is performed by clinical staff, and so such testing has moved back closer to the patient. POCT has the advantage of shortening the turnaround time, which potentially benefits the patient. However, the clinical laboratory testing expertise of clinical staff is limited. Consequently, when deciding which components of laboratory testing must be conducted in central laboratories and which components as POCT (in relation to quality and timeliness), it will be medical necessity, medical utility, technological capabilities and costs that will have to be ascertained. Provided adequate quality can be guaranteed, POCT is preferable, considering its timeliness, when testing vital parameters. It is also preferred when the central laboratory cannot guarantee the delivery of results of short turn-around-time (STAT) markers within 60 or (even better) 30 min. POCT should not replace centralized medical laboratory testing in general, but it should be used in cases where positive effects on patient care have been clearly demonstrated.     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

The new ISO 17025 – basic idea

 This paper offers a concise overview of the recent draft of ISO 17025, which is expected to replace EN 45001 in 1999. Reference is made to the general area of related ISO standards for management systems. The main changes compared with EN 45001 are discussed for testing laboratories.     

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.     

Quality assurance in the view of a commercial analytical laboratory

 The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses. This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation, can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must be demanded of all laboratories. Received: 4 October 1996 Accepted: 15 January 1997     

Twenty-five years of international collaboration in reference materials via ISO/REMCO

This paper looks back on a quarter century of history of the Council Committee on Reference Materials of the International Organization for Standardization – REMCO. It begins however with the period before its formation in 1976 to describe how the Committee came into being as a response to a growing need by the analytical community for the number and variety of reference materials (RMs) as well as a need for the assurance of the quality of RMs and ends with a view of REMCO activities in the near future. This is not intended as a detailed history but instead to describe the evolution of REMCO by identifying major activities and accomplishments of REMCO. Received: 21 January 2002 Accepted: 22 January 2002     

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     

Use of ISO Guides 25, 30, 31, 34, 35, and 9001 in re-engineering Bethlehem Steel Corporation's analytical chemistry reference materials program

 Many certified reference materials are needed to calibrate and control analytical measurement processes in integrated steel works. It is beyond the scope and capacity of most national laboratories to supply all of these needs. Yet, the demand for these materials is steadily increasing as more steel producers update their quality systems in preparation for ISO 9000 registration and/or ISO Guide 25 laboratory accreditation assessments. This paper describes how the Bethlehem Steel Corporation updated its reference materials program to meet its internal needs and offers a model for use by others in improving their programs. Received: 22 April 1998 · Accepted: 12 May 1998     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.