The effect of implementation of the ISO 9000 on customer complaints; a 5-year follow-up study in a regional laboratory.

Although the importance of quality management in the medical laboratory has been emphasized, we are unaware of any interventional studies demonstrating benefits of implementation of recommendations of the International Standards Organization (ISO). In the following 5-year follow-up study, we implemented quality management as stipulated by the ISO, received a certificate of approval, and determined how the program affected customer complaints. From 1997 to 2001 there was only a slight decrease in the number of customer complaints, but a significant continuing downward trend in the proportion of justified complaints (chi-squared test, p<0.001). In fact in 2001 the proportion of justified complaints had decreased by nearly 80% (relative risk, 0.22; 95% confidence interval, 0.09–0.52)), to only 10.9% of the total complaints. We conclude that the use of the ISO 9000 along with good laboratory practice resulted in a significant decrease in the proportion of justified complaints.     

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.     

Validating automated analytical instruments to meet regulatory and quality standard requirements

Analytical laboratories are more and more faced to meet official regulatory requirements as described in FDA and EPA good laboratory practice, good automated laboratory practice and good manufacturing practice regulations or to officially establish quality systems, such as specified in the ISO 9000 Series quality standards, in the ISO Guide 25 or in the EN 45001 guidelines. The impact on analytical instrumentation will be the requirement for stringent validation of analytical equipment and methods which increase the overall analysis costs. An overview is presented on the validation requirements using e.g. gas chromatography, high performance liquid chromatography, capillary electrophoresis and UV-visible spectroscopy and on the strategy to meet such needs at minimal extra costs with the help of an instrument vendor. It is recommended to use instrument hardware that has already built-in tools for self-verification and which is to be validated at the vendor's site. Performance testing in the user's laboratory is done using standard operating procedures as supplied with the instrument. If resources in the user's laboratory are limited, the performance verification is done by the vendor. Software and the entire computer system is validated prior to shipment at the vendor's site. Acceptance testing is done in the user's environment following the vendor recommendations. Analytical methods are validated automatically at the end of method development using a dedicated software. The software can be customized such that it can also be used for daily automated system suitability testing. Security and integrity of analytical data are ensured by saving the raw data together with instrument conditions and instrument log-books in check-sum protected binary register files for long-term archiving.     

Standardization of quality management in the medical laboratory

A new ISO standard (ISO/DIS 15189) on quality management in the medical laboratory is being prepared. The origins and development of this in ISO and the interaction by CEN in Europe is presented. The major comments already received are given as well as the likely progress of this ISO standard. Once published it will have implications for accreditation of medical laboratories throughout the world and particularly those in Europe.     

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.     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

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     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

Quality assurance in analytical chemical laboratories: Towards harmonization and integration of current standards

This article presents the results of a comparative study of the main quality assurance (QA) and good laboratory practice (GLP) regulation systems and standards for analytical chemical laboratories currently being applied in Europe. A growing number of laboratories are being confronted with the need to cope with two or more of these systems, which involves separate audits and inspections for certification and accreditation. As these regulatory systems have essentially the same aims, there is an increasing interest in harmonization of QA and GLP guidelines. As a first step in exploring the possibilities of harmonization, similarities and differences of the current systems, compiled in the form of cross reference tables, have been analyzed (from a laboratory practice point of view) by a study group of EURACHEM, The Netherlands. The conclusions of this study have recently been endorsed by the Committee of EURACHEM Europe.     

Establishment of a quality system at the Nuclear Analytical Laboratories of the Atomic Energy Authority, Sri Lanka

A quality system according to the requirements of ISO/IEC guidelines has been introduced at the Nuclear Analytical Laboratories of the Atomic Energy Authority, which has received appreciation from International Atomic Energy Agency (IAEA) inspection evaluation reports (RAS/2/010) showing a positive indication to accreditation. The quality system has achieved the “analytical quality” through technical competence by non-conformance management. The experience in the progression towards achieving a quality system is described with examples from zero level to a positive index. This nuclear analytical service laboratory shows long-term stability of performance and enhances its credibility to customers, through the quality system.     

加强实验教学环境内涵建设 提高环境育人质量

在实验室里的实验教学过程涉及到教书育人、管理育人、服务育人和环境育人。一个良好的实验环境不仅能够对学生起到潜移默化的教育作用,而且对教书育人、管理育人和服务育人工作的开展和实施也能起到推动和促进作用。本文主要介绍厦门大学化学国家级实验教学示范中心"以学生为中心",在强化实验教学环境内涵建设、提高实验环境育人质量方面的一些做法和体会,以期更好地为实验教学"思政"提供可复制、可推广的建设方案。     

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-d-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system??s GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.     

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.     

Problems of validation of computerised instruments for accredited chemical laboratories

 Some problems of validation of computerised instruments are reviewed briefly, taking essential standards and guides into account. The significant role of certified standard reference materials is underlined. An attitude of suppliers towards the validation of instruments is presented, and producers' responsibilities and obligations are discussed. The "black-box" concept is recommended as a preliminary step for the validation of computerised instruments. Two examples for gel permeation chromatography are given that illustrate a bad manufacturer's practice (BMP) and good manufacturer's practice (GMP). In the case of BMP, a need is expressed for a guide and for regulations that should be implemented into the quality assurance system. It has been proposed that the EURACHEM/VAM draft of guidance for qualification/validation of instruments should be amended by incorporating the "black-box" approach as a preliminary procedure for validation of computerised instruments, a retrospective validation procedure if the need for current validation was not foreseen or not specified, and a procedure (or selection rules) for qualification of the supplier. Moreover, the mechanisms of inspection to control the observance of the standardised rules and commonly recognised recommendations should also be considered by international quality organisations. Received: 19 November 1996 · Accepted: 20 March 1997     

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.     

Quality assurance in forensic toxicological analysis

 In this paper, we review the work done in forensic toxicological analysis during about the last 30 years in Europe and to some extent in other parts of the world to assure the quality of toxicological investigations. Guidelines for carrying out toxicological analyses set up by professional bodies in the United States (AAFS/SOFT), Europe (GTFCh) and worldwide (TIAFT) are mentioned, and the problems of complying with the regulations set up in EN 45 000/ISO 9000 are discussed in detail. There are still diverging opinions as to whether toxicological laboratories should comply with good laboratory practice or with EN 45 000, and, as fas as Germany, Switzerland and Austria are concerned, a working group of the GTFCh is discussing which procedure should be adopted. Apart from having this discussion, the group aims to standardize suitable methods and is planning the organization of suitable round robins. Received: 18 December 1995 Accepted: 11 April 1996     

Implementation of ISO 9001 in a medical testing laboratory

 The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales, Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services, it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper describes the Quality System that the Department developed and which has been successfully maintained and extended since original certification. Important features of the Quality System are: 1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements. 2. Use of national Quality Award criteria to identify key business processes. 3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective action procedures. 4. Implementation without external resources. Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process. However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible when this process is undertaken at the level of the entire organisation. Received: 9 September 1996 Accepted: 5 October 1996     

Compliance with GLP standards and management in analytical laboratories: current status

 Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility. The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method, laboratory information management, and security systems. The differences in the responsible authorities and scopes under the six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals. Received: 27 September 1996 Accepted: 11 November 1996