Application of the NIAZ frame of reference; impact on a departmental level

The Netherlands Institute for Accreditation of Hospitals generated a general ”quality standard” applicable to the total quality management of a hospital. In addition departmental standards (NIAZ) are used as a frame of reference within their particular section of the hospitals. So two levels of standards (on an institutional and departmental level) are present and mutually tuned. Both levels can either lead towards a departmental accreditation certificate or a total hospital accreditation certificate. This approach represents a potential that will become extremely important in the future. These various levels should assure and assess their independent as well as joined quality to lead to an overall total quality management system. Various systems applied in Dutch health care, such as NIAZ, EFQM (INK), are discussed. Their use in the hospital setting, the application of indicators and the implications at departmental level are evaluated.     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998     

Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting

Accreditation of healthcare services is recommended to ensure operation according to the highest quality standards. Various initiatives, such as legislation or accreditation by ISO or JCI, may be active to support and improve quality. The growing trend toward JCI hospital accreditation raised the concern of redundancy between JCI requirements for the use of referral laboratories and the ISO 15189 accreditation for medical laboratories. This would result in needless administrative efforts for hospital laboratories to collect and maintain required documentation, as the JCI quality requirements would be guaranteed given that the referral laboratory is ISO 15189 accredited for those examinations. A consensus meeting was organized by the Working Group for Hospital Accreditation of the Belgian Zorgnet-Icuro network, the University Hospitals of Leuven and the Red Cross to discuss the avoidance of any redundancy between both standards and to issue best practice guidelines for referral laboratories. It was concluded that JCI measurable elements for referral laboratories are covered by the ISO 15189 accreditation scope. The article substantiates the consensus that JCI and ISO quality requirements are harmonized and that accurate knowledge and interpretation of prevailing quality standards are essential to avoid redundancy in quality measures.     

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     

Development of a standard for the organization of the interlaboratory comparisons in microbiology of food

The ILAC G13 Guide and the ISO IEC Guide 43-1 are the common, general and horizontal bases for accreditation of providers of proficiency testing and interlaboratory comparisons used by several accreditation bodies. Despite their widespread use, these guides omit specific technical requirements, and sometimes even elements of quality management, clearly defined for the organization of proficiency-testing schemes for microbiology of food. The Sub-Committee 9 “Microbiology of food” of ISO TC34 has created a working group (WG4) to establish a standard detailing such specific requirements for microbiology of food. This technical standard will describe those specific requirements of proficiency testing which organizers of proficiency-testing schemes and any subcontractors must satisfy in addition to the requirements of the ILAC G13 Guide and the ISO IEC Guide 43-1 to achieve accreditation or other recognition.     

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.     

Surveys on the accreditation of providers of proficiency testing and external quality assessment schemes

Two surveys among providers of proficiency testing (PT) and external quality assessment (EQA) schemes were carried out during 2004 and 2005. The main objectives were to explore the current status of accreditation/certification and collect the providers’ views. Information based on the response from 160 providers in 32 countries reveals a strong tendency towards accreditation of PT/EQA. It is shown that this type of accreditation is based on several combinations of normative documents, hence illustrating a lack of harmonisation of national accreditation bodies. The surveys also show that schemes are operated under considerably different conditions and that providers’ competence may or may not be underpinned by other certification and/or accreditation. This paper elaborates on a number of issues related to PT/EQA accreditation, including customers’ views, normative documents, providers’ experience from the accreditation process, views expressed by international organisations, and effects of accreditation on participation fees, quality and availability.     

Establishment of a quality system for nuclear analytical laboratories

Comprehensive Quality Control (QC) and Quality Assurance (QA) Program is stated on the quality policy, organization, methods and records for nuclear analytical laboratories which are necessary for improvement of productivity, to upgrade the performance, credibility and reputation. The proper and complete identification of quality elements for management and technical requirements are being written in Quality Manual as well as analytical and organizational procedures and working instructions according to ISO 17025 standard. Technical ability of gamma, X-ray and a/b laboratories in the Center has been checked by participation in proficiency test, critical technical variables, and quality results. Performance of quality system has been controlled by external audit inspection, progress reports and service to clients. The present study is a framework of the model project of IAEA, coded RER/2/004, which has resulted self-sustainable accreditation from the national body, TURKAK. This revised version was published online in August 2006 with corrections to the Cover Date.     

Current experiences with a quality management system for non-clinical research and development in pharmaceutical industry

Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities. In this business it is of outstanding importance to generate valid data for the assessment of drug development candidates to assure that the huge financial investment, which is based on such assessments, can be successful. Efficacy and safety of products are the final goals of such developments. Therefore, Merck/Merck Serono implemented an additional specifically developed quality management system that covers all areas and locations in Merck Serono Research that were not yet regulated by an existing regulatory quality management system, e.g. GLP (Good Laboratory Practice). The system is known under the name Merck Serono Research-Quality Management System (MSR-QMS). Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company. Furthermore, the implementation process in one specific research department will be highlighted. Using a practical example, the validation of an analytical instrument in a MSR-QMS-regulated research laboratory will be shown and compared to a validation process in a strictly GLP-regulated area. A summary of the experiences with the new quality system will complete this article and the advantages of high quality research results in industry will be discussed.     

A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories

The introduction of quality management systems (QMS) and the accreditation of laboratories according to ISO/IEC 17025 standard are not easy tasks, mainly for those laboratories located at teaching and research institutions. During the implementation of QMS at two testing laboratories of the Federal University of Rio Grande do Sul in Brazil, new solutions to overcome some of the difficulties inherent to this type of environment have been found. The knowledge acquired through this work has led to the proposition of some general steps incorporating a process approach presented in this article, which could be of use to laboratories in their pursuit for accreditation. This proposal suggests the use of strategic planning information, links the QMS objectives to the corresponding processes and sets a few indicators to monitor both performance of and improvements to the system.     

Implementation of a quality management system in a public research centre

In recent decades, it has become increasingly important for public research centres to attract external clients, including government, private and public bodies and companies. They do this by demonstrating their research excellence. A research centre??s ability to provide professional research services can be assessed by competent technical bodies which verify that the research centre??s laboratories operate according to certain predetermined criteria or standards. Although there is no set of generally accepted standards, some regional accreditation bodies already offer accreditation assessment for the R&D laboratories which are in their territory. This article analyses the successful application of a quality management system in a public research centre employing 57 people including researchers, technicians and administrative staff. This system is based on the scheme of regional accreditation of industrial research laboratories which was inspired by ISO 9001:2008 and ISO 17025:2005 and set up by the regional authority. The overall aim of the management system is to monitor all of the industrial research and services which the centre offers to external users, such as government, private and public bodies and companies, and to guarantee that final products, usually technical reports and prototypes, respond to their needs. The accreditation applies to all of the activity of the research centre except for basic research. In this article, the critical factors influencing the success of the implementation of the management system are outlined together with benefits and opportunities. Weak points and problems are analysed, and the actions which were undertaken in order to prevent and manage problems are described.     

How to approach membership of IAF/ILAC Arrangements: the peer evaluation system of IAF and ILAC for single accreditation bodies

Peer evaluation is used by the international accreditation organisations IAF and ILAC as a tool to harmonise the results of accreditation of conformity assessment bodies and as a control mechanism to ensure constantly competent services according to harmonized standards. Upon positive evaluation outcome, the accreditation body may join an Arrangement (MLA/MRA) between accreditation bodies, confirming systematic reliability and competence to the market. The objective of these Arrangements is that they will cover all accreditation bodies in all countries in the world, thus eliminating the need for suppliers of products or services to be certified in each country where they sell their products or services. This article is to aid single accreditation bodies wishing to sign these Arrangements in the future, and, furthermore, to communicate the procedure and the relevance of evaluation to the public in order to build up confidence in such Arrangements.     

The German perspective of using the EFQM model in medical laboratories

The financial resources of health care services are only nominally growing in Germany. Therefore, the politicians have been forced to act. Up to now, a fixed limit of remuneration should not affect the quality of patient management. However, these primary economic issues have initiated positive and negative reactions from the laboratory medicine community. In hospital laboratories the challenge is to realise continuous improvement of service quality but at the same time reduce costs. This can only be achieved by introducing total quality management (TQM) and measuring the quality obtained by the European Foundation for Quality Management (EFQM) model. Predominantly formal attempts to improve quality at the level of ”enablers” such as certification (ISO 9000) or accreditation (EN 45000, ISO 15189) will not solve these problems. Two groups in Germany work on TQM and EFQM: the Working Group ”Laboratory Management” of the German, Austrian and Swiss Societies for Laboratory Medicine and for Clinical Chemistry, and the Institute for Quality Management in Medical Laboratories (INQUAM). Their work has resulted in several books on the subject, successful propagation of application of the EFQM model and a proposal for a formalized ”certification” procedure according to the model.     

Key requirements for introducing quality assurance in measurement laboratories

 The implementation of a quality assurance system is fraught with difficulties. However, these difficulties may be overcome if the laboratory uses suitable means to facilitate the process. It is necessary to mobilise the intelligence and energy of all members of the laboratory. In order to command adherence, the project must be shared, and this necessitates a major effort by all concerned. Communication is a major factor in obtaining the support of all parties. Six important steps must be distinguished: – Defining quality policy – Creating awareness, information, training – Creating a quality structure – Establishing a deadline for obtaining accreditation – Progressive implementation – Experimentation and validation. Even if the task of obtaining and maintaining accreditation remains difficult, it clearly promotes a minimum level of organisation and stepwise progress in quality assurance. The laboratory must keep improving its quality system, using European Standard EN 45001 as an effective management model. Received: 9 April 1997 · Accepted: 11 September 1997     

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.     

Can the new ISO Guide 25/EN 45001 create better confidence in laboratory operations?

 Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process. The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration laboratories is foreseen to come from closer interaction between laboratories and their customers.     

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.     

Quality management in analytical R&D in the pharmaceutical industry: Building quality from GLP

 The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacture practice (GMP). The principles of GLP mainly cover the formal quality aspects of a procedure and do not evaluate the technical aspects in depth. On the other hand, EN 45001 accreditation covers technical performance and is not suitable for pharmaceutical research and development (R&D) as it is almost impossible to comply with the requirements of the European standard in the pharmaceutical environment. The challenge to the pharmaceutical industry is, therefore, to develop quality systems, compatible with GLP principles, that not only cover formal quality items but also ensure good scientific and technical performance. An implementation process focused on real quality improvement is the best way to achieve this objective, culminating in formal recognition of the quality system by third-party assessment. In the case of analytical R&D, the EURACHEM/CITAC Guide CG2 is a very good tool that can help in the definition, analysis and selection of the non GLP quality elements that will be useful. Received: 30 June 1999 / Accepted: 18 October 1999