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.     

Management review checklist for ISO/IEC 17025 and ISO 15189 quality-management systems

Management reviews are key processes in many quality-management systems, including laboratory-management systems, in accordance with ISO/IEC 17025 and ISO 15189. These reviews are fine opportunities to understand and manage all the inputs and outputs of a quality-management system. Laboratories often meet some difficulties fully exploiting the management-review process because either they do not realize the importance of this process or they do not have the experience to run this process in a way producing the intended results. This work presents a management review checklist which helps laboratories carry out an effective management review going through all the important aspects of the quality-management system.     

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.     

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.     

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.     

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.     

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.     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.

     

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     

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     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.     

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     

Risk-based thinking for chemical testing

Accreditation and Quality Assurance - As a result of the changes to the ISO 9001 in 2015, integration of risk-based thinking into the quality management system is going to be a new requirement in...     

Quality assurance in research laboratories

During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.     

Quality assurance and instrumentation

 The quality process for commercial analytical equipment starts with the selection of the vendor. It is recommended that vendors be selected who are recognized as having quality processes in place for instrument design, development, manufacturing, testing, service, and support, for example, ISO 9001 registration. When the instrument arrives in the laboratory, the installation process should follow well-documented procedures. This includes a visual inspection that the instrument is not damaged and checking that the instrument, documentation and accessories such as cables and tubings are complete. Before the instrument is used it should be verified that it meets functional and performance specification. During operation the instruments should be periodically inspected and tested, verified to meet performance, and calibrated. The instrument should be labeled with the calibration status, indicating the dates of the last successful and the next performance verification and calibration. Defective instruments should be removed from the testing area or should at least be labeled as being "out of order." Received 23 August 1995 Accepted 6 September 1995     

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     

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.     

Quality management systems in radiochemistry and radiopharmacy — applications in academy and industry

Except the nuclear fuel reprocessing and nuclear materials safeguards, at present there are two areas of an increased responsibility of nuclear scientists for their results: radioecology and human medicaments. At both of them, quality and trustfulness of results is of great importance for their end-users and may have serious economical and legal consequences. The trends of implementation of good laboratory and manufacturing practices under umbrella of international quality management standards like ISO 17025:2005 and ISO 9001:2000 in radiochemical and radiopharmaceutical laboratories are discussed as expanding to “good scientific practice”. The case studies of the Comenius University laboratory LARCHA authorized for radiochemical analysis, and the company BIONT producing medical radionuclides and PET radiopharmaceuticals are used as the examples.     

Quality assurance in research: incorporating ISO9001:2000 into a GMP quality management system in a pharmaceutical R+D+I center

There is currently no universal or standardized quality system for the recognition of excellence of a research center. Knowledge and competence may not be enough in the current rapidly changing world in which high productivity and continuous improvement are essential. The purpose of this study was to assess the impacts of implementing the ISO9001:2000:2000 standard in an academic research center dedicated to R+D+I (research, development and innovation) in the pharmaceutical industry. The article describes the stages we followed to implement the ISO9001:2000 system, which was achieved by integrating it into the previous regulatory system of GMP (Good Manufacturing Practices). As a result of implementing ISO9001:2000, the center has seen distinct improvements, such as fewer errors in project documentation, improved assessment of customer satisfaction, and the effective implementation of periodic plans, e.g., in calibration, preventive maintenance, and investments. Overall, ISO9001:2000 implementation has been beneficial for the organization and could be applied to other research centers.     

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.