Quality assessment in a Brazilian laboratory performing k0-NAA

This work is focused at the demonstration of the overall adequacy of the procedures introduced in a Brazilian laboratory for conducting the k ₀-standardized NAA. Concentrations of 29 elements determined in certified reference materials of plants and geological matrices are evaluated. Most of the experimentally determined values agreed well with the reference data and no consistent bias could be attributed to the analytical system adopted.     

Step-by-step implementation of a quality system in the laboratory

In recent years laboratories have undergone huge transformations due to the technological development of inspection and testing equipment; the introduction of computerised and automated systems; keen competitiveness between companies/laboratories as a result of demand within Europe and on the international market; and greater consumer awareness of the quality of the products available. Laboratory accreditation, though a voluntary process, is formal recognition by an accreditation body of the laboratory's competence to carry out certain tests. This article presents those aspects which should be taken into account in the step-by-step implementation of a quality system and also makes reference to the requirements for the operation of accredited laboratories in accordance with European Standard EN 45001.     

The implementation of accreditation in a chemical laboratory

This article describes the current state of the art in the accreditation of chemical laboratories, both in Europe and world-wide, emphasising the most common discussion topics. The results of recent proficiency testing in chemical laboratories are summarised to draw conclusions on the performance of accredited laboratories.     

Utilisation of customer feedback in a university hospital laboratory

The article describes the customer feedback system at a university hospital laboratory and the analysis of the feedback data from clinical customers in 2001–2006. The most common subject matters of the feedback were suspicion of the validity of laboratory results, delay in service and lacking test results, covering 82% of the 115 reports. The investigations of the cases revealed errors or defects in laboratory services in 81 cases. The most common errors or defects were erroneous test results (35 cases; 43%), delayed test results (24 cases; 30%) and lacking test results (15 cases; 18%). The most common underlying causes for a laboratory error or defect were unintended errors and non-compliance with operating instructions. Seventy-six percent of the feedback reports led to corrective actions. It is important to react to every instance of customer feedback and to find out possible errors or defects in the laboratory process. Uncovering the underlying causes makes adequate corrective and preventive actions possible.     

Quality system implementation in Member States of the IAEA

The International Atomic Energy Agency (IAEA), through its Technical Co-operation Programme, has supported the establishment of many nuclear analytical and complementary laboratories in Member States. This included the development of capabilities for the use of various nuclear analytical techniques that include alpha, beta, and gamma spectrometry; radiochemical analysis; neutron activation analysis; energy dispersive X-ray fluorescence analysis; and total reflection X-ray fluorescence. As economic, ecological, medical, and legal decisions are frequently based on laboratory results, they need to be based on accepted national and international standards.The IAEA has taken up this important issue to enhance and foster the competitiveness of nuclear analytical laboratories with the consideration that non-nuclear capabilities are equally important. The projects aim at enhanced quality awareness, a concise system for documentation, establishment of standard operating procedures, procedures for validation of methods, surveillance of method performance, systems for sample management, regular qualification of personnel, client liaison and safety. These projects follow the ISO/IEC 17025 standard and promote participating laboratories to maintain a self-sufficient quality system by which they might be able to obtain national accreditation.This contribution describes the general concept of these projects and discusses some of the results achieved.     

Quality system implementation in the National Metrology Institute of Montenegro

Accreditation and Quality Assurance - Accreditation of calibration laboratories is a means for achieving competence recognition and assuring customers that their calibration services are accurate...     

Plans for implementation of a quality system in the control laboratory of the Romanian National Medicines Agency

This paper describes the practical implementation of a quality system in the control laboratory of the National Medicines Agency, Romania, the main aim being the alignment of the requirements of the control of drugs in Romania with European Union standards. Activity in this field is relatively new in Romania, however, it is of great importance to Romania’s compliance with international standards. Received: 13 September 2000 Accepted: 19 February 2001     

Reacting to spontaneous feedback from external customers in a university hospital laboratory

Modern quality standards for laboratories recommend the use of customer feedback in quality improvement. Spontaneous customer feedback is one method to obtain information from customers. In the present study, we analysed the feedback data from external customers (health centres and other hospitals) to our university hospital laboratory during 2001–2006. The most common subject matters of the feedback, covering 87% of a total of 95 reports, were lacking test results, suspicion of the validity of test results, return of samples in transportation boxes to customers and delays in service. On investigation, errors or defects were revealed in 78 cases. The most common errors were lacking (45 cases; 58%), erroneous (20 cases; 26%) or delayed test results (7 cases; 9%). As much as 68% of these errors took place in the pre-analytical phase of the laboratory process, occurring most commonly during specimen transfer, when entering orders into the laboratory information system at the university hospital or during sample processing. The most common underlying causes for errors were unintended errors and non-compliance with operating instructions. Latent errors were identified in 14% of the cases. Corrective actions were performed in 79% of the reported cases. It is important that the feedback reports are investigated to find out possible errors and their underlying causes so that appropriate corrective actions can be taken. When processed properly, spontaneous customer feedback is a method that can be used supplementarily to other methods to detect errors and defects in clinical laboratories and to aid in quality improvement.     

ISO 17025 quality system in a university environment

The experience of working under an ISO 17025 compliant quality system in a university environment is described in the example of the Testing Centre of University of Tartu. University-specific features of the quality system include that the Testing Centre acts as the “quality system server” for other units of the university and graduate students participate in the work carried out under the quality system. The benefits for the university and the graduate students are discussed. It is concluded that implementation of an ISO 17025 compatible quality system in a university is fully accomplishable and gives significant added value to the university by helping to destroy the ivory tower perception about universities and by introducing real-world flavour into the studies and broaden the minds (quality awareness) of the students.     

Implementation of a quality system in a clinical laboratory

The effects of a quality system are measured with the aid of quality indicators, which can be used for both decision-making by the management of the laboratory and for process control. The need for economic appraisal is stressed since the development of a quality system is very time- and labour-consuming. The aspects of both the customer and the personnel involved should be considered to evaluate the quality system. It is also important to define practical means to build up and maintain a quality system especially in smaller laboratories. For instance, simple tools to evaluate uncertainty of measurement and availability of inexpensive national reference materials are needed.     

Quality in clinical laboratory measurements

 Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international, regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results from clinical laboratories.     

Improving laboratory economic and environmental performance by the implementation of an environmental management system

Accreditation and Quality Assurance - The RCPAQAP is a medium-sized healthcare organisation with a laboratory, logistics and office area. The organisation begun integrating an environmental...     

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     

Quality assurance in the microbiology laboratory

 The pertinent issues necessary for the establishment of quality assurance in the microbiology laboratory are discussed. Quality assurance is a planned system of control measures that enables management to ensure that the analytical data produced in the laboratory are valid. To introduce quality assurance, all activities in the laboratory that affect the production of analytical data must be documented and controlled. These include sampling, method selection, laboratory environment, equipment, reagents and media, staff, reference materials and internal and external quality control. Laboratory accrediation in accordance with EN45001 and ISO Guide 25 enables laboratories demonstrate to an external agency their ability to perform analytical work and produce valid analytical data. This gives creditability to the laboratory and allows management to have confidence in the data produced. Received: 6 June 1995 Accepted: 3 July 1995     

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.     

Computer system for a small analytical research laboratory

A solution to three problems concerning computer use in our laboratory is described. The problems are: replacement of obsolete computer equipment, consolidation of data processing programs, and unification of the format of kinetic data from different sources. The solution involves use of a central super microcomputer with personal computers used primarily for data acquisition and temporary storage.