scholarly journals KAJIAN KESIAPAN LABORATORIUM PUSAT TEKNOLOGI SATELIT LAPAN SEBAGAI LABORATORIUM PENGUJIAN TERHADAP PRODUK SATELIT KUBUS (CUBESAT) SESUAI DENGAN ISO 17025:2017

2021 ◽  
Vol 2020 ◽  
pp. 155-164
Author(s):  
Hogan Eighfansyah Susilo ◽  
Iqbal Vernando
Keyword(s):  
Iso 17025

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

scholarly journals Impactos da implantação de um Sistema de Gestão da Qualidade Baseado em Norma ISO na Cultura de Laboratório no Instituto Nacional de Tecnologia – INT

2012 ◽  
Author(s):  
Nilço Mauro da Silva Moura ◽  
Isabel De Sá Costa ◽  
Denise Medeiros Ribeiro Salles
Keyword(s):  
Iso 17025

Este artigo descreve os efeitos da implantação da Norma ISO IEC ABNT NBR ISO/IEC 17025 na cultura de laboratórios do Instituto Nacional de Tecnologia (INT) e analisa como esta implantação influencia seu modelo de gestão. Como modelo analítico, foi utilizado o Modelo de Ação Cultural Brasileiro formulado por Barros e Prates (1996). O modelo refletiu toda a sua complexidade nas quatro posições definidas: concentração de poder; postura de espectador; personalista; evitar conflito. O foco principal do estudo foi a influência da cultura organizacional no favorecimento ou prejuízo da implantação e manutenção da Norma, bem como suas consequências nos resultados finais;  a pesquisa de campo confirmou a importância das relações entre o gestor e a alta direção e entre o gestor e a sua equipe nesse esforço. Foi utilizada pesquisa descritiva com abordagem qualitativa e estratégia de estudo de caso, utilizando-se entrevistas, documentos e observações diretas. Os sujeitos da pesquisa foram profissionais responsáveis por laboratórios acreditados no INT, com mais de dez anos de experiência na gestão de laboratórios e participantes da implantação da Norma ISO 17025. Palavras-chave: Gestão da Qualidade; Norma ISO 17025; Cultura de Laboratório; Relações Humanas

Grid Technology in Telepatology and Personalised Treatment

2010 ◽  
pp. 117-128 ◽  
Author(s):  
O. Ferrer-Roca ◽  
F Marcan ◽  
ME. Vidal ◽  
E. Ruckhaus ◽  
Roberto Fernández-Baíllo ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Diagnostic Errors ◽  
Grid Technology ◽  
Iso 17025 ◽  
Collaborative Tools ◽  
Relevant Role ◽  
Literature Based Discovery ◽  
Grid Networking ◽  
Personalised Treatment

Histopathology requires automation, quality control and global collaborative tools. Usually the PIMS (Pathology information management system) automates samples, images and reports and progressively incorporates the PI (Pathology informatics), the D-PATH (digital pathology), e-PATH (electronic pathology), the PPH (Patho-pharmacology), virtual autopsy (VA) and all type of translational research in the PMIS. Not being subject to a specific standard, quality control follows ISO-13485:2003 on services and medical devices, ISO 17025:2005 on technical aspects; and ISO-15198:2003 for automate and quantifiable procedures that will be affected by the new European Directive on medical devices. For the non-standardized pathology procedures, consumer’s requirements are what define test and calibration procedures. The paper analysed the non-standardized procedures: VS (Virtual Slides), GRID networking and Literature Based Discovery as tools for knowledge discovery of relevant relationships on image-diagnosis and personalized treatments. Standardized procedures available for search and annotation are the ISO/IEC 11179 Information Technology Metadata Registries specification, the ISO/IEC 13250:2003 for topics maps or MPEG-7 & 21 for images and the ISO/IEC 24800-3 for JPEG query search. The forthcoming innovations prepare to quality certify the so called “solo-pathology” robotic labs, supported by telepathology to reduce diagnostic errors and carrying out a relevant task on personalized treatment through GRID technology. In this environment the JPEG query search play a relevant role on images which metadata can be annotated on natural language.

Preparation of high-accuracy reference gas samples for proficiency testing

2016 ◽  
Vol 56 (2) ◽  
pp. 609
Author(s):  
Damian Smeulders
Keyword(s):  
Natural Gas ◽  
Proficiency Testing ◽  
Calorific Value ◽  
International Standards ◽  
Iso 17025 ◽  
National Measurement Institute ◽  
Mandatory Requirement ◽  
Measurement Results ◽  
National Measurement ◽  
Gas Coal

Participation in proficiency testing is a mandatory requirement for laboratories that are accredited to ISO 17025, as the process of proficiency testing allows quality issues and biases that would lead to wrong measurement results to be identified and corrected. Since 2005 the Australian Government National Measurement Institute has delivered proficiency testing for various forms of natural gas that are produced in Australia, including pipeline natural gas from central and Western Australia, raw natural gas, coal seam gas, coal mine gas, LNG, and feed gas for LNG plants. The gas samples for proficiency testing are manufactured and verified by the National Measurement Institute according to international standards to have the highest levels of accuracy plus international comparability. Participants in natural gas proficiency testing include specialty gas companies, refineries, pipeline operators, gas producers, LNG plants, and independent gas testing laboratories. Many companies have a long history of participation that demonstrates continual improvement in the accuracy of their measurement results. This extended abstract gives an insight into the present state of the measurements of composition and calorific value of natural gas, and whether the measurements meet the international benchmarks for accuracy for LNG export. In addition, the extended abstract details the manufacture of the gas samples, and how proficiency testing studies operate, as well as examples where companies have improved their measurement performance across time.

Qualification of Pumps and Valves for the Safety Injection Path of Nuclear Power Plants

2014 ◽  
Author(s):  
Ingo Ganzmann ◽  
Holger Schmidt
Keyword(s):  
Nuclear Power ◽  
Power Plants ◽  
Critical Factor ◽  
International Organization ◽  
Insulation Material ◽  
Hydraulic Test ◽  
Iso 17025 ◽  
Operation And Maintenance ◽  
Related Plant ◽  
Construction Operation

The reliability of a nuclear power plant depends on the safe functioning of its components during its lifetime: from design through construction, operation and maintenance. This is valid for new build projects as well as for the current fleet. As plants undergo modifications for increased performance or extended lifetimes, component integrity becomes a critical factor in those efforts, particularly for safety-related plant functions. This paper focuses on the qualification of pumps and valves of the safety-injection path, considering new requirements. Going back to the Barsebäck event in the year 1992, it is known that insulation material may cause clogging. Consequently, the presence of debris material in the water may have an impact on the functioning of pumps and valves. For this purpose, AREVA has built new thermo-hydraulic test loops in its accredited test and inspection body (according to International Organization for Standardization (ISO) 17025 and 17020) to consider this effect as it relates to components qualification (Ref. 1). The main relevant aspects of these tests will be discussed together with corresponding thermal shock tests. Paper published with permission.

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