Certificaciones, ISO 9001 y auditorías de calidad

2014 ◽  
Vol 9 (17) ◽  
pp. 71-92
Author(s):  
Ricardo Adolfo Parra Huertas
Keyword(s):  

La ISO 9001 es una herramienta universalmente aceptada como modelo de sistema de gestión de la calidad. Mediante la implantación de la norma ISO 9001 la empresa desarrolla su Sistema de Gestión de la Calidad, el cual se define como el conjunto de la estructura organizativa de la empresa, los procedimientos, los procesos (de producción y de gestión) y los recursos necesarios para asegurar la Gestión de la Calidad. La implementación de la ISO 9001 puede ser evaluada a través de auditorías que son procesos sistemáticos e independientes documentados para obtener evidencias con el fin de determinar el alcance del sistema. Para constatar la implementación del sistema de calidad se lleva a cabo un proceso de certificación por una entidad acreditada como independiente de las partes acreditadas, manifestando por escrito que un producto, proceso o servicio debidamente identificado es conforme con una norma o documento normativo como la ISO 9001.

2001 ◽  
Vol 40 (06) ◽  
pp. 228-238 ◽  
Author(s):  
U. Paschen ◽  
S. Kröger ◽  
K. H. Bohuslavizki ◽  
M. Clausen ◽  
V. Jansen-Schmidt

SummaryIn 1995, the management of the University Clinic Hamburg-Eppendorf proposed to establish a total quality assurance (QA) system. A revised QA-system has been introduced stepwise in the department of nuclear medicine since 1997, and certification was achieved in accordance with DIN EN ISO 9001:2000 on February 14,2001.The QA-handbook is devided into two parts. The first part contains operational (diagnostic and therapeutic) procedures in so-called standard operating procedures (SOP). They describe the indication of procedures as well as the competences and time necessary in a standardized manner. Up to now, more than 70 SOPs have been written as a collaborative approach between technicians and physicians during daily clinical routine after analysing and discussing the procedures. Thus, the results were more clearly defined processes and more satisfied employees.The second part consists of general rules and directions concerning the security of work and equipment as well as radialion protection tasks, hygiene etc. as it is required by the law. This part was written predominantly by the management of the department of nuclear-medicine and the QA-coordinator. Detailed information for the patients, documentation of the work-flows as well as the medical report was adapted to the QM-system. Although in the introduction phase of a QA-system a vast amount of time is necessary, some months later a surplus for the clinical workday will become available. The well defined relations of competences and procedures will result in a gain of time, a reduction of costs and a help to ensure the legal demands. Last but not least, the QA-system simply helps to build up confidence and acceptance both by the patients and the referring physicians.


2018 ◽  
Vol 13 (Number 2) ◽  
pp. 67-77
Author(s):  
Anis Syamimi Abd Rahim ◽  
Mohd Norhasni Mohd Asaad

The purpose of this study is to review the implementation of ISO 9001:2015 in order to improve the quality of services at Pusat Kesihatan Universiti (PKU), Universiti Utara Malaysia. The respondents of this study were customers at the PKU, UUM. The questionnaire was distributed to 50 respondents. The data were analyzed using SPSS software version 24. The data were tested using descriptive statistics, and correlation analysis to answer the research questions and to achieve the objectives. The findings show that customers agree that implementation of ISO 9001:2015 give service at PKU, UUM is good and satisfied. Through the correlation test, the results showed that the relationship between the implementation of ISO 9001:2015 has a positive and significant impact on customer satisfaction and the effect of implementing ISO 9001:2015 has a positive and significant impact in improving quality of service at PKU, UUM.Through mean and standard deviation tests, results show that tangible dimensions are the main dimensions of customer satisfaction while dimensions with low values are dimensions of responsiveness.Therefore, all aspects of service in PKU, UUM will be strengthened and all aspects of the weaknesses could be addressed to improve the service in order to maintain good quality services.


2004 ◽  
pp. 23-26
Author(s):  
RomualdI. Zalewski ◽  
Michał Borucki
Keyword(s):  

W tej części artykułu przedstawiono wyniki badania satysfakcji klientów korzystających z usług doradczych wyspecjalizowanej firmy uzyskane zmodyfikowaną metodą SERVQUAL. W badaniu oceny jakości usług wzięło udział 50 klientów. Dowiedziono, że badanie satysfakcji klienta oparte na metodzie SERVQUAL jest przydatnym narzędziem do doskonalenia Systemu Zarządzania Jakością zgodnego z normą ISO 9001:2004.


2014 ◽  
Vol 2 (3-A) ◽  
Author(s):  
Carlos Eduardo Borges Queiroz ◽  
Walmoli G. Júnior ◽  
Tiago Jahn ◽  
Tiago Hahn ◽  
Thiago Fontana ◽  
...  
Keyword(s):  

2018 ◽  
Vol 4 (3) ◽  
pp. 19-42
Author(s):  
Keliany Marçal Silva ◽  
Juliana Luíza Moreira Del Fiaco

A implantação das normas aplicadas pela ISO (International Organization for Standardization) pode ser benéfica ou não para as organizações, dependendo da forma como são aplicadas. Este artigo fruto de pesquisa analisou se a Associação Comercial e Industrial de Anápolis (ACIA) aplicou bem o Sistema de Gestão da Qualidade (SGQ) e assim teve como objetivo geral identificar possíveis prós e contras da implantação da ISO no trabalho cotidiano dos seus colaboradores internos, e por, objetivos específicos: relatar como os colaboradores da ACIA entendem e utilizam a ISO; caracterizar as melhorias no trabalho interno dos colaboradores pós implantação do SGQ e avaliar as melhorias que o SGQ provocou na instituição. Para atingir tais metas, realizou-se uma pesquisa descritiva, explicativa e bibliográfica, sendo necessário entrevistar os colaboradores por meio de aplicação de questionários para 22 sujeitos da pesquisa, que revelaram conforme os resultados apresentados a seguir, que estes não veem a participação necessária da gestão nos quesitos relacionados à NBR ISO:9001 que está implantada na empresa e precisa de manutenção constante, porém, acreditam que quando bem controlado, o sistema pode gerar economicidade, organização e padronização, sendo benéfico para o trabalho rotineiro.


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