International Organization for Standardization ISO 9001:1994 Quality Systems — Model for Quality Assurance in Design, Development, Production, Installation and Servicing

2020 ◽  
Vol 26 (1) ◽  
pp. 44-47
Author(s):  
John Michael Collins

This is the second article in a two-part series that proposes how healthcare organisations could implement a quality assurance approach based on the requirements of a thus far unwritten healthcare modification of the 2015 International Organization for Standardization (ISO 9001). This second article will address the issue of unexpected failures of manufactured medical implants and medication delivery devices. Issues facing the quality assured supply of medical equipment, as well as the failure of implants during fitting or use and the failure or malfunction of powered syringes or drips, is discussed. At the end of the article, a list of self-audit questions is proposed to allow readers to make an assessment of how their own organisation has responded to the failure of medical implants or devices in the past, and whether action has been taken to prevent any problems reoccurring.


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.


DEDIKASI PKM ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. 101
Author(s):  
Aria Aji Priyanto ◽  
Ali Zaenal Abidin ◽  
Gina Fauziah ◽  
Heri Saputra ◽  
Juwita Ramadani

The purpose of community service activities is to provide information about ISO (International Organization for Standardization) to the employees of PT. Tegnolabindo in developing good human resources at the company. The method of service is the method of seminar, discussion and question and answer as well as personal evaluation. The ISO material presented is ISO 9001: 2015. The results of information activities about ISO (International Organization for Standardization) to employees of PT. Tegnolabindo, employees are expected to have knowledge about ISO and how it is implemented. Furthermore, in order to be applied in the company, especially in improving good human resources in the company.Keywords: ISO, Human Resources


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