scholarly journals Quality management of medical devices. ISO 13485 Implementation Guide

Signos ◽  
2021 ◽  
Vol 13 (2) ◽  
Author(s):  
Javier Ramos Ramos ◽  
Alix Fernanda Cañaveral Rodríguez ◽  
Hernando Camacho Camacho
Keyword(s):  
Quality Management ◽  
Continuous Improvement ◽  
Medical Devices ◽  
Quality Management System ◽  
Theoretical Base ◽  
Competitive Advantages ◽  
Good Manufacturing Practices ◽  
Simple Implementation ◽  
Diagnosis Tool ◽  
Mixed Approach

This research was aimed at creating a methodological guide for the implementation of the quality management system based on the NT ISO 13485: 2016 for medical devices manufacturers, which seeks to share with its readers the parameters necessary for implementing regulatory purposes and convey a perspective on how organizations should apply the standard requirements. The research considered the needs and expectations of organizations in Colombia producing medical devices, evaluated their ability to provide products and services that meet requirements and promote customer satisfaction through continuous improvement. The research starts from a theoretical base that analyzes the application of ISO 13485: 2016 and the requirement of good manufacturing practices in different countries, and the competitive advantages present by exploring the existing literature and the standard requirements. This article results have a mixed approach: quantitative, through the development of a self-diagnosis tool; and qualitative, through a methodological guide development. In each section of the standard, an exposition structure was adopted to facilitate content consultation and compression, thus fulfilling the purpose and applicability aiming to guide a clear and simple implementation.

Quality Management System and Risk Analysis

2022 ◽  
pp. 169-196
Author(s):  
Abdelghani Boudiaf ◽  
Mustapha Zahir
Keyword(s):  
Risk Management ◽  
Food Safety ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Business Leaders ◽  
Competitive Advantages ◽  
Risk Management System ◽  
Risk Approach ◽  
Set Up

Many business leaders believe that a comprehensive risk management system provides an essential foundation for maintaining competitive advantages. Moreover, the company is today in the need to set up this device since its environment is unstable and it is constantly changing. In the current circumstances of the virulent pandemic COVID-19, risk management is gaining importance. The majority of Moroccan companies, especially SMEs, are still in an embryonic stage with regard to the practice of risk management. It should be noted that certain SMEs have set up, in particular in the food industry, a food risk management system since this is of a regulatory nature. The results of empirical research have shown that the implementation of a quality management system or an integrated quality and food safety system in the companies promotes risk management. The risk approach is a transversal approach that allows companies to improve their operation and be resilient.

scholarly journals Factors of quality management system influencing organizational performance: A study of pharmaceutical factories getting GMP certificate in Vietnam

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Nguyen Thuy Quynh Loan
Keyword(s):  
Quality Management ◽  
Customer Satisfaction ◽  
Organizational Performance ◽  
Product Quality ◽  
Product Design ◽  
Continuous Improvement ◽  
Management System ◽  
Quality Management System ◽  
Employee Involvement ◽  
Key Factors

A study objective is to identify key factors of QMS (Quality Management System) influencing the organizational performance in pharmaceutical factories getting GMP (Good Manufacturing Practices) certificate. The original research model consists of eight independent factors (leadership, process management, education and training, supplier management, customer focus, employee involvement, product design, and continuous improvement) and three dependent factors related to organizational performance (productivity, product quality and customer satisfaction). The study collects 265 suitable questionnaires filled by middle managers or the top managers of the pharmaceutical factories getting GMP in Vietnam. The results identify key factors of QMS as leadership, employee involvement towards customer focus, and continuous improvement towards product design have positively impact to organizational performance that is represented by productivity and product quality, customer satisfaction. The study thensuggests managerial implications to top management of pharmaceutical factories in improving performance through enhancing key factors of QMS implementation.

scholarly journals Audit Kepastian Kualitas untuk Menilai Efektivitas Sistem Manajemen Mutu ISO 9001:2008 di UPT Perpustakaan Universitas Jember

2017 ◽  
Vol 4 (2) ◽  
pp. 159
Author(s):  
Septarina Prita ◽  
Jean Suha Theresia Br. Aritonang ◽  
W. Wasito
Keyword(s):  
Quality Management ◽  
Continuous Improvement ◽  
Human Error ◽  
Audit Quality ◽  
Quality Management System ◽  
Iso 9001 ◽  
Management Systems ◽  
Quality Management Systems ◽  
Quality Audit

Library is all about service, therefore UPT Perpustakaan Universitas Jember commited to always do a continuous improvement on their service by implying quality management systems ISO 9001:2008. Tools to evaluate the effectiveness of quality management systems is quality audit which is held by Badan Penjamin Mutu (BPM) and performed annually. Quality audit performed by interviewing respondents, ask the respondents to filling in the questionnaires, and the last method is observing the library activity, and analyzes if the reality meets the standards set by the UPT Perpustakaan itself. There are 3 types of finding resulted by quality audit avtivity, they are cathegorized as observative finding, minor finding and mayor finding. Minor findings have been found in Pembinaan Koleksi's sector and Gugus Penjamin Mutu's sector whilst the mayor findings coming from Sirkulasi's sector, Pengembangan dan Kerjasama's sector and Layanan Perujukan dan Koleksi Khusus's sector. Mayor findings means that management should give more attention to the implimentation of quality management system which is implied to these sectors because the findings can influence the conformity between the processes and the products offered so that those will affect the services's quality given by the library. Minor findings means that finding will not influences the quality of the services, and generally human error is the cause of that findings. But although it will not influences the quality of the services, the minor findings still needs to be documented and need a correction action to correct the findings so that in the future, the management can prevent similar findings to ever occured again.Keywords: ISO 9001:2008, Library, Quality Audit, Quality Management Systems

scholarly journals IMPLANTAÇÃO DO SISTEMA DE GESTÃO DA QUALIDADE EM EMPRESAS PRESTADORAS DE SERVIÇOS DO VALE DO AÇO MINEIRO

2018 ◽  
Vol 4 (1) ◽  
pp. 0035-0041
Author(s):  
Lílian Maria Moreira Lopes ◽  
Sarah De Oliveira Teixeira Cardoso ◽  
Adriana Ferreira De Faria
Keyword(s):  
Quality Management ◽  
Continuous Improvement ◽  
Management System ◽  
Initial Phase ◽  
Quality Management System ◽  
Iso 9001 ◽  
Top Management ◽  
Service Companies ◽  
Definition Of

A busca pela sobrevivência vem fazendo com que as empresas adotem estratégias para se manterem competitivas no mercado, aliado a isso, obter qualidade em seus processos e produtos se torna um fator crucial para as organizações. Dessa forma, tendo ciência da importância da qualidade para a competitividade das instituições, o objetivo desse trabalho consiste em descrever o processo de implantação de um Sistema de Gestão da Qualidade (SGQ), de acordo com os requisitos normativos da ISO 9001:2015 em duas empresas prestadoras de serviços na região do Vale do Aço e evidenciar a importância da participação da alta direção nesse processo. A metodologia utilizada para implantação do SGQ consistiu na definição de seis metas físicas, sendo possível realizar todas as atividades necessárias. O SGQ foi implantado nas empresas, estando em fase inicial de operação e requer grande atenção da alta direção para que as deficiências sejam sanadas e o sistema apresente melhoria contínua.The search for survival has led companies to adopt strategies to remain competitive in the market, along with this, getting quality in your processes and products becomes a crucial factor for organizations. In this way, being aware of the importance of quality for the competitiveness of institutions, the purpose of this work is to describe the process of implementing a Quality Management System (QMS), according to the ISO 9001: 2015 standard requirements in two service companies in the Vale do Aço region and to highlight the importance of the participation of top management in this process. The methodology used for the implementation of the QMS consisted in the definition of six physical goals, being possible to carry out all the necessary activities. The QMS was implemented in the companies, being in the initial phase of operation and requires great attention of the top management so that the deficiencies are solved and the system presents continuous improvement.

scholarly journals Human Resource Management, Total Quality Management and Competitive Advantages: Evidence from Pakistani Banking Industry

2020 ◽  
Vol 4 (1) ◽  
pp. 1
Author(s):  
Syed Waqar Ahmed ◽  
Danish Ahmed Siddiqui
Keyword(s):  
Quality Management ◽  
Strategic Planning ◽  
Total Quality Management ◽  
Performance Appraisal ◽  
Continuous Improvement ◽  
Banking Industry ◽  
Competitive Advantages ◽  
Total Quality ◽  
Cost Leadership ◽  
Hrm Practices

This study aimed to investigate the relationship between human resource management (HRM) practices, total quality management (TQM) practices and competitive advantages in banking industry of Pakistan. HRM practices included Recruitment & Selection, Training & Development, Performance Appraisal, and Compensation & Reward. TQM practices consist of Leadership, Continuous Improvement, Customer Satisfaction, Employee Empowerment, and Strategic Planning. And lastly, competitive advantages is represented by Cost Leadership, and Differentiation. We applied (Obeidat, Yousef, Tawalbeh, & Masa'deh, 2018) model to banking sector of Pakistan. An Adopted questionnaire was designed and distributed over a sample of 300 employees. The research hypotheses were tested by using structured equation modeling. The result shows that Compensation & Reward positively and significantly affect all TQM practices as well as cost leadership. Similarly, Performance Appraisal also produce a significant positive impact on Strategic Planning, and Leadership dimensions of TQM, Hoverer, negatively affect cost leadership. Recruitment & Selection positively affect cost leadership. Strategic planning an importance factor, significantly affect both competitive advantage factors. Interestingly, Training & Development have a significant but negative effect on TQM factors namely Continuous Improvement, Leadership, and Strategic Planning. The findings imply that in banking industry, the effect on HRM factors on TQM is not equal, some are even negative, hence should be used diligently with the prospective of both TQM and competitive advantages.

scholarly journals An Integrated Quality Management System for Healthcare

2017 ◽  
Vol 4 (1) ◽  
pp. 86-92 ◽  
Author(s):  
Els Jonker ◽  
Chantal Koopman ◽  
Natascha van der Nagel ◽  
Marianne Schoorl
Keyword(s):  
Quality Management ◽  
Patient Care ◽  
Continuous Improvement ◽  
Management System ◽  
Quality Management System ◽  
Tracking System ◽  
Hospital Organization ◽  
Continuous Quality ◽  
Internal And External Factors ◽  
Digital Tracking System

Background:A hospital organization with multiple locations and departments is a dynamic organization, which has to deal with a large number of internal and external factors. For the purpose of providing good quality and an effective and efficient patient care, tailored to the actual needs of patients, the focus must be on continuous quality improvement. Therefore, a smart and transparent quality management system for employees and stakeholders is necessary, which is widely accepted in the organization.Method:To realize structure, coherence and easy accessibility of information about ambitions, results, developments and regulations, the Northwest Clinics (The Netherlands) implemented an integrated quality management system, called Northwest:How we Work, including The House with Achievement books and theImprove 2.0App.Results:The House with Achievement books is an instrument for employees, staff and managers to document all agreements that are essential for optimal patient care and management. The House demonstrateswhat you doand the Achievement bookshow you doin your department. In addition, the Improve 2.0 App with a digital tracking system to register points for improvement has been implemented to achieve structure, transparency and coherence in the multiple lists with action points.Employees participate in quality groups to understand the necessity and usefulness of an integrated quality management system, to realize acceptance and to contribute to an environment of continuous improvement.Conclusion:It is concluded that an integrated quality management system meets the criteria of the Plan-Do-Check-Act cycle and a LEAN approach for continuous improvement of quality in patient care and organization development. In addition, the system contributes to a more result-oriented organization.

Sign in / Sign up

Export Citation Format

Share Document