ANALYSIS OF THE RISK MANAGEMENT PROCESS IN THE QUALITY MANAGEMENT SYSTEM OF AN ENTERPRISE MANUFACTURING MEDICAL DEVICES

2020 ◽  
pp. 49-55
Author(s):  
T. A. Lartseva ◽  
O. V. Aleksashina ◽  
E. V. Pak ◽  
O. N. Grinyuk
Keyword(s):  
Risk Management ◽  
Quality Management ◽  
Medical Devices ◽  
Management System ◽  
Quality Management System ◽  
Management Systems ◽  
Management Process ◽  
Process Scheme ◽  
Market Conditions ◽  
Risk Management Process

In modern market conditions, any organization, including those engaged in the production of medical devices, must identify risks, carry out their analysis, and determine the degree of their influence on the achievement of goals. This forces enterprises, on the basis of standards for management systems, standards for risk management, including taking into account the specifics of organizations, to implement a risk-based approach, creating their own risk management mechanisms. The article presents and describes in detail the basis for the methodology of the risk management process scheme in the quality management system of an organization engaged in the field of medicine.

scholarly journals Adaptation of the Risk Management System in an Industrial-Type Enterprise

2021 ◽  
Vol 19 (3) ◽  
pp. 134-141
Author(s):  
N. N. Vasilyeva ◽  
◽  
A. V. Svinov ◽  
O. V. Tkachuk ◽  
◽  
...  
Keyword(s):  
Risk Management ◽  
Management System ◽  
Quality Management System ◽  
Quantitative Risk Assessment ◽  
Management Process ◽  
Business Results ◽  
Risk Management System ◽  
Risk Management Process ◽  
Iso 31000 ◽  
Qualitative Risk Analysis

Today, little attention is paid to risks, with management focusing more on performance indicators and business results than on analyzing dangerous situations and finding new opportunities. The risk management system proposed in this paper will help to take risks under control and systematize the risk management process. Ideally, it should be integrated into the quality management system. The paper also provides a study on the development of methods for identifying, analyzing and assessing strategic risks. The risk management process is described in accordance with GOST R ISO 31000-2019; methods of risk management are considered. The risk management system included a register, a questionnaire, criteria for the severity of risk and the likelihood of occurrence, as well as a matrix of risks with a description of its zones and levels of risk. The paper provides a procedure for risk management, which describes the stages of the risk management process and their relationship with the approach proposed in GOST R ISO 31000. The standard questions of the questionnaire are formulated that will help simplify the process of identifying risks in the enterprise if the manager does not have a certain plan. A form of a risk register is proposed, which consists of successively filled columns: strategic goal, risk, qualitative risk analysis, quantitative risk assessment, risk reduction. It also describes how to fill it out and its main functions. Thus, the entire risk management system is described through its separate, but interconnected parts. With a competent approach and the integration of RMS into the QMS, risk management will give a tangible effect.

Quality Management System and Risk Management System: Similarities and Possibilities for Integration

2014 ◽  
Vol 564 ◽  
pp. 700-705 ◽  
Author(s):  
Mahmoud Asad Samani ◽  
N. Ismail ◽  
Z. Leman ◽  
N. Zulkifli
Keyword(s):  
Risk Management ◽  
Quality Management ◽  
Management System ◽  
Cultural Context ◽  
Quality Management System ◽  
Integrated Management ◽  
Management Systems ◽  
Risk Management System ◽  
Main Driver ◽  
Quality Of Products

Today organizations are required to deal with and manage a variety of challenges in their day-to-day activities. Examples of these challenges are issues related to quality of products/services, environment, employees’ safety and health, corporate social responsibilities, risks and many others. In response to these challenges, several Management Systems (MSs) and Management Systems Standards (MSSs) have been introduced in recent years to systematically guide an organization to cope with these challenges. The need to create Integrated Management System (IMS) is the result of increase in the number of these MSs and MSSs. There are also evidences in literature and practice that organizations have slowly started to tackle the IMS issue. The journal papers’ related to MSs Integration field, highlight that in theory any two MSs or even more are potentially capable of being integrated. In this study, it will be shown that the attitudes and approaches behind the two important function-specific MSSs developed by ISO Organization, i.e. Quality Management System (QMS) and Risk Management System (RMS) are largely similar and complementary. Hence, the integration of these two MSs seems justifiable. The main driver for such integration is to reduce the number of MSs in an organization and hence to decrease the number of resources employed. Also it will be demonstrated that the integration of these two MSs will result in more significant background, cultural context, techniques, procedures and synergy to an organization.

Gestión de riesgos empresariales: los necesarios cambios

Oikos ◽  
2016 ◽  
Vol 19 (39) ◽  
pp. 93 ◽  
Author(s):  
Ricardo Vega Bois
Keyword(s):  
Risk Management ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9000 ◽  
Management Control ◽  
System Requirements ◽  
Requirements Quality ◽  
Management Recommendations ◽  
Environmental Audits

RESUMENLa normas de la serie ISO 9000 – 2000, Sistema de Gestión de Calidad, Requisitos de un Sistema de Gestión de Calidad, Recomendaciones para la mejora de desempeño en base a un Sistema de Gestión de calidad y Directrices para la realización de auditorías medioambientales y de calidad, han sido base para la evaluación, implementación, aplicación y seguimiento de sistemas de Control de Gestión Empresarial, estando en la actualidad (2015) en un procesos de revisión y propuesta, lo que implicará algunos cambios de forma y otros de fondo interesantes de considerar.Palabras clave: gestión, riesgos, control de gestión, calidad, normas internacionales.Enterprise risk management: the necessary changesABSTRACTThe standards ISO 9000 - 2000 Quality Management System, System Requirements Quality Management Recommendations for improving performance based on a Quality Management System and Guidelines for conducting environmental audits and quality have been the basis for evaluation, implementation, enforcement and monitoring systems Control Management, being at present (2015) in a review and proposal processes, which involve some changes in form and other interesting background consider.Keywords: management, risk, management control, quality international standards.Gestão de riscos empresariais: as mudanças necessárias RESUMO As normas da série ISO 9000-2000, Sistema de Gestão da Qualidade, Requisitos de um Sistema de Gestão de Qualidade, Recomendações para a melhora do desempenho com base a um Sistema de Gestão da Qualidade e Diretrizes para a realização de auditorias meio ambientais e de qualidade, têm sido a base para a avaliação, implementação, aplicação e fiscalização de Sistemas de Controle de Gestão Empresarial, sendo na atualidade (2015) num processo de revisão e proposta, que implicará algumas mudanças na forma e outros de fundo interessante de considerar.Palavras-chave: gestão, risco, controle de gestão, qualidade, normas internacionais.

scholarly journals Profitability and leverage in eco-efficiency and quality management system for increasing the firms’ performance

2020 ◽  
Vol 22 (3) ◽  
Author(s):  
Budiman Sutrisno ◽  
Wendy Wendy
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Stock Exchange ◽  
Multiple Linear Regression Model ◽  
Moderating Effect ◽  
Management Systems ◽  
Moderating Effects ◽  
Quality Management Systems ◽  
The Relationship

This research aims to analyze the moderating effects of profitability and leverage on the relationship between the quality management system and eco-efficiency toward the firm’s performance. The research sample consists of 75 firms listed on the Indonesia Stock Exchange as of 2017. Data concerning eco-efficiency and the quality management system are collected from the firm's annual report. This research utilizes a multiple linear regression model. The result shows that eco-efficiency and quality management system do not affect the firm’s performance. Profitability has a negative and significant moderating effect on the relationship between eco-efficiency toward the firm’s performance. Further, the moderating variable also positively and significantly moderates the relationship between the quality management system and the firm's performance. Leverage, on the other hand, is found to have no moderating effect on the relationship between eco-efficiency and quality management systems toward the firm's performance.  This study contributes and extends previous research by exploring eco-efficiency and quality management systems toward the firm’s performance simultaneously. Besides, it also examines the moderating relation of profitability and leverage in relationship with eco-efficiency and quality management system toward a firm's performance by using the sample from all firms which are listed on the Indonesia Stock Exchange and have implemented the system.

Development of the organization’s personnel management process

2020 ◽  
pp. 40-46
Author(s):  
A.M. Rodomanova
Keyword(s):  
Quality Management ◽  
Management System ◽  
Human Factor ◽  
Quality Management System ◽  
Management Process ◽  
Human Resource Management System ◽  
Resource Management System ◽  
Tools And Techniques ◽  
The Relationship

Modern trends in the human resource management system in order to improve the efficiency of the company and increase the productivity of personnel contain different tools and techniques. The study of the quality management system of enterprises revealed the relationship between the concept and strategy of the company’s development and personnel policy and identified the theses that contribute to positive changes in the field of employee management. The article analyzes the internal determination of the appropriate methodology, taking into account the characteristics of employees and the human factor.

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.

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