scholarly journals CERTIFICATION OF QUALITY MANAGEMENT SYSTEM OF LLC «CENTER OF PHARMACEUTICAL ANALYTICS» ACCORDING TO THE REQUIREMENTS OF ISO 9001:2015 (GOST R ISO 9001-2015) (REVIEW)

2019 ◽  
Vol 8 (1) ◽  
pp. 113-117
Author(s):  
A. A. Krylatova ◽  
I. E. Shohin ◽  
E. P. Obrazcova
Keyword(s):  
Quality Management ◽  
Management System ◽  
Production Management ◽  
System Analysis ◽  
Quality Management System ◽  
Research Work ◽  
Dissolution Kinetics ◽  
Iso 9001 ◽  
Pharmacokinetic Studies ◽  
Two Stages

Introduction. In 2018 «Center of Pharmaceutical Analytics» LLC successfully passed the certification of quality management system for compliance with the requirements of ISO 9001: 2015 and GOST R ISO 9001-2015 «Quality Management System. Requirements». Text. Certification was conducted by the Certification Association «Russian Register» – a Russian company, which is an accredited body for certification of management systems of organizations. This article describes the program of certification audit of the «Russian Register», which includes: certification, consisting of two stages, inspection checks during the first and second year and re-certification audit during the third year before the expiration of the certificate. The structure of works on confirmation of the certificate of conformity of «Russian Register» includes field audits designed to assess the degree of compliance of the organization with the established requirements of the standard for compliance with which certification was carried out [1]. The objectives of the certification audit were: verification of compliance of the management system with the requirements of ISO 9001: 2015 (GOST R ISO 9001-2015), verification of established processes and documentation of the management system of the organization; assessment of the ability of the management system to ensure compliance with applicable legislative, regulatory and contractual requirements; assessment of the effectiveness of the management system to ensure that the goals can be achieved; identification of areas for possible improvement of the management system. The audit was conducted over two days on processes and units related to the activities of the organization. The audit confirmed the scope of certification in respect of: research work, bioanalytical studies, pharmacokinetic studies, STCR (comparative text of dissolution kinetics). The scope of the audit included verification of adequacy, compliance of activities and elements of the management system, including: production, management and support processes; policies; goals; organizational structure of management; documentation of management system, analysis of measures taken by the organization to eliminate the problem areas identified at the 1st stage of certification [2]. Conclusion. In September 2018, the analytical center was issued certificates of compliance with the requirements of GOST R ISO 9001:2015 in the certification Association «Russian Register» with the accreditation of the Federal service for accreditation of the Russian Federation (Rosaccreditation); international standard ISO 9001: 2015 in the Certification system of the Russian Register, a member of the international forum on accreditation IAF; certificate of conformity.

scholarly journals The quality management system in libraries’ activities

2021 ◽  
pp. 65-72
Author(s):  
E. A. Kosolapova
Keyword(s):  
Quality Management ◽  
Management System ◽  
System Analysis ◽  
Customer Orientation ◽  
Quality Management System ◽  
Quality Standard ◽  
Iso 9001 ◽  
Quality Of Services ◽  
Library Staff

Active expansion of methods for searching, collecting, processing, storing and providing information, as well as emergence of competitors for libraries, gave rise to the problem of the quality of services provided. To raise the quality of services, it is necessary to form the institutions’ own quality management system (QMS), based on the ISO 9000 series standards.The article considers the main data of a number of libraries of the Russian Federation on the QMS implementation and development. The emphasis is made on the fact that implementation of the quality management system guarantees meeting the requirements and expectations of library users, and hence the implementation of one of the principles of the ISO 9001 standard - customer orientation. The quality management system gives confidence to the management and staff of the library, as well as to consumers in the provision and expectation of products and services that fully meet the requirements of the ISO 9001 quality standard.It is emphasized that the QMS implementation is impossible without the library staff participation. It is important to share responsibilities among the library staff, to create a working group led by a senior management representative, to study customer requirements for the library’s products and services, and prepare and document the organization’s quality management system’ procedures. Continuous perfection of the library’s quality management system contributes to the improvement of the entire organization management activities.The object of this article is to substantiate theoretically the importance of using the quality management system in modern libraries. In accordance with it, the following general scientific methods were applied: system analysis as the main method, content analysis of scientific articles and GOSTs of the 9000 series in the field of quality, terminological analysis.

Quality Management System Implementation Based on Lean Principles and ISO 9001:2015 Standard in an Advanced Simulation Centre

2021 ◽  
Vol 51 ◽  
pp. 28-37
Author(s):  
Maria Angeles Tebar Betegon ◽  
Víctor Baladrón González ◽  
Natalia Bejarano Ramírez ◽  
Alejandro Martínez Arce ◽  
Juan Rodríguez De Guzmán ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
System Implementation ◽  
Lean Principles ◽  
Simulation Centre

ISO 9001:2000 based quality management system via ABET-based accreditation

2011 ◽  
Vol 7 (2) ◽  
pp. 125 ◽  
Author(s):  
D. Thandapani ◽  
K. Gopalakrishnan ◽  
S.R. Devadasan ◽  
C.G. Sreenivasa ◽  
R. Murugesh
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001

Intensifying effects of COVID-19 on economic growth, logistics performance, environmental sustainability and quality management: evidence from Asian countries

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Muhammad Ikram ◽  
Yichen Shen ◽  
Marcos Ferasso ◽  
Idiano D’Adamo
Keyword(s):  
Economic Growth ◽  
Quality Management ◽  
Environmental Performance ◽  
Management System ◽  
Quality Management System ◽  
Iso 14001 ◽  
Iso 9001 ◽  
Asian Countries ◽  
Content Type ◽  
Goods And Services

Purpose This study aims to explore the effects of the COVID-19 outbreak on exports of goods and services, logistics performance, environmental management system (ISO 14001) certification and quality management system (ISO 9001) certification in top affected Asian countries of India, Iran, Indonesia, Philippines, Bangladesh and Pakistan. Design/methodology/approach A novel grey relational analysis models’ approach is used to examine the inter-relationship between COVID-19 economic growth and environmental performance. Moreover, the authors applied a conservative (maximin) model to investigate which countries have the least intensifying affected among all of the top affected COVID-19 Asian countries based on the SS degree of grey relation values. The data used in this study was collected from multiple databases during 2020 for analysis. Findings Results indicate that the severity of COVID-19 shows a strong negative association and influence of COVID-19 on the exportation of goods and services, logistics performance, ISO 9001 and ISO 14001 certifications in all the six highly affected countries during a pandemic outbreak. Although the adverse effects of COVID-19 in exporting countries persisted until December 31, 2020, their magnitude decreased over time in Indonesia and Pakistan. During the COVID-19 outbreak, Pakistan showed comparatively better performance among the six top highly affected Asian countries due to its smart locked down strategy and prevents its economy from severe damages. While India and Iran export drastically go down due to a rapid increase in the number of COVID-19 cases and deaths. Research limitations/implications The research findings produce much-required policy suggestions for leaders, world agencies and governments to take corrective measures on an emergent basis to prevent the economies from more damages and improve their logistics, environmental and quality performance during the pandemic of COVID-19. Originality/value This study develops a framework and investigates the intensifying effects of COVID-19 effects on economic growth, logistics performance, environmental performance and quality production processes.

scholarly journals Gestão do Judiciário e gestão da qualidade: uma questão de princípios - Judiciary management and quality management: a question of principles

2019 ◽  
Vol 1 (2) ◽  
Author(s):  
Alex Pizzio Da Silva ◽  
José Eudacy Feijó Paiva
Keyword(s):  
Quality Management ◽  
Public Administration ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
The Public ◽  
Constitutional Principle ◽  
Judicial Administration ◽  
The Subject ◽  
Point Of Reference

<p>O objetivo deste artigo é contribuir ao debate acerca da gestão do Poder Judiciário tendo como referência o princípio constitucional da eficiência na administração pública e os princípios da gestão da qualidade. Sob esse enfoque são abordados os temas da crise na administração pública e na administração judiciária. Através de uma revisão bibliográfica em livros e artigos levantou-se as contribuições de autores sobre o tema em análise. Uma correlação entre os princípios da qualidade e a realidade encontrada na administração de unidades judiciárias, através das fontes analisadas para o estudo, é realizada com o fim de demonstrar a validade da aplicação dos princípios para nortear as mudanças necessárias para a melhoria da prestação jurisdicional e a aumentar a satisfação da sociedade. O artigo apresenta a aplicabilidade de um sistema de gestão da qualidade, conforme o modelo da norma ABNT NBR ISO 9001:2015, como uma alternativa eficaz para que o Poder Judiciário apresente a resposta mais adequada para a necessidade de melhoria na eficiência da gestão do Poder Judiciário.</p><p> </p><p>The purpose of this article is to contribute to the debate about the management of the Judiciary having as point of reference the constitutional principle of efficiency in the Public Administration and the principles of quality management. This approach addresses the issues of crisis in the public administration and judicial administration. Through a bibliographical review in books and articles the contributions of authors on the subject under analysis were compiled. A correlation between the principles of quality and the reality found in the management of judicial units, through the sources analyzed for the study, is established in order to demonstrate the validity of the application of the principles to guide the changes necessary to improve the jurisdictional performance and to increase the satisfaction of society. The article presents the applicability of a quality management system, according to the model of ABNT NBR ISO 9001: 2015, as an effective alternative for the Judiciary to provide the most appropriate response to the need of improving the efficiency of the Judiciary management.</p><p> </p>

scholarly journals PENERAPAN SISTEM MANAJEMEN MUTU BERDASARKAN STANDAR ISO 9001 : 2005

2018 ◽  
Vol 13 (1) ◽  
pp. 1-9
Author(s):  
Shakina Nur Fitriyna ◽  
Lenggogeni Lenggogeni ◽  
R. Eka Murtinugraha
Keyword(s):  
Quality Management ◽  
Human Resources ◽  
Construction Management ◽  
Management System ◽  
Quality Management System ◽  
Development Project ◽  
Iso 9001 ◽  
Management Consultant ◽  
Questionnaire Form ◽  
Made In

This study aims to find out how the implementation of quality management system based on clause in ISO 9001: 2015 on podomoro golf project development project cimanggis with PT. Wijaya Karya Building Building as a contractor. This study is descriptive using clauses in ISO 9001: 2015 as a way of knowing the implementation of quality management system from owner, construction management consultant, and contractor, with questionnaire form about application of field. Questions are made in clauses 4 to clause 10 in ISO 9001: 2015.The results in this study indicate that the implementation of quality management system based on clause in ISO 9001: 2015 from the owner is "Rarely" applied with the percentage of assessment between 50% to 74.99%. The construction management consultant is "Always" applied to the assessment percentage of 75% to 100%. From the contractor's side is "Always" applied with the percentage of valuation between 75% to 100%. From these results obtained factors - factors that become constraints on the implementation of quality management system based on clauses in ISO 9001: 2015, the method or procedure, human resources (HR), and implementation or operational work.

scholarly journals Employees’ process and risk-oriented thinking

2020 ◽  
Vol 13 (2) ◽  
pp. 206-217
Author(s):  
V. P. Soloviev ◽  
T. A. Pereskokova
Keyword(s):  
Quality Management ◽  
Management System ◽  
System Analysis ◽  
Quality Management System ◽  
Iso 9000 ◽  
International Organization ◽  
Analysis Method ◽  
Preventive Action ◽  
National Organizations ◽  
Potential Risks

The authors of the article explore the problem of introducing process and risk-oriented thinking in national organizations. In 2000 the International Organization for Standartization, ISO, announced process approach as the basis principle of management in any organization. It became the embodiment of Deming’s postulate who recommended to consider any activity as a technological process. The authors show the practicability of transition from the functional structure of an organization to integrated process. New ISO 9000:2015 standards reflect presentday challenges and require that organizations should carry out risk assessment and accounting. One of the key objectives of the quality management system is to act as the prevention tool. Preventive action lies in using riskoriented thinking in formulating requirements to the quality management system. The authors introduce the system analysis method in risk management to reveal potential risks and plan preventive action.

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