scholarly journals PETRONAS Gas Bhd Experiences in Accreditation of ISO 9002 Quality Assurance Standard for its Pipeline Operations Division in Malaysia

1996 ◽  
Author(s):  
Muhamed Ali Hashim Mohamed
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Iso 9000 ◽  
Quality System ◽  
Implementation Plan ◽  
Trial Implementation

Some companies seek ISO 9000 registration for competitive reasons or because customers require it. PETRONAS Gas Bhd, pipeline division company TOD or Transmission Operations Division, seek ISO 9000 registrations purely for the benefits since the management believes that a well designed and well implemented quality system has a process which tends to be lean, sensitive to customers needs, highly reactive and efficient. This paper informs how TOD sets out to put ISO 9002 international quality system to work in its operations. A Quality Steering Council was formed in Feb. 1994 and the HSE and Quality Management Manager was appointed as management representative. The current working system was first assessed. Next, an implementation plan was prepared. Training was provided and the quality manual prepared followed by all the necessary work procedures and instructions. Finally there was trial implementation and actual “live” implementation. In January 1995 TOD ISO 9002 registration was approved.

Engineering Software Quality Management and ISO 9000

1993 ◽  
Author(s):  
Stephen J. Schoonmaker
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Software Quality ◽  
Iso 9000 ◽  
International Organization ◽  
Management Model ◽  
Global Marketplace ◽  
Engineering Software ◽  
Software Quality Management ◽  
Independent Auditing

Abstract This paper presents a management model for “in-house” engineering software. This model expands on a previous publication by the author, and this model is intended to satisfy the requirements of an ISO 9000 registration. ISO 9000 is the quality assurance standard of the International Organization for Standardization. ISO 9000 registration, which includes on-site independent auditing, is becoming a requirement for some businesses operating in the global marketplace. This paper draws on the author’s first-hand experience with this process. The author also urges the ASME to produce guidelines or standards on this material which will allow other mechanical engineers to benefit from his experience.

scholarly journals Process validation: An essential process in pharmaceutical industry

2015 ◽  
Vol 1 (4) ◽  
pp. 179
Author(s):  
Brahmaiah Bonthagarala ◽  
Sandhya Ch. ◽  
Pusuluri Dharani Lakshmi Sai ◽  
Konkipudi Venkata Sivaiah
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Pharmaceutical Industry ◽  
Manufacturing Process ◽  
Iso 9000 ◽  
Pharmaceutical Manufacturing ◽  
Process Validation ◽  
The Us ◽  
Tablet Manufacturing

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

REGULARITIES OF THE PREPARATION OF RUSSIAN ENTERPRISES FOR CERTIFICATION OF COMPLIANCE WITH ISO 9000 SERIES

2019 ◽  
Vol 6 (3) ◽  
pp. 54-60
Author(s):  
Mikhail Jurievich Rudiuk ◽  
Anastasiia Vladislavovna Gerasimova ◽  
Ekaterina Mikhailovna Pomozova
Keyword(s):  
Quality Management ◽  
Iso 9000 ◽  
World Market ◽  
Practical Significance ◽  
Management Systems ◽  
Quality Management Systems ◽  
Strict Adherence ◽  
The World ◽  
Legislative Framework ◽  
Current Stage

The authors' task was to analyze the development of quality management systems at the current stage in Russia, as well as at the previous stage in the USSR. As a result, we came to the conclusion that the factors stimulating the implementation of ISO 9000 standards are the need to promote products on the world market, as well as the possibility of receiving orders from the state. In the future, strict adherence to these standards will allow enterprises to significantly reduce the likelihood of lawsuits from consumers, which is important in the context of the development of the legislative framework and increased control over the business. The practical significance of the article is the possibility of familiarizing management and personnel with quality services, whose task is to prepare for certification for compliance with ISO 9000 standards in how this process took place in other companies. The originality of this work is to summarize the experience of implementation of ISO 9000 standards at enterprises and to analyze the factors contributing to or hindering this process.

Quality assurance and quality improvement in medical practice – Part 1. Definition and importance of quality in medical practice

2012 ◽  
Vol 153 (3) ◽  
pp. 83-92
Author(s):  
Sándor Gődény
Keyword(s):  
Quality Assurance ◽  
Health Status ◽  
Quality Management ◽  
Medical Practice ◽  
Quality Measurement ◽  
The European Union ◽  
Management Quality ◽  
Hungarian Population ◽  
Healthcare Finance

In Hungary healthcare finance has decreased in proportion with the GDP, while the health status of the population is still ranks among the worst in the European Union. Since healthcare finance is not expected to increase, the number of practicing doctors per capita is continuously decreasing. In the coming years it is an important question that in this situation what methods can be used to prevent further deterioration of the health status of the Hungarian population, and within this is the role of the quality approach, and different methods of quality management. In the present and the forthcoming two articles those standpoints will be summarized which support the need for the integration of quality assurance in the everyday medical practice. In the first part the importance of quality thinking, quality management, quality assurance, necessity of quality measurement and improvement, furthermore, advantages of the quality systems will be discussed. Orv. Hetil., 2012, 153, 83–92.

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.

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