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View article: A Detailed Case Study on Deviation, Out-of-Specification(OOS) and CAPA Generation in Pharmaceutical Industry
A Detailed Case Study on Deviation, Out-of-Specification(OOS) and CAPA Generation in Pharmaceutical Industry Open
This review provide an overview of the various documentation of quality management system, which includes deviations, OOS and CAPA. A detailed case study of deviations, out-of-Specification and CAPA generation is beneficial for improving p…
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The support of Quality Management to sustainable development: a literature review Open
Quality Management is considered to be suitable as support for the integration of sustainability considerations in areas such as product development. The purpose of this paper is to review research in which Quality Management methods, tool…
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Essential ingredients for the implementation of Quality 4.0 Open
Purpose Quality 4.0 is concerned with managing quality in the Industry 4.0 era. Specifically, its focus is on which digital tools are used to enhance an organization’s ability to reliably give customers high-quality products. The purpose o…
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International Organization for Standardization (ISO) 15189 Open
The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management speci…
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Impact of Accreditation on Quality and Excellence of Higher Education Institutions Open
Higher education plays a crucial role in the growth and nation development in social, economic, cultural, scientific and political respects. Education empowers people to transform from a human being to having human resources. In present co…
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The ISO 9001:2015 Quality Management System Standard: Companies' Drivers, Benefits and Barriers to Its Implementation Open
Purpose: The aim of this study is to evaluate companies' perception of the latest version (2015) of ISO 9001 in terms of motivations that pushed companies to the implementation of a Quality Management System. Methodology: The research was …
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Quality 4.0: An Overview Open
Quality management practices are widely implemented by companies, as they constitute a competitive advantage. Nowadays it is almost mandatory to follow quality standards, in order to make a product available on the market. However, facing …
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Impact of quality management systems in the performance of educational centers: educational policies and management processes Open
In this paper, the findings of an I + D + i research are presented. In this study, an analysis was conducted to assess 14 educational centers where in one of two distinct quality systems had been implemented: the EFQM (European Foundation …
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The utility of measurement uncertainty in medical laboratories Open
The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level …
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The new International Standard ISO 17034: general requirements for the competence of reference material producers Open
The International Organization for Standardization (ISO) has published ISO 17034:2016 on the minimum requirements for the competence of reference material producers. Previously these requirements were addressed in ISO Guide 34:2009, origin…
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Investigating the effects of quality factors and organizational factors on university students’ satisfaction of e-learning system quality Open
E-learning systems have become widely recognized tools for university learning over the world, identifying the factors affecting students’ satisfaction has always been a major interest both in academia and in practice. Thus, this study aim…
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ISO 9001:2015 adoption: A multi-country empirical research Open
Purpose: This paper aims at identifying obstacles, benefits, leading practices and lessons learned in the transition/certification of the revised standard for quality management systems ISO 9001:2015 for organizations in various sector, co…
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Implementation of quality management for clinical bacteriology in low-resource settings Open
The implementation of QMS in clinical bacteriology in hospital settings will ultimately boost a culture of quality to all sectors of healthcare in low-resource settings.
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Construction of a quality model for machine learning systems Open
Nowadays, systems containing components based on machine learning (ML) methods are becoming more widespread. In order to ensure the intended behavior of a software system, there are standards that define necessary qualities of the system a…
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Total Quality Management and Business Excellence Open
All companies around the world aim to reach excellence in their work. Thus, successful companies keep following scientific and technological advancement to improve their business. Thus, new notions must be presented, mainly through vast co…
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Determinants of information system quality and data quality in management accounting Open
Data quality is critical to adequately perform management accounting (MA) tasks, and information systems (IS) provide the data for the MA domain. However, IS can vary vastly across firms, which may influence the basis for rational decision…
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Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory Open
SUMMARY This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standa…
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The Quality Management System as a Driver of Organizational Culture: An Empirical Study in the Portuguese Textile Industry Open
Purpose: The purpose of this paper is to analyse the Portuguese textile industry in which way quality culture influences the organization’s performance. Thus, it was created an investigation model made up of three hypotheses. The aim was t…
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Implementing quality assurance system for open and distance learning in three Asian open universities: Philippines, Indonesia and Pakistan Open
Purpose Quality assurance (QA) in open and distance learning (ODL) has always become universal concerns of stakeholders. The quality of ODL has been confronted with challenges in terms of the diversity of inputs, processes, the complex sup…
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Manajemen mutu terpadu Open
Implementation of the Total Quality Management in the Learning Quality Management System in Educational Institutions. This study aimed to analyse the implementation of the Total Quality Management (TQM) in the learning quality management s…
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Development of an Implementation Framework for Integrated Management System Based on the Philosophy of Total Quality Management Open
The focus of this paper is to develop a framework for implementation of integrate management systems (ISO 9001, ISO 14001, OHSAS 180001 and SA 8000). At present, these management systems are used individually in several industrial organiza…
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Critical Factors Affecting the Quality of Industrialized Building System Projects in China Open
Whilst the benefits of applying an industrialized building system (IBS) have been well recognized globally in the construction industry, the application of IBS is particularly limited in developing countries such as China, and quality is c…
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Does quality management system help organizations in achieving environmental innovation and sustainability goals? A structural analysis Open
The swift decline in the quantity and quality of natural resources and the public’s increased awareness about it is putting steep pressure on manufacturing and services firms to follow eco-friendly practices. The United Nations has made it…
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A Study of Quality Assessment in Higher Education within the Context of Sustainable Development: A Case Study from Czech Republic Open
Quality has become an increasingly important and critical success factor at higher education institutions, particularly universities. Numerous discussions have been held about education quality in the context of sustainable development. Ho…
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From a Quality Management System (QMS) to a Lean Quality Management System (LQMS) Open
Purpose This paper deals with the subject of “Lean Normalization.” The purpose of this paper is to propose a comprehensive methodology which combines the benefits of both International Organization for Standardization (ISO) standards and L…
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Exploring quality challenges and the validity of excellence models Open
Purpose The purpose of this paper is to identify and explore important quality-related challenges facing organizations, and investigate how current excellence models incorporate these challenges. Design/methodology/approach The paper is ba…
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Manajemen Mutu Terpadu Open
Total Quality Management is an important management process that has been used by industries in the world. The concept is used in the development and acquisition of systems such as satellite systems and aircraft to prepare officers' perfor…
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Does IS0 9001 quality management system support product innovation? An analysis from the sociotechnical systems theory Open
Purpose Building on the sociotechnical systems theory (STS), the purpose of this paper is to investigate the direct impacts of the social and technical QMs (ISO 9001) practices on both incremental and radical product innovation and the dir…
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The Level of Maturity of Quality Management Systems in Poland—Results of Empirical Research Open
This paper examines the problem of measuring the maturity of quality management systems. The main scope of the study is to measure the level of maturity of quality management systems in organizations with an implemented quality management …
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External quality assessment programs in the context of ISO 15189 accreditation Open
Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participatio…