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Quality management systems
Published in Stephen Battersby, Clay's Handbook of Environmental Health, 2023
The ISO 9000 series of quality management systems (QMS) is a set of standards that helps organisations ensure they meet customer, client and other stakeholder needs within statutory and regulatory requirements related to a product or service. The standards provide guidance and tools for companies and organisations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. The ISO 9000 family addresses various aspects of quality management and contains some of the best-known standards of the International Organisation for Standardisation (ISO). ISO is an independent, non-governmental international (global) organisation with a membership of 164 national standards bodies including the British Standards Institution (BSI) and has its secretariat in Geneva, Switzerland. Its members (or member bodies) have a say in the development of ISO standards and strategy by participating and voting in ISO technical and policy meetings.
Quality Management Systems and Risk Management
Published in Graham P. Bunn, Good Manufacturing Practices for Pharmaceuticals, 2019
A QMS is typically defined as a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing the work performed by an organization and for carrying out required Quality Assurance (QA) and Quality Control (QC) activities (1). Elements of a QMS typically include: Quality policyQuality objectivesQuality manualOrganizational structures and responsibilitiesData managementProcessesProduct qualityContinuous improvement
Quality management system
Published in Itay Abuhav, ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry, 2018
A QMS basically acts as a preventive tool that initiates activities for identifying situations where intended outcomes, for example, objectives, would not be met or identifying opportunities that help an organization in achieving its objectives. A risk-based approach is an effective concept for achieving an effective quality management system and enables the organization to determine the factors that may cause processes, activities, or operation to deviate from the planned results. The approach promotes the adaptation of preventive controls to minimize negative effects. The probability of achieving quality objectives improves because obstacles, interferences, and interruptions are identified and removed in advance. In addition, the ISO 13485 Standard demands the risk-based approach as a strategic instrument for the planning of a QMS and adopts a proactive approach toward errors and nonconformities of processes, resources and other elements of the QMS by anticipating and identifying the root causes that may emerge during realization and initiating actions, which helps address the errors in advance.
Data analytics in quality 4.0: literature review and future research directions
Published in International Journal of Computer Integrated Manufacturing, 2023
Alexandros Bousdekis, Katerina Lepenioti, Dimitris Apostolou, Gregoris Mentzas
ISO 9000:2015, Quality management systems, fundamentals and vocabulary standard (ISO 2000) defines quality management as management with regard to quality; quality assurance as part of quality management focused on providing confidence that quality requirements will be fulfilled and quality control as part of quality management focused on fulfilling quality requirements. A Quality Management System (QMS) is a part of a management system regarding quality, and it comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results. What we recognize as today’s quality profession began during the middle of the second industrial revolution (Radziwill 2018). As quality gained more and more importance over time, many quality concepts and methods have emerged. Quality models, approaches, and practices have evolved from inspection to quality control, quality assurance, quality management, and business excellence. Several models, frameworks, and tools have been developed to support organizations in managing and improving quality in all activity sectors. These include the Quality Tools and methods (such as 100% inspection and Statistical Quality Control), the ISO 9001 Quality Management International Standards, continual improvement methodologies such as Lean, Six Sigma, or Lean Six Sigma, the teaching of quality gurus such as Juran, Crosby, Deming, or Taguchi, and the business excellence models, namely, the EFQM (Europe), the MBNA (EUA), or the Deming (Japan) models or awards (Fonseca and Domingues 2018; Köksal, Batmaz, and Testik 2011).
Improvement projects with an environmental focus: A novel approach for prioritization
Published in Quality Engineering, 2023
Ambika M. Raja, Ramasamy Raju, Rajkanth Raju, Sanjeev S. Raja
Organizations worldwide are always on their toes to keep their stakeholders satisfied while remaining competitive. Organizations need an environmentally friendly approach for the attainment of sustainability in the prevailing business circumstances. Quality is widely acknowledged as a powerful instrument for achieving success. Organizations implement quality management systems (QMSs) and make efforts to get a certification. Six Sigma is a well-known QMS that improves bottom-line profitability by reducing variation and removing defects (Montgomery and Woodall 2008). It is a project-driven QMS that reduces the consumption of raw materials and energy apart from reducing scrap. Six Sigma helps save valuable resources and reduce an organization’s environmental impact (Ben Ruben, Vinodh, and Asokan 2017; Chugani et al. 2017). Thus, it can be applied with a proper environmental focus. A significant portion of the research on the sustainability of the QMS deals with the environmental dimension (Cherrafi et al. 2016). Prashar (2020) has presented a framework for the improvement of environmental performance alongside operational performance in a process industry. Lucato, Vieira Júnior, and Santos (2015) incorporated environmental variables for ensuring an increase in eco-efficiency levels.
Factors influencing the choice of a quality certification in the Spanish hospitality industry
Published in Quality Management Journal, 2021
Sidonie Djofack, Marco Antonio Camacho Robledo
The term "management system" refers to a “device that allows organizations to manage their activities, and even better their processes, so that their products or services meet the objectives they have set for themselves” (Rolland 2009). A management system can be standardized. A QMS defines the overall organizational structure, responsibilities of each stakeholder, procedures, processes, and resources to implement a successful policy. Its purpose is to guarantee the quality assurance of the product or service and to increase customer satisfaction. The standard provides a valuable model to set up and run the system. It includes features that have been the subject of a consensus among international experts. The QMS can also be certified; to send a signal to customers, that the organization is accredited, and therefore complies with certain standards. QMS Certification is generally not a legal requirement. However, a large number of companies recognize their value (Martínez-Costa and Martínez-Lorente 2007).