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Disciplines like systems thinking are bringing more holistic approaches to quality so that people, process and products are considered together rather than independent factors in quality management. Government agencies [ 6 ] [ 7 ] and industrial organizations [ 8 ] [ 9 ] that regulate products have recognized that quality culture may assist ...
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service.
"A term first used to describe a management approach to quality improvement. Since then, TQM has taken on many meanings. Simply put, it is a management approach to long-term success through customer satisfaction. TQM is based on all members of an organization participating in improving processes, products, services and the culture in which they ...
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
In such contexts an "end-to-end" view of quality from management to operation is vital. Quality engineering integrates methods and tools from enterprise architecture-management, Software product management, IT service management, software engineering and systems engineering, and from software quality management and information security management.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
The international standard ISO 9000:2015 (Title: Quality management systems - fundamentals and vocabulary) defines the term in chapter 3.5.3 as a "set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives".
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