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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015 ). [ 1 ]
ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices in order to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and ...
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.
Quality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. [1] In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with high quality standard. [2] [3] [4]
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".
David A. Garvin lists eight dimensions of quality: [9] [10] Performance is a product's primary operating characteristics. For example, for a vehicle audio system, those characteristics include sound quality, surround sound, and Wi-Fi connectivity. Conformance refers to the degree to which a certain product meets the customer's expectations.