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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]
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.
ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published a number of separate standards which specify Quality Management System requirements for ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
This is not an isolated process, but a combination of all interacting business processes which affect the quality performance of a firm. A key requirement of IATF 16949:2016 is the fulfillment of customer-specific requirements, set up by the automotive manufacturer in addition to the quality management system of their suppliers.
AS 9100 Revision D (2016), Quality Management System – Requirements for Aviation, Space and Defense Organizations The update of AS 9100 from revision C to D includes the full text of ISO 9001:2015. In addition to aligning the structure of the aviation, space and defense requirements to the new structure of ISO 9001:2015, the following key ...
System zur Zukunftssicherung: Total Quality Management (TQM), Düsseldorf, Germany: Verein Deutscher Ingenieure, 1996, OCLC 632959402, VDI 5500; Total Quality and Marketing/Management Tools, Paris, France: AFNOR, 1998, FD X50-680; Total Quality Management: Guide to Management Principles, Turkish Standards Institution (TSE), 2006, TS 13133
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. [1] These objectives cover many aspects of the organization's operations (including product quality, worker management, safe operation, client relationships, regulatory ...