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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.
AS9100 Revision B (2004), Quality Management Systems – Aerospace Requirements As the period for transition from the 1994 to 2000 standards passed, AS9100B was released in 2004 as an administrative revision to delete Section 2 of the Revision A standard.
The intersection of technology and quality management software prompted the emergence of a new software category: Enterprise Quality Management Software (EQMS). EQMS is a platform for cross-functional communication and collaboration that centralizes, standardizes, and streamlines quality management data from across the value chain.
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. This may have decisively contributed to the worldwide recognition of the IATF standard by many manufacturers.
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.