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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 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.
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 22004:2014 Food safety management systems – Guidance on the application of ISO 22000; ISO 22005:2007 Traceability in the feed and food chain – General principles and basic requirements for system design and implementation; ISO 22006:2009 Quality management systems - Guidelines for the application of ISO 9001:2008 to crop production)
AS 9100 Revision B (2004), Quality Management Systems – Aerospace Requirements. As the period for transition from the 1994 to 2000 standards passed, AS 9100B was released in 2004 as an administrative revision to delete Section 2 of the Revision A standard. [12]
ISO 9000:2015 Quality management systems – Fundamentals and vocabulary; ISO 9001:2015 Quality management systems – Requirements; ISO/TS 9002:2016 Quality management systems – Guidelines for the application of ISO 9001:2015; ISO 9004:2018 Managing for the sustained success of an organization – A quality management approach
ISO 10007 "Quality management — Guidelines for configuration management" is the ISO standard that gives guidance on the use of configuration management within an organization. [1] [2] "It is applicable to the support of products from concept to disposal." [3] The standard was originally published in 1995, and was updated in 2003 and 2017.