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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 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.
Chapter 10: Improvement; The process-oriented approach to business processes that is addressed in the ISO 9001:2015 is the base of the standard. It looks at the business processes in a process environment in which there are interactions and interfaces that need to be recognized, mapped and controlled by the quality management system.
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 D (2016), Quality Management System – Requirements for Aviation, Space and Defense Organizations The update of AS9100 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 ...
ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices 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 ...
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ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).