DIN Standards Committee Medicine
DIN EN ISO 9000
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015
Qualitätsmanagementsysteme - Grundlagen und Begriffe (ISO 9000:2015); Deutsche und Englische Fassung EN ISO 9000:2015
This standard describes the fundamental concepts, principles and vocabulary of quality management and defines associated terms which are universally applicable to the following: - organizations seeking sustainable success through the implementation of quality and other management systems; - customers seeking confidence in an organization's ability to deliver satisfactory products; - organizations seeking confidence in their supply chain that their product requirements will be met; - all interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; - organizations performing conformity assessments in accordance with the requirements of ISO 9001; - all providers of quality management training; - developers of related standards. This standard is the basis of other ISO standards on quality management systems and serves as a normative reference standard for many of them. It helps the user to understand the principles, system models and concepts of quality management in order to implement a quality management system more effectively and efficiently and to benefit from other ISO standards on quality management systems. In addition to DIN EN ISO 9000 "Quality management systems - Fundamentals and vocabulary" and DIN EN ISO 9004 "Managing for the sustained success of an organization - A quality management approach", this International Standard is one of the three core ISO standards for quality management systems. Other standards that have been prepared to support the implementation of a quality management system are the ISO 10000 series. They contain guidelines for customer satisfaction, quality plans, quality management in projects, configuration management, measurement processes and measuring equipment, documentation, realizing financial and economic benefits of quality management systems, training, statistical techniques, people involvement and competence, selection of quality management system consultants and for auditing management systems. The committee responsible for this standard is NA 147-00-01 AA "Qualitätsmanagement" ("Quality Management") at DIN.