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DIN Standards Committee Health Technologies

Overview

This standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International 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. The introduction of a quality management system should be a strategic decision of an organization. A stable quality management system can help an organization to improve its overall performance and provide a sound basis for sustainable development initiatives. The design and implementation of an organization's quality management system are influenced by the context of the organization and the changes within that context, in particular with regard to: a) the specific aims of the organization; b) the risks associated with its context and aims; c) the needs and expectations of its customers and other relevant interested parties; d) the products and services that it provides; e) the complexity of processes and their interaction; f) the competence of persons within the organization doing work on its behalf; g) the size and structure of the organization. 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. This standard has been prepared with the help of the basic structure for management system standards ("High Level Structure") introduced by ISO. The basic structure, which is given in Annex SL, Appendix 2 of the ISO/IEC Directives - Part 1, Consolidated ISO Supplement, 2013, contains, in addition to the structure, uniform basic text, common terms and basic definitions for use in management system standards. The German translation of the basic structure has been agreed between Germany, Austria and Switzerland and applies to all translations of management system standards that fully or partially follow the ISO basic structure. The committee responsible for this standard is NA 147-00-01 AA "Qualitätsmanagement" ("Quality Management") at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 147-00-01 AA - Quality Management  

Responsible european committee

CEN/BT - BT Technical Board