Quality management system
Quality management systems ensure that the system quality, process quality and product quality are checked and improved in an organization. The aim of a quality management system is a permanent improvement in company performance.
The system is basically applicable to all industries, company sizes and structures. The system describes the methodology and provides the tools according to which the employees in quality management of a special company then align their individual procedures to ensure and improve quality.
The most widespread standard that defines the requirements for a quality management system is DIN EN ISO 9001: 2015-11 . There are also a number of industry-specific standards, such as the following:
- VDA 6.1 (automotive industry)
- IATF 16949 (automotive industry)
- EN 9100 (aviation)
- ISO 13485 (medical technology)
- TL 9000 (telecommunications)
- EFQM model of the European Foundation for Quality Management (The Excellence Model)
- Six Sigma
- LQW - quality testing
In many industries, companies are required to introduce a quality management system in order to document a company's ability to meet customer and legal requirements with the aim of customer satisfaction:
Pharmacy: A quality management system according to the guidelines of good manufacturing practice (GMP) is mandatory for the pharmaceutical industry .
|EU guidelines||Application for|
|93/42 / EEC||binding requirements of a QMS for the manufacture of medical devices|
|90/385 / EEC||for active implantable medical devices|
|98/79 / EC||for in vitro diagnostics (IVD)|
Products with CE mark:
For products in Europe with the CE mark , EU directives with legal significance apply , which prescribe a binding quality management system. The ISO 9000 series of standards and EU directives in connection with the CE mark distinguish between:
- Quality management system : extends to at least all parts of the manufacturing process
- Complete quality management system : integrates all parts of production, sales and development of the products in the QMS
- Tilo Pfeifer, Robert Schmitt (editor): Quality Management Systems , Part II in: Masing Handbook Quality Management , Carl Hanser Fachbuchverlag Munich Vienna, 6th revised edition (2014), ISBN 978-3-446-43431-8
- Angelika Kraft, Heike Goebel, Stefan Jahnes: Introduction of a quality management system at Emschergenossenschaft / Lippeverband. In: KA. Correspondence sewage, waste. 52, 11, 2005, , pp. 1258-1264.
- ECQMed / The site for hospital management, medical controlling and quality management, here: overview of magazines and literature with QM topics