Quality management system

from Wikipedia, the free encyclopedia

A quality management system (abbr. QMS ) is a method of corporate management . The aim is systematic quality management .


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.

QM systems

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:

QM models


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)

Additional, after medical standard 13485 EN ISO certified are.

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, ISSN  1616-430X , pp. 1258-1264.

Web links

  • ECQMed / The site for hospital management, medical controlling and quality management, here: overview of magazines and literature with QM topics