Quality management system
A quality management system ( QMS Abbr ) is a method of corporate management. The objective is systematic quality management.
Target
Quality management systems ensure that the system quality, process quality and product quality is tested and improved in an organization. Goal of a quality management system is a lasting improvement in business performance.
The system is generally applicable to all industries, company sizes and structures. The system describes the methodology and provides the Hand tool, after then align the employees in quality management of a particular company's their individual procedures to safeguard and improve the quality.
QM systems
Today, there are next to EN ISO 9001:2008 a number of sector-specific standards, as an example may be mentioned here:
- VDA 6.1 (automotive )
- ISO / TS 16949 ( automotive industry)
- The AS 9100 (aerospace )
- EN ISO 13485 (medical ) and
- The TL 9000 ( telecommunications).
QM models
- EFQM Model of the European Foundation for Quality Management ( The Excellence Model)
- Six Sigma
- LQW - quality testing
Regulations
In many industries, the company is required to implement a quality management system to document the ability of a company to meet customer and regulatory requirements with the objective of customer satisfaction:
Pharmacy: For the pharmaceutical industry, a quality management system according to the requirements of Good Manufacturing Practice (GMP ) is compulsory.
Medicine:
Additional can be certified according to EN ISO 13485 Medical Device Standard.
Products with the CE mark:
For products in Europe with CE Marking to EU Directives apply laws with significance which require a quality management system binding. The ISO 9000 series of standards and EU directives differ in conjunction with CE-mark:
- Quality management system: cover at least all parts of the production
- Full Quality Assurance System: binds all parts of the production, sales and development of products in the QMS a