Quality Management at Greggersen
Responsibility we live by.
More than just a standard
Quality is the foundation for safety, trust and the reliability of our products & systems.
Particularly in sensitive fields such as medical technology and central gas supply systems, we bear a special responsibility, as patient safety ultimately depends on our work. That is why we have established a quality management system that goes far beyond regulatory requirements.
As a manufacturer of medical devices, we operate a quality management system in accordance with ISO 13485:2016 (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) and meet the requirements of Annex IX, Chapter I of Regulation (EU) 2017/745 (MDR). This system is continuously developed and adapted to new statutory requirements in order to guarantee maximum safety and compliance at all times.Â
In addition, we work according to a structured quality management system certified to DIN EN ISO 9001:2015. This standard provides a globally recognised framework for clear, efficient processes, continuous improvement, and a consistent focus on customer satisfaction.
Certified. Practised. Further developed.
As a manufacturer of medical devices, Greggersen Gasetechnik GmbH has a comprehensive, certified quality management system.
Our quality management system covers all company divisions from design and development through manufacturing, final inspection and sales to maintenance and repair. In this way, we ensure that quality is reliably implemented and demonstrably lived at every single step.
To consistently meet this standard, our quality management is continually reviewed, maintained and further developed. This allows us to adapt to new legal, regulatory and safety-relevant requirements at any time and sustainably optimise our processes.
For us, quality means
- clear, documented processes that create transparency
- continuous improvement of all workflows
- precise traceability and clean documentation
- regular internal and external audits
- Training & qualification of all employees
- Supplier quality that meets our high standards
- Risk management that detects and eliminates hazards early
Transparency is a matter of course for us.
All current certificates are available for download on this page.