ISO Certificates
Since 1996, DiaSys GmbH has been certified according international quality management standards. The certification and annual monitoring audits are performed by the TÜV-Rheinland (http://www.tuv.com/en/corporate/home.jsp).
Certificates are available in German and English.
MDSAP Certificate
In Febuary 2025, TÜV Rheinland of North America, Inc., an MDSAP recognized Auditing Organization, certifies that the quality management system of the Manufacturer has been audited against and found to conform the Certification criteria for the Scope contained in this certificate. The quality management system is subject to annual surveillance audit(s).
ISO 13485:2016 - Quality Management System Certificate
In February 2025, the Certification Body of TÜV Rheinland LGA Products GmbH certifies that the organization has established and applies a quality management system for medical devices. Proof has been furnished that the requirements specified in the abovementioned standard are fulfilled. The quality management system is subject to yearly surveillance.
MDSAP Certificate
In September 2022, TÜV Rheinland of North America, Inc., an MDSAP recognized Auditing Organization, certified that our quality management system has been audited against and found to conform the Certification criteria for the Scope contained in this certificate. The quality management system is subject to annual surveillance audit(s).
MDSAP certification
AEO F Certificate
In November 2011, we have been certified as Authorized Economic Operator
with AEO F certification.
Approval of Known Consignors
In April 2012, DiaSys was granted the Approval of Known Consignors for the manufacturing facility in Alte Strasse 9, 65558 Holzheim, in accordance with EC regulation no. 300/2008. Relevant approval no. is DE/KC/00151-01.
Certificate Resources
It is part of our quality policy to commit ourselves to environmental and climate protection and to recycle our packing materials. In view of the finiteness of natural resources, the well respected Fraunhofer Institut UMSICHT is making studies on the amount by which we contribute via the company Interzero.
The attached certificate shows our individual contribution to the protection of resources as well as to the savings of blowing gas emission. We are looking forward to contributing furthermore to this positive development.
Certification of energy management system
Enoplan GmbH certifies that DiaSys Diagnostic Systems GmbH the successful implementation of a energy management system according to DIN EN ISO 50005:2021.
An internal audit has provided verification that the requirements of of DIN EN ISO 50005:2021 in implementation level 3 are are fulfilled.