Berthold Detection Systems obtained the certification according to quality standard ISO 13485:2003 + AC:2007. In addition, the certification according to ISO 9001 was renewed. This achievement underlines the strong commitment to quality, by all company activities, in serving our customers in diagnostic and life science markets.

In an in-depth test process Berthold Detection Systems could fulfill every aspect of the ISO standards. The certifications confirm to the enterprise that it disposes of a quality assurance system by means of which all customer demands can be fulfilled at a constant high level. At the same time a maximum of quality and the compliance with all official directives is guaranteed.

Monitoring
All critical working processes are continuously monitored to secure documented evidence that the specified quality is achieved. In these areas, the data are analyzed and improvement activities are decided using the Corrective and Preventive Action System (CAPA).

Audits
Quality audits are carried out to verify that all activities comply with existing quality documentation and that the quality system is efficient and user-friendly. Four types of audits are defined:
Internal quality audits of all departments based on a yearly audit plan.
Audits from customers.
Audits of suppliers.
Audits from independent certifying bodies.