Quality and Certification

Focus on Quality

Since its foundation dianova has attached great importance to quality. This applies to the products, to internal structures and processes as well as to employees and services. At dianova quality is a management issue and constitutes an integral part of all our work flows and is continuously improved.

Increasing customer satisfaction is the main motivation for the continuous optimization of the processes, the competence of the staff, the enhancement of the services, the quality of dianovas partner companies and the high standard of the products.

Quality for you

Our customers are our main motivation with regard to these efforts in all work areas.  The continuous optimization of our processes, the competence of our staff, the enhancement of our services, the quality of our partner companies and the high standard of our products are aimed at contributing to a good cooperation with you. We believe that this is the best way to improve customer satisfaction.

Product Quality

All products in our range are procured from manufacturers or production labs regularly inspected by dianova. These inspections ensure that our partners maintain adequate structures and procedures for good manufacturing practice. Accordingly, many partners hold ISO certificates. Another quality assurance measure is the random sampling of reagents in independent test labs. Moreover, dianova’s internal control system ensures that cumulative deficiencies are recognized immediately, customers affected are notified and remedy measures are implemented in production.

Adequate production and quality assurance processes at the manufacturer’s premises guarantee that the reagents function in the immune detection methods and species specified in the data sheet. Insofar as a dianova product has been correctly selected and applied by the user to the detection system and sample material, the results will be correct.

In the event that dianova’s antibodies and reagents do not meet the properties specified in the data sheet in whole or in part, we will initiate suitable measures. This procedure shall be precluded if a product has been used in an application which has not been confirmed yet as specified in the data sheet or a product has been selected or treated incorrectly.

In such a case we require comprehensive information to find the optimum solution For efficient support please keep the following details ready: catalog number, date of purchase, batch number, product  storage (temperature, with/without additives, aliquoting), blockage, antibody, detection system, solutions, thinners, incubation times and temperatures as well as details with regard to positive or negative controls. This will enable our experts to provide you with suitable recommendations or offer the best replacement.

dianova – a certified company

At dianova quality is of paramount importance and subject to  strict control. Internal controls and audits are carried out in addition to on-site inspections by independent, external inspection companies. In 2003 the TÜV Rheinland/Berlin/Brandenburg successfully completed the first comprehensive certification process. Since then our company has been certified pursuant to the international DIN EN ISO 9001:2015 standard.

Certificate DIN EN ISO 9001:2015

dianova’s work and production processes are based on a certified quality management system pursuant to DIN EN ISO 9001:2015. This includes cooperation with recognized production labs, continuous optimization of our processes, enhancement of our services and training of our staff with focus on a profound understanding of our products. In this way we ensure that we are providing labs, users and customers with safe, efficient and high quality products for diagnostics as well as a high degree of health protection for patients.

To this end, dianova consistently implements all the requirements stipulated in the European Directive on in-vitro diagnostic medical devices within the company.

Certificate valid until 25.08.2021 (pdf)