Certification Procedure

Version in Deutsch   


The granting of certificates is bound to a specific procedure that is illustrated in the figure below. The certification procedure starts with a vendor requesting the certification of a specific product from the Auditing Body (OFFIS) and finishes with the granting of the certificate if the vendor passes the certification tests.

Illustration of Certification Procedure Illustration of the certification procedure
Click to enlarge
The certification process is divided into three phases that are shortly described in the following sections.

Phase I: Information

The Information Phase is intended to provide the vendor with information about the test procedure and to provide the Auditing Body with initial information about the system to be tested. If a vendor intends to have a system certified, a contract is signed between both parties. Afterwards the Short Test Phase is started.

Phase II: Short Test

In this phase, the system under test undergoes a pre-test. The results provide the vendor with an overview of how close the media created by the product under test are to the DRG Requirements Specification. Based on these results, the vendor can improve the system for the next phase, the Certification Phase.

Phase III: Certification

In this phase, the actual, intensive test of the system under test takes place. The Auditing Body requests the vendor to provide a specific number and kind of test media, which are then intensively tested by the Auditing Body. If the media are not sufficiently conformant to the DRG Requirements Specification, then the vendor may fix the system and provide modified CDs for a repeated intensive test.

Interoperability Test

If the vendor successfully passes the intensive test of the Certification Phase, the media are sent to multiple medical user partners for interoperability testing. The result of this practical test does not affect awarding of the certificate and only serves informational purposes. After the interoperability test, the certificate is issued to the vendor and the certificate is published on the project's Internet page.
A full overview of the certification procedure can be found in the following document (German language only):
PDF-Logo Prüfungsablauf zum Testat von Datenträgern mit Patienteninformationen
Ausgabe/Edition 2006 (in German language)
If you are interested in certifying your products, please send an e-mail to the address found on the contact page.
Last page update: 2013-06-10
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