Accreditation (Accreditation Certificate)

The DIN EN ISO/IEC 17021-1:2015 describes the "General requirements for accreditation bodies accrediting conformity assessment bodies". Such an accreditation body is the German Accreditation Body (Deutsche Akkreditierungsstelle GmbH, DAkkS). It confirms the impartiality and objectivity of the conformity assessment bodies in the context of an authorization procedure.
With the admission of the conformity assessment body shall be entitled to list the accreditation logo, for example, the DAkkS logo on the issued certificates.
DQS Medizinprodukte GmbH assesses management systems and products on the basis of nationally and internationally recognized norms and standards. The for this purpose presented accreditations are:

DAkkS Deutsche Akkreditierungsstelle
DIN EN ISO 9001, DIN EN ISO 13485:2016, DIN EN ISO 15378

SCC Standards Council of Canada
ISO 13485

MDSAP Requlatory Authorities Council
(TGA Australia, ANVISA Brazil, Health Canada, MHLW/PMDA Japan, US FDA)

ZLG Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten

Richtlinie 93/42/EWG

Here you will find an overview of all our offered, accredited audits, which we can conduct in cooperation with the DQS Group.

Accreditation means that we have been accredited according to internationally recognized standards and therefore offer the highest quality and the best services. This gives you an additional guarantee that the certificates issued by us are credible and objective.
In addition, these accreditations reduce the risk for you and your customers and gives you confidence that we were evaluated based on our expertise and efficiency.