ZDH-ZERT GmbH

Detail informationen

Certification Body for Management Systems

ZDH-ZERT GmbH

Wurzerstraße 4a, 53175 Bonn, Germany
D-ZM-16013-04-00 | Issue date: 22.02.2024

Kurzschreibung des Geltungsbereichs

1. Die Zertifizierungsstelle nach DIN EN ISO/IEC 17021-1 erfüllt die zusätzlichen Anforderungen gemäß IAF MD 9:2022 für Zertifizierungsstellen die im Bereich Qualitätsmanagementsysteme für Medizinprodukte gemäß ISO 13485:2016 tätig sind. Diese Kompetenz wurde festgestellt für folgende Konformitätsbewertungstätigkeiten: a) Zertifizierung von Managementsystemen nach ISO 13485:2016 Medizinprodukte – Qualitätsmanagementsysteme – Anforderungen für regulatorische Zwecke

Short description of the scope (machine translation)

1. the Certification body according to DIN EN ISO/IEC 17021-1 complied the zusätzlichen requirements according to IAF MD 9:2022 for Zertifizierungsstellen the at area quality management systems for medical products according to ISO 13485:2016 tätig are. this Competence wurde festgestellt for following Konformitätsbewertungstätigkeiten: old) certification of management systems according to ISO 13485:2016 medical products – quality management systems – requirements for regulatory application
External content of Google Maps is integrated here. Click on the button to display the map. The content can also be hidden again if required.

I consent to external content being displayed to me. This allows personal data to be transmitted to third party platforms. You can find out more about this in our data protection declaration.

Further accreditations

D-ZE-16013-01-00 | Issue date: 04.04.2023
D-ZE-16013-02-00 | Issue date: 25.11.2019
D-ZM-16013-01-00 | Issue date: 17.10.2022
D-ZM-16013-01-01 | Issue date: 22.05.2024
D-ZM-16013-01-02 | Issue date: 17.10.2022
D-ZM-16013-06-00 | Issue date: 13.11.2023
D-ZP-16013-01-00 | Issue date: 24.04.2023
D-ZP-16013-01-01 | Issue date: 29.09.2023
D-ZP-16013-01-02 | Issue date: 24.04.2023

Note on the certificate status

In addition to the currently valid accreditations, the database of accredited bodies also contains information on withdrawn and suspended accreditation certificates. The status of an accreditation is displayed in the search results. The filter “certificate status” enables a limitation of the search results.

  • Active: These accreditations are valid without restrictions.
  • Suspended: These accreditations are temporarily restricted, either in full (“fully suspended”) or for part of the scope of the accreditation (“partially suspended”).
  • Withdrawn: These accreditations have been withdrawn for the entire scope in the past six months.

Suspension or withdrawal of accreditation occurs, among other things, when an accredited conformity assessment body no longer fulfils the relevant conditions for accreditation, does not comply with the requirements placed on it, does not follow the accreditation rules or has voluntarily requested suspension or withdrawal.

The requirement to make the status of an accreditation publicly available results from the standard ISO/IEC 17011, which DAkkS is obliged to comply with.

Nach oben