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Certified Management Systems

ISO 9001 und QMS

Certificate Holder: Sysmex INOSTICS GmbH

Test Mark Number: 0000051364

The certificate holder's Management System corresponds to standards:

  • ISO 9001:2008
  • EN ISO 13485:2012
Sysmex logo 3zu2
Certificate scopes:
  • ISO 9001:
    Research, design, development and manufacturing of “lab developed tests” as well as marketing, sales and support of service provision
  • QMS:
    Design and Development, Manufacture and Distribution of molecular in-vitro diagnostic products including "Companion Diagnostics" used in the management of cancer
Description:

The Sysmex INOSTICS GmbH has a certified quality management system for the following scope:

- according to EN ISO 13485:2012 and EN ISO 13485:2012/AC:2012 

Design and Development, Manufacture and Distribution of molecular in-vitro diagnostic products including "Companion Diagnostics" used in the management of cancer

- according to ISO 9001:2008

Research, design, development and manufacturing of “lab developed tests” as well as marketing, sales and support of service provision

The management system is subject to a regular, annual monitoring by TÜV Rheinland.

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: Sysmex INOSTICS GmbH

Falkenried 88
20251 Hamburg
Deutschland