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Initial Cleanrooms: Unsere Reinraumservices

Quality management & certifications

Complete process documentation and evidence of compliance with high quality standards is extremely important, particularly in cleanroom environments. The procedures we use comply with the highest international standards.  

Exakte Qualitätskontrolle in der Bearbeitung der Reinraumbekleidung

Our Europe-wide certification includes:

  • ISO 9001
  • ISO 14644-1
  • ISO 14001
  • OHSAS 18001


With our standardised quality process, compliant with GMP standards, and our in-house "Quality Master Plan" we ensure compliance with standards common to all our plants.

Quality Master Plan

Our Quality Master Plan brings together all quality assurance measures for all regions, sets the focus, and highlights how improvements can be achieved. This includes, for example, the Gold Standard for processes and service, which specifies the quality guidelines as well as operating and testing instructions for all European plants.  

In this way we can ensure that you are supplied at all times without interruption. If one plant is unable to deliver, another location simply takes on the responsibility. With this smart fail-safety system we are able to guarantee the highest level of service and supply security. You can rely on us!

Ongoing internal and external testing

Internal and external testers, laboratories, and quality controllers test our procedures and machines at regular intervals. They test laundry and sterilisation procedures with the appropriate equipment, conduct cleanroom filter and integrity tests and measure particle concentration as well as airflow speed and pressure. The monitoring programme also covers the regular calibration of all testing devices we use.

We carry out ongoing internal tests alongside the external validation and calibration plan. These are used for the continued monitoring of the ambient conditions and water systems. Examination of airborne germs and germs on surfaces, germs held in process water and staff hygiene are conducted weekly.

Certification

A large number of certificates are evidence of our high quality standards.

Zertifikat Dekra ISO 9001:2008   DEKRA
ISO 9001:2008
 
  Zertifikat Dekra 14001:2004   DEKRA
ISO 14001:2004
  Zertifikat GMP   Annual Cleanroom Requalification Audit
(EU GMP)
                     
Zertifikat BV 9001:2008   Bureau Veritas
ISO 9001:2008
  Zertifikat BV 14001:2004   Bureau Veritas
ISO 14001:2004
  Zertifikat BV OHSAS 18001:2007   Bureau Veritas
OHSAS 18001:2007
                     
Zertifikat AFAQ ISO 9001:2008   AFAQ
ISO 9001:2008