Quality controlled from start to finish
Quality Control is the foundation of Europlaz Technologies' business. We pride ourselves on our systems and processes. The Europlaz Quality Management Team provide a comprehensive regulatory service and compliance.
Certifications
- Class 10,000 cleanrooms accredited to ISO 14644-1 Class 7
- Certified to ISO 9001-2008
- Certified to ISO 13485: 2003
- Certified to ISO 13485: 2003 CMDCAS
- Europlaz can CE Mark your products and compile your regulatory files
ISO 9001:2010
ISO 13485: 2003
CE Marking
Each of the three Cleanrooms are monitored on a quarterly basis :
Air particulate monitoring
in accordance with ISO14644-1:1999 - cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness.
Microbiological monitoring
in accordance with ISO14698-1:2003 - Cleanroom and associated controlled environments.
Biocontamination control
Part 1 : General principles and menthods.
Microbial monitoring
includes passive air sampling(using settle plates) and active air microbial monitoring (using RCS centrifugal air sampler) for bacteria and fungi.
Surface sampling for bacteria and fungi
using contact plates is also carried out at various locations and includes work stations, walls and floors.
