Quality and certification

High level of quality, safety and service identify for a long time Bioster activity. Bioster is certified since 1996 according to all the International Standards by the accredited German notified Body TÜV Product Service for the complete range of services,

    • Sterilization by ethylene oxide, irradiation and steam;
    • Validation of processes, plants and environments;
    • Microbiological, biological and chemical analysis;
    • Design, building, certification and managing for complete
      hospital sterilization centres;
    • Design, building, certification for complete turn key sterilization systems

BIOSTER, through a detailed and precise program of quality assurance is offering to the customers easy solutions in the complete special process of sterilization delivering to the producers a certified and global service to answer many needs.

Quality in the services, measurement of the customer satisfaction, defining of new improvement targets, closer to the wishes and expectations of the market are the basis and key points of the company policy.

The Quality system is designed to develop and increase continuously levels of service with high standards the patients sterile, safe and controlled products.
All the employees are involved, during their daily activity, in applying and reaching the targets of quality periodically defined by the company management.

Bioster is certified and applies a quality system in compliance with the International standards:

    • UNI EN ISO 9001:2000
    • EN ISO 13485:2003
    • ISO EN ISO 14001:2004
    • ISO 17665:2007
    • ISO 11135:2007
    • ISO 11137:2008

The company Quality and Environment systems are precisely defined in their structure, managing and practical procedures inside the "Integrated Quality and Environment Manual".

Bioster is very proud to offer and demonstrate to the customers the reached excellence level of the company quality also through the certifications for the complete range of services released by:

American market - FDA
Japanese market - PAL, MHLW