About Us

• History
  • Milestones in Biohit's history
• Environment
  • Environmental milestones
• Quality
  • Production
  • Quality Control
  • Quality Management Certificates
  • Accredited Pipette Calibration
  • Liquid Handling Certificates
  • Tip Quality Certificates
  • Regulatory Affairs
• R & D
• Career
• Glossary

Quality

All of Sartorius Biohit’s products and processes from R&D to production and from marketing to sales comply with ISO 13485 quality standards, which cover the manufacture of medical device, and also with ISO 9001 and ISO 14001 quality and environmental standards. ISO 8 Clean Room certification is being sought for the pipette tip production process in Kajaani.

Biohit manufactures almost all of its products itself, using clean rooms and demanding raw materials. Pipette components and tips are designed and made by Sartorius Biohit in Finland under strict quality controls. Our pipette assembly plant in Shuzou, China, complies with the same quality standards.

• The Quality Management System of Sartorius Biohit complies with the ISO 9001 and the ISO 13485
• The Sartorius Biohit Environmental Quality Management complies with the ISO 14001 Environmental standard.
• Certified by Det Norske Veritas (DNV)
• Accredited pipette calibration laboratories in Finland (FINAS), Germany (DKD), France (COFRAC), Russia (Gosstandart) and the UK (UKAS) are accredited and ISO 17025 certified.