Preanalytics
Quality Assurance Preanalytics Division
The quality of our products is our utmost priority. We are convinced, that quality is not achieved until the customer's request has become reality, with the production flow subject to constant control. Greiner Bio-One has therefore implemented a sophisticated and multi-level quality management system.
Our highly qualified and motivated employees implement the quality standards in all individual areas. Our cutting-edge production technology and first class control systems ensure that our products are manufactured under the highest possible safety standards.
Greiner Bio-One / Preanalytics Complies With a Number of International Standards and Guidelines
1) Quality Management System – EN ISO 9001:2000 and EN ISO 13485:2003
EN ISO 9001:2000 "Quality Management Systems - Requirements"
EN ISO 13485:2003 "Medical Devices - Quality Management Systems - Requirements"
2) Good Manufacturing Practice – Guidelines and Regulations
Good Manufacturing Practice (GMP) is of particular importance in our company and a basic prerequisite for the success of our products.
21 CFR Section 820 "Medical devices; Current Good Manufacturing Practice (GMP); Final Decree; Quality System Regulation"
3) International Working Committee
We are pioneers with regard to product standards. Greiner Bio-One co-operates in standardisation committees and determines the product standards of the future. For example, involvement in the changes to: ISO 6710 "Single-use containers for venous blood specimen collection" and the drafting of the replacement standard EN 14820 "Single-use containers for human venous blood".
4) Compulsory Product Standards
We fulfil all relevant harmonised standards relating to the two applicable directives IVDD 98/79/EC and MDD 93/42/EC, for example:
EN 550 "Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation"
EN 552 "Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation"
EN 980 "Graphical symbols for use in the labelling of medical devices"
EN ISO 14971 "Medical devices - Application of risk management to medical devices"
In addition, we also conform to:
ANSI/AAMI/ISO 11137 "Sterilisation of health-care devices - Requirements for validation and routine control - Radiation sterilisation"