Quality at Greiner Bio-One
Quality Standard in Compliance with DIN EN ISO 9001 and DIN EN ISO 13485
Greiner Bio-One has been certified according to DIN EN ISO 9001 since 1994, and has been re-certified in 1997, 2000, 2003 and 2006 according to the new DIN EN ISO 9001:2000 through the continuing high standard of our production processes, quality controls and organisation. Since 2004 we have also been certified according to DIN EN ISO 13485:2003 to fulfil the high international requirements for manufacturers of medical devices. A total quality approach encompassing the latest production technologies, strict control of conditions and materials, as well as the qualification and development of personnel ensure constant improvement in both our products and processes. Our customers' trust in us for over 30 years certifies our high quality and our dediction to further quality improvement.
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Download Cerificate DIN EN ISO 9001
Download Certificate DIN EN ISO 13485
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CE Marking, ComplianceSince December 2003 it has been mandatory for products which fall within the scope of the European Directives 93/42/EWG for medical devices and 98/79/EG for In-vitro-Diagnostics to be correctly labelled by bearing a CE mark. In line with the definitions in these directives some of our products have been considered as medical or In-vitro-Diagnostic devices and as such have been labelled in accordance with the regulation. In our catalogue these products are labelled with a CE mark.
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Quality Assurance and Quality Control
Quality is the most important criterion in the manufacturing of our products. For this purpose, we have a control system which monitors the physical, chemical and biological quality of our products. The checking of quality starts with the incoming raw material, is continued in production processes and ends with the dispatch of the finished product. Strict controls, conducted according to the legal provisions and specific standards, accompany the product. Ongoing quality training ensures that our employees are informed about the applications of our products and the quality requirements placed on them.
All products can be traced back to their production period, machine operators and tools, all the way back to the starting materials used.
With each delivery of high quality goods, our customers receive a quality certificate and a guatantee of performance which commits us to maintaining our high quality standards.