A quality assurance
The Bilicrystal meets several certificates which are shown hereafter.
1. ISO 9001
ISO 9001 (International Standard Organisation) determines a model for the quality in conception, development, production, installation, and the associated services(like after-sales)of any given product. That means that this certificate 9001 is for that develop and manufacture specific products.
In Belgium several organisations accredited by the government are able the hand out this certificate after an extensive audit of the company. Medestime was credited ISO 9001 on 14/07/1998.
2. EN 46001
The EN 46001 norm is as important as ISO certification. This certification differs from the ISO norm only on the point that it is specifically for medical products. This certification was also obtained on 14/07/1998.
3.Ce marking
This marking assures the conformity of the product with the European demands. Although we received this marking last, it is by no means the least one. It was extremely hard to obtain such certificate, and the procedure has taken 18 months. The CE marking for the second generation Bilicrystal dates from 25/07/2001.
