ISO 13485:2003 Certificate PC CCB program Chemistry
Alkaloid AD Profit Center Chemicals Cosmetics and Botanicals’ program Chemistry - Medical Appliances, has acquired the Certificate for its management system by implementing and meeting the requirements of ISO 13485:2003.
The scope of this Certificate refers to the design, development, production and distribution of medical appliances: X-ray films and concentrated haemodialysis solutions, as well as subcontracted production, packaging, labeling and distribution of cartridges for haemodialysis and X-ray film developer liquid and fixers.
The Certificate was issued in July 2011, and the audit was performed by the renowned certification body DEKRA Certification B.V. from the Netherlands, one of the major certification bodies worldwide. The quality, know-how and services of DEKRA Certification B.V are a benchmark for quality of medical appliances production.
With this Certificate Alkaloid continues to build solid grounds for conquering new European markets with this product portfolio.