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HOSPITEX DIAGNOSTICS CERTIFICATION
Certified by 1999, Hospitex Diagnostics now complies with ISO 9001:2008 standards and, by July 2009, also with ISO 13485:2003.

ISO 9001:2008 procedures regard Quality Management System, Management Responsibility, Resource Management and Product Realization. And from The improved and smooth ISO 9001 Certified Quality System enables our company to meet the new market requirements such as taking the instruction from the customer, the design and development of products, the purchasing of materials and services and the delivery of the products and services with maximum Quality.

From July 2009 Hospitex Diagnostics proudly complies also with ISO 13485:2003. This certification represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

The compliance with ISO 13485:2003 and ISO 9001:2008 is an important step for achieving full compliance with European regulations.

Main features of the new interpreted quality system are:
• Detailed risk analysis
• Communication and information to the customers
• Management of product and lot traceability
• Company management system
• Process control

Actually part of the products are international CE certified.

Additionally some of our goods are registered and certified in specific countries, where specific laws are enforced.
   ISO 9001 from CISQ              ISO 9001 from IQNET              ISO 13485:2003

To receive CE or other countries certificates, please contact our main office.