Quality System Certification
Spencer works in the emergency market, where the requirement of high technology and easy to use products obliges companies to structure in promptly with qualified and efficient organization strategies. Therefore Spencer has based its company’s order upon two important strategy factors:
- The certification of its own Quality Assurance System, according to ISO 9001:2000 norms (certificate n. 501003950-Rev.01/A) and UNI CEI EN ISO 13485:2002 (certificate n. 501003950-Rev.01/B), issued by TÜV Product Service GmbH, Germany
- Research and development for studying the realization of technologically advanced devices
For all the medical devices produced by the company, the CE marking procedure has been carried out in respect of the essential requirements contemplated in the European Directive 93/42/CE.
Besides, the company has obtained the NATO and FDA certifications for many products and have been registered for sale in different countries, such as Poland, Russia, Romania, Turkey, Lithuania, Latvia, Canada.