ISO 13485:2003 Certification

Scientific-and-Production Firm VD MAIS has been successfully certificated of its quality management system conformity with ISO 13485:2003. Meeting the standard specified requirements for corporate QM system has been proven for such types of activities as design and development, production and distribution of electronic modules and PCBs, components or systems to be used in medical devices and apparatus.

ISO 13485 is an international industry standard, developed by the International Standardization Organization (ISO). The standard establishes requirements for the quality management system of medical devices manufacturers and is a complementary to technical requirements for the products. The standard provides regulatory requirements for companies and organizations involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

Compliance with the ISO 13485 requirements correlates with the VD MAIS market strategy in part of expanding its leadership as an EMS provider for different industries.

An external auditing at the certification process was provided by Quality Austria – Trainings, Zertifizierungs und Begutachtungs GmbH,  an accredited organization from Vienna, Austria.

Thus VD MAIS has made one more step in providing full range of certificated and dully organized Electronic Manufacturing Services for its clients in Ukraine and other European countries.

For details of certificated activities, references or requests do not hesitate to contact EMS Department or Electronic Components Department of VD MAIS by e-mail, post, fax or phone.