Quality Management
Fukuda enhance its manufacturing technology to continue to maintain outstanding quality of its products with minimal impact on the environment.
Since its foundation, Fukuda has been dedicated to delivering the highest quality and therefore operates a strict quality control system. In recent years, as people have become increasingly safety-cautious concerning medical treatment, Fukuda has drawn up plans to broaden and reinforce its quality control system, basing its own quality system on the Zero Complaint Concept.
ISO 9001
ISO 9001 is a recognized international standard that specifies requirements for a quality management system, from design and development to production, inspection, shipping and servicing of a product, established by the ISO (International Organization for Standardization).
We, Fukuda Denshi Co., Ltd., have obtained certification of ISO 9001 in 1995 through the British Standards Institution (BSI). We have also been focusing on establishing an international quality management system, such as by obtaining certifications based on the European Medical Device Directive (93/42/EEC), ISO 13485, and the Canadian Medical Devices Conformity Assessment System (CMDCAS). Under our quality policy, we continue to work for quality assurance activities with strict standards, putting effort into the development of products that are trusted by all of our users.
Scope of Certification
The design, development, manufacture, sales, in-house repair, servicing, storage and final staging for distribution of measuring equipment for vital signs and monitoring equipment for vital signs, electrocardiographs, defibrillators, ultrasound imaging systems, oxygen concentrators and associated accessories.
ISO 14001 (Fukuda Denshi's Shiroi Factory Only)
Fukuda Denshi's Shiroi Factory has been performing activities based on ISO 14001 (a recognized international standard that specifies requirements for an environmental management system) as part of the approach to reduce environmental burdens arising from industrial activities and to protect the environment. Our factory has obtained certification based on ISO 14001:1996 through BSI Japan in June, 2003. Then, in June, 2005, our accreditation has been renewed to ISO 14001:2004 (the latest version of the ISO 14001 standard). We will continue to perform environmentally-friendly activities based on our environmental policy.
BSI (the British Standards Institution)
BSI is responsible for the development of the British Standards. BSI not only promotes standardization in wide industrial fields, but also plays a main roll in CEN/CENELEC's establishment of the European Norm along with DIN and AFNOR, and in the international standardization activities of the ISO/IEC. In addition to developing standards, BSI also performs activities such as quality certification, product inspection, and technical support to exporters, and is one of the certification bodies for ISO 9000 in the UK.
http://www.bsigroup.com/
