QM System Certification ISO13485 (ISO9001)
ISO 13485 is an international standard for quality management system which specifies the requirements for the design and development, manufacturing, installation and servicing of medical devices. Establishing and operating a quality management system conforming to the standard ensures the safety and effectiveness of the medical devices provided by the organization.
Many countries, including European countries, Canada, South Korea, Taiwan and Australia have implemented the ISO 13485 certification as regulatory requirements for medical devices. Japan has also adopted the concept of the standard into the QMS Ordinance.
Hence, the ISO 13485 certification is not only proof that the QM system established by the medical device provider conforms to the regulatory requirements, but also a crucial passport to enter the global market.
The TÜV-SÜD GROUP is an international third-party certification organization. TÜV-SÜD Product Service is a member of the group and a Certification and Notified Body accredited by the German accreditation organization, ZLG. In Japan, ISO 13485 audit and certification services are provided through the MHS Department of TÜV-SÜD Japan.
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TÜV-SÜD Japan employees a large number of auditors who are specialized in providing ISO 13485 certification services and who will provide you with immense support in obtaining ISO certification. You can also obtain other certifications for other standards or regulations at the same time as you obtain ISO 13485 certification.
Please contact TÜV-SÜD Japan when considering obtaining ISO 13485 certification.
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