In 1993, we earned certification for ISO 9001, an international quality management system standard, and for ISO 13485:1996, another international quality management system standard for medical equipment. On April 1, 2005, we were certified by TÜV Management Service GmbH, a German organization, for ISO 9001:2000 and ISO 13485:2003.
Now we earned certification for ISO 9001:2008 on April 1, 2009.
Our quality management system is structured to include Rion Company, and its manufacturing subsidiaries of Tohoku Rion Company and Rion Techno Company. This certification acquired at this time applies to both subsidiary companies.
ISO 13485:2003 constitutes the base of requirements of the Pharmaceutical Affairs Law of Japan, as amended, and EU Council Directive (93/42/EEC), and is a quality management system which aims to regulate quality of medical equipment such as hearing aids and audiometers that are groups of our main products. In addition, the same service organization as above certified our hearing aids on April 1, 2005 as meeting the requirements of CE marking (full quality assurance system).
It is our firm commitment to continue our efforts to improve the effectiveness of our quality management system with this certification as a springboard and proceed development of new products to even better serve our customers.
Terms
1. EU Council Directive 93/42/EEC (Medical Device Directive)
This EU Directive is applicable to instruments, apparatus, appliances, materials or other article to be used for human beings and defines basic requirements, protective measures for health and safety, classification, field incidents reports, conformity assessment procedures, clinical testing, designated organizations and CE marking requirements, including Annexes I through XII. This Directive is applicable to CE marked medical devices for export to the EEA (EU + EFTA).
2. ISO 13485:2003 Quality Management System - Medical devices
This is an international standard defined to aid worldwide establishment of a quality management system in the medical device industry in respective countries, and has been introduced or is being introduced as regulatory requirements in more and more countries. The establishment of this standard, the initial publication of which took place in July 2003, is on the basis of ISO 9001:2000, with additional requirements specific to medical devices. "Customer satisfaction" and "continuous improvement" which are new to ISO 9001:2000 are cited in this ISO 13485 as "customer focus" and "maintenance of adequacy and effectiveness" because they were considered as being out of harmony with medical devices.
In Japan, the Pharmaceutical Affairs Law, as amended, which was put into effect on April 1, 2005, requires manufacturers and sales companies of medical devices to implement a quality management system comparable to that identified in ISO 13485:2003.
3. CE marking, EC Declaration of Conformity (full quality assurance system)
Affixation of a CE marking on medical devices is subject to declaration of conformity with the EU Directive for medical devices, 93/42/EEC.
For declaration of conformity, several rules are involved. They are dependent not on product verification but approval of a quality system for design, manufacture and final inspection.
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