JIS Q 13485:1998

This Standard specifies, in conjunction with JIS Z 9901, the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices. This Standard, in conjunction with JIS Z 9901, is applicable when there is a need to a assess a medical device supplier's quality system. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.