ISO 13485/13488 are standards specific to medical device quality systems that supplement the ISO 9001 standard. Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or ISO 13488 after January 2003.

ISO 9001 / ISO 13485 - Who is certified to these standards?

• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
• Consultants which design, manufacture, and assemble medical and in vitro diagnostic medical devices.
• Medical component manufacturers.
• Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

About ISO 13485 & ISO 13488

The title of the ISO 13485 and ISO 13488 standards are as follows:

• ISO 13485:1996: Quality systems - Medical devices - Particular requirements for the application of ISO 9001.
• ISO 13488:1996: Quality systems - Medical devices - Particular requirements for the application of ISO 9002.

The ISO standards are copyrighted material and must be purchased from an approved vendor.

What is the difference between ISO 13485 and ISO 13488?

• ISO 9001, ISO 13485 and EN 46001 are applicable to manufacturers and service providers that perform their own design activities.
• ISO 9002, ISO 13488 and EN 46002 are for manufacturers and service providers without design activities.