The certification to ISO 13485 provides manufacturers and suppliers of medical devices beneficial operational improvements in the same way as with ISO 9001. It is essential for many medical companies, which export their products to the global market.

What does each standard mean?

ISO 9001 is a quality system standard applicable to many industries. ISO 13485 is a standard specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.

ISO 13485 - Who is it applicable to?

Firms who currently manufacture private label medical devices, who may eventually want to place these devices under their name on the market in the European Union under their own name.

Consultants, which design, manufacture, and assemble medical and in vitro diagnostic medical devices.

Companies who manufacture Medical components.

Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.