Most reputable medical device design and manufacturing companies are certified to ISO 13485:2003, but few take the added and more rigorous step of obtaining the ISO 9001:2008 certification. RBC Medical Innovations took this additional step because we believe that continuous improvement and customer satisfaction, the differentiators of ISO 9001:2008, are required to consistently innovate in medical devices industry.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001:2008 that are not appropriate as regulatory requirements.
A fundamental difference, however, is that ISO 9001:2008 requires the organization to demonstrate continuous improvement, whereas ISO 13485:2003 requires only that they demonstrate the quality system is implemented and maintained.
By partnering with RBC Medical Innovations, you’re engaging with a company that treats quality management as an on-going, continuous improvement process and not just a certification of excellence.