An ISO
9001:2000 certificate proves that your Quality Management System
has been certified against a best practice standard and found
compliant. Issued by a third party certification body/registrar, the
certificate lets customers know they can trust that you have
implemented the necessary internal processes to meet obligations.
ISO
13485:2003
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.