Quality Management System

Certified Quality Management System

Blue Ocean is proud of its BSI Certificate of Registration certifying that its Quality Management System complies with the requirements of ISO 13485 and Good Manufacturing Practices (GMP).  The ISO international standard specifies the requirements for a quality management system to be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.  This ISO certification demonstrates the company’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.