IHE International Conformity Assessment Continuum IHE International Scheme

IHE International Conformity Assessment Continuum IHE International (Scheme Owner) R I G O R IHE Connectathon Testing Vendor Capability Product IHE Integration Statement Development / Systems Product Accredited Testing (ISO 17025: 2005) Certification (ISO 17065) Products and Specific Versions

Conformity Assessment Infrastructure for IHE International Roles to deliver IHE Conformity Assessment Roles IHE International IHE National or Regional Deployment Committee • • • Scheme Owner, based on Technical Frameworks Publishes Test Criteria Responsible for Testing Lab Accreditation Coordinate Test tool development ISO 17025 Accredited Testing Lab(s) • Select Testing Lab(s) • Required by all IHE Conformity Assessment Programs worldwide • Separate, but complementary to Connectathon testing • Contribute to test tool and test criteria development • Provides IHE Testing Mark ISO 17065 Accredited Certification Body • Optional – based on individual Deployment Committee requirements • Evaluates and grants Certification within a country(s)/region(s) Accredited to Scheme held by IHE International Maintains ISO 17025 accreditation Utilizes Gazelle Test Management System and Reference Implementations and Simulators Utilizes Test Scripts Provides Accredited Testing Reports Optionally Provides testing Report to Certification Body