7. What is the difference between ISO 13485 Certification
and Accreditation ?
• Certification – the provision by an independent
Organization of written assurance (a certificate) that
the product, service or system in question meets
specific requirements.
• Accreditation – the formal recognition by an
independent Organization, generally known as an
accreditation board, that a certification body operates
according to international standards.
8. Precaution regarding Displaying your ISO 13485 Certification
• Remember, when labelling a product or system as
certified to an ISO standard:
• Do not claim: "ISO certified" or "ISO certification"
• DO say: “ISO 13485 Certified Organization" (for
example).