Quality Assurance

SonoSite’s quality vision is simple:

Our job is to anticipate and meet our customers’ requirements through continuous

improvement in every aspect of our business practices.

  • The quality assurance management system that supports the design, development, manufacture, testing and release of SonoSite products is comprehensive, robust and meets the requirements of both regulatory agencies and customers.
  • SonoSite products are designed and manufactured in accordance with established United States FDA quality system regulations (21 CFR 820) and other international quality system standards including ISO 13485:2003 and ISO 9001-2000.
  • SonoSite product designs are verified and validated and meet design input requirements and specifications, intended uses, and user needs.
  • The materials used to manufacture SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).
  • Delivered SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).

Harmonized Standards
European harmonized standards that each SonoSite-marked product complies with are listed below.