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 FDAi quality system regulations (21 CFR 820) and other international quality system standards including ISOi 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).
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EC Certificate (PDF)
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EC Certificate - L25 Needle Guide (PDF)
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ISO 13485:2003 (Includes CMDCAS certification for Canada) (PDF)
- ISO 9001:2008 (PDF)
Harmonized Standards
European harmonized standards that each SonoSite-marked product complies with are listed below.