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).

• EC Certificate (PDF)
   
• EC Certificate - L25 Needle Guide (PDF) 
   
• 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.