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).
- EC Certificate (PDF)
- EC Certificate - L25 Needle Guide (PDF)
- ISO 13485:2003 (Includes CMDCAS certification for Canada) (PDF)
- ISO 9001:2008 (PDF)
European harmonized standards that each SonoSite-marked product complies with are listed below.
|980||Graphical symbols for use in the labeling of medical devices (2008)|
|1041||Information supplied by the manufacturer with medical devices (2008)|
|ISO 13485||Medical devices / Quality management systems / Requirements for regulatory purposes (2003)|
|ISO 14971||Medical devices / Application of risk management to medical devices (2007) (ISO 14971:2007) (Superseded standard: EN 1441)|
|ISO 10993-1||Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1 series)|
|60601-1 A1-A2||Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991/A2:1995 + corrigendum June 1995|
|60601-1-4||Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems (IEC 60601-1-4 Ed. 1.1 b:2000)|
|ISO 11135 series||Sterilization of Health Care Products (Ethylene Oxide)|
|ISO 11137 series||Sterilization of Health Care Products (Radiation)|
|60601-2-18||Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18 Ed. 3.0 b:2009)|
|60601-2-22||Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22 Ed. 3.0 b:2007)|
|60601-2-25||Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25 Ed. 1.0 b:1993)|
|60601-2-27||Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27 Ed. 2.0 b:2005)|
|60601-1-1||Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (2001) (IEC 601-1-1:2001)|
|60601-1-2||Medical electrical equipment / Part 1: General requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests (2001) (IEC 60601-1-2:2001)|
|60601-2-37||Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001) (IEC 60601-2-37:2001)|