by
Barbara Kram, Editor | February 13, 2008
ISO 13485:2003
certification for
medical devices
Ambassador Medical has received ISO 13485:2003 certification as a Refurbisher of ultrasound equipment by BSI Management Systems. This certification serves as recognition of Ambassador's Quality System in meeting the requirements of the International Quality Standard for Medical Devices.
"This was an immense effort by the entire team," said Patricia Seguim-Arnold, Site Quality Leader for Ambassador Medical. "From a quality point of view it validates our system and shows that we are doing the right things for our customers and the patients they serve."
In order to gain the distinction, a BSI certification body toured Ambassador's facility to assess the company's systems in terms of the ISO quality management standards. These include overall quality, management, technical issues, processes, customer service and other parameters that comprise quality management excellence. Ambassador Medical's certificate is for refurbishment in particular, however the standard pertains to medical devices overall.

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"We want to use it as a differentiator to show our commitment and dedication to providing not only quality products but service and the management piece [throughout] the entire organization," said
Christine J. Wright, Director of Marketing and Business Development.