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Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13845 quality system


Alpha Quality Assurance Associates
111 Nataqua Avenue
Pacifica, CA 94044
Phone 650.359.4297
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ISO 13485:2003 Quality Management System Requirements


ISO 13485 consultant from Alpha Quality AssuranceISO 13485 is a medical device quality systems standard that supplements ISO 9001. The additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.


ISO 13485 is not a product standard, but a process standard. A quality system that complies with the ISO 13485 standard is insufficient; you must also comply with all relevant product and service oriented technical standards and regulations.

Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13485 quality system.

What is the difference between ISO 13485 and ISO 13488?

ISO 9001, ISO 13485 and EN 46001 are applicable to manufacturers and service providers that perform their own design activities. ISO 9002, ISO 13488 and EN 46002 are for manufacturers and service providers without design activities.

Who can be certified to ISO 13485:2003?

  • Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union
  • Consultants that design, manufacture, and assemble medical and in vitro diagnostic medical devices.
  • Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.



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