QS Standards
AAMI Standards
AAMI is the first source for medical device standards and technical documents. Several of AAMI's standards are particularly relevant to the Quality System. Links to these documents are provided below:
- ANSI/AAMI/ISO 13485:2003(R)2009 Medical devices - Quality management systems - Requirements for regulatory purposes
- ANSI/AAMI/ISO TIR 14969:2004 Medical devices-Quality management systems-Guidance for the application of ISO 13485:2003
- ANSI/AAMI/ISO 14971:2007(R)2010 Medical devices-Application of risk management to medical devices
- ANSI/AAMI/IEC TIR 80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- ANSI/AAMI/IEC 62304:2006 Medical device software-Software life cycle processes
- AAMI TIR32:2004 Medical Device Software Risk Management
- ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
Other Standards
ISO and IEC have standards that have not been adopted by AAMI, but are still relevant for Quality Systems professionals. Links to these websites are provided below:
- ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
- ISO 19011:2011 Guidelines for auditing
- ISO 9001:2008 Quality management systems - Requirements
This standard is being revised. Please visit www.asq.org for more information on this document's status.