Thursday, November 11, 2010

Quality and Safety Standards that Apply to Health Software

I have been researching the various standards that may be considered in upcoming discussions about the ISO TC215 technical report on software and patient safety. Over the next days and weeks I'll email you with any interesting tidbits I uncover that may stimulate discussion. The actual standards themselves are quite expensive so I will provide wikipedia or SCC catalogue references to start you on your own research paths. Comments/reactions are most welcome.

Are there any other standards you think might apply?

To start - Standards in play:

ISO 13485 - Medical devices —— Quality management systems —— Requirements for regulatory purposes

ISO 14969 - Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003

ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices

IEC 62304 - Medical Device Software - Software Lifecycle Processes

ISO 9001 - Quality Management Systems

ISO 90003 - Software engineering Guidelines for the application of ISO 9001:2000 to computer software

ISO 25238 - Health Informatics - Classification of safety risks from health software

ISO 27809 - Health Informatics - Measures for ensuring patient safety of health software

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