Writing quality SOP for work infrastructure

In SOP for infrastructure you need to consider the following:

• Description of the buildings, workspace, and associated utilities
• What kind of the process equipment you have (both hardware and software)
• What kind of supporting service you have

More information on this topic you can find in the following article:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/

You can also see how the procedures for infrastructure and records of the infrastructure maintenance in our ISO 13485:2016 documentation toolkit look like:

• Procedure for Infrastructure and Work Environment https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/
• Record of Infrastructure Maintenance https://advisera.com/13485academy/documentation/record-of-infrastructure-maintenance-iso-13485-2016/