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

You need to document requirements for the maintenance activities and with what kind of records you will prove that those maintenance requirements are fulfilled.

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/