STD Items

Standards Items are used to perform a gap analysis between the QMS and requirements of a specific standard.

To start with, the requirements of ISO 13485:2016 are listed and the gap analysis is already completed.

You should verify that this is correct for your organization and if needed, add links to new/other processes or remove processes.

Adding links to PROC items

In existing STD items, a link to a PROC item can be created by either clicking on Create Process or Select Existing.

Creating new Gap Analyses

If you want to add requirements of another standard, you can go to the main category folder (STD in this case) and click on Create Standards.

This will allow you to create a new STD item.