1. 4.1.6 What software needs to follow the software validation process? Would smartsheet or excel have to be validated?
You need to perform validation for any software that is being used in the quality system together with evaluation the risk of each of those applicable pieces of software. This assessment can include databases, Solidworks/CAD files for design activities, issue tracking software, complaint management software or CRM systems, ERP systems, and/or distribution software programs. The evaluation process should be documented, and the results should be tied to actions. You do not need to perform validation of smartsheets and excel.
For more information, please read the following articles:
How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
2. We do not only manufacture medical-related products. We produce thermoplastics. Is it ok for us not to use a risk management procedure on non-medical if specifically called out in the procedure?
Yes, it is ok not to use risk management procedure on non-medical devices.