1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?
2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?
We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?
I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.