I'm a part of an organization that is moving to ISO 13485:2016. We currently do NOT have an lms which is troublesome. How do we track self-training using paper training forms, then be able to justify training was effective? I have years of experience with lms', but in this company we are relying on spreadsheets and paper.
Any insight would be gratefully appreciated.
I'm presuming the training form you mention is simply something that has the person's name and position, along with the training material/subject and date. If this presumption of mine is true, then what you have is simply a (self) declaration of qualification; it has very little to do with the effectiveness of the training.
Most processes have metrics or ways of measuring their results.
Let's say you were training people on an improvement to the process of making widgets - say a new piece of equipment that is faster and more accurate. By measuring and monitoring items such as utilization, defective product, machine uptime, etc., you can assess training effectiveness. If, for example, the % of defective products remained unchanged (or worsened), perhaps the people were not effectively trained on how to properly use the new machine.
This type of assessment on the effectiveness of training could take some time.
If you're looking for a more immediate evaluation of training effectiveness, you could implement tests at the end of training on priority processes. I'm not a huge fan of this approach as I find it's more about evaluating short-term memory than actual application of the training.