R
REOQA
I work for a ISO 13485 certified small medical device contract manufacturer. We would like to implement the Training Within Industry modules of JI, JR, and JM. I would appreciate some help from someone else who is 13485 certified and using TWI. I am unsure of how to proceed with documentation requirements concerning the job breakdown sheets, training plan (or training matrix) and observation checksheets. Does it really require an engineering change to create and then modify these documents?
Regards,
Jim
Regards,
Jim