Ok... another newbee question
I recently started working for a new company which product is a medical device, for the time-being, limited to software. We are preparing for ISO 13485 audit.
The manufacturing process for the software has not been decided completely yet (outsourced or not). Manufacturing process, for us, "simply" imply burning cd, label & pack... I am doing a procedure for purchased products verification but I am having trouble defining stats variables. I do understand (or think I am) the AQL but I cannot understand how you can determine the sample size regardless of the population size (or size of the lot). Doesn't the sample size should vary with the size of the lot and the quality assured by the manufacturer?
Thanks for your help...