Hi! Covers,
The Standard did not mention what data, so I think it is depends on the user ( Manufacturer) to determine what data will be used for the purpose of analysis, so long as it is improving or reduce the defective rate for any processes.
Correct me if I have away! :mg:
This is true to an extent. The standard does not say specifically what data should be analyzed, but it does tell about data types that need to be analyzed, including data related to suppliers. Most people will track defect rates, or scrap or something like that, and completely forget the other required areas of data analysis. Feedback is also an area that is overlooked in smapper organizations. People assume if they are reporting adverse events they are OK, but they also need to trend and analyze these.
Remember, the goal with 13485 is not continuous improvement, but safety and effectiveness, or efficacy. So while you want to make improvements where you see them, that is not always going to be the goal of data analysis. It is more important to show you are correcting issues you see in the data than showing how you use it to improve a process. Hope this helps a little.