You can make also a GAP analysis between ISO 9001 and ISO 13485 if you have implemented a quality management system according to the ISO 9001:2015 and you need now to implement ISO 13485:2016. The best way to conduct this GAP analysis is to take a cross-references table at the end of the ISO 13485:2016 standard (Annex B).
2. How to determine key performance indicators?
The term Key Performance Indicator refers to measurements you used to determine the performance and effectiveness of the QMS. This is completely up to you, but the main question you need to ask yourself is "What do I need to measure to know that my QMS processes are performing as expected and that they are effective?". KPIs also depend on what is a company’s strategy and competitive advantage. KPIs for a manufacturer of commodities are different from a manufacturer of innovative or differentiated stuff.
For more information regarding the KPI, please see the following article, regardless of what is their mention of the ISO 9001 standard: