I agree with most of the participants in the above posts. During my senior design class at NJIT, I learned more about the requirement and the test method documents and its importance. My professor constantly stressed every class that the requirement and the test plan document must be “idiot proof” and easy to understand. Requirement document has specific details from the end user or the customer and test plan consists of steps of multiple tests to prove each customer requirement. Both of the documents must be very detailed so if someone’s to test for each requirement, he or she should be able to perform without any assistance. In my industry experience, I’ve found this very helpful. For example, there are inspection plans for each operation of the manufacturing process to test the requirements. The inspectors must be able to test the part with the applicable test methods written on the inspection plan. The Quality Engineers creating the test plans are very detailed as they are busy supporting other activities throughout the day. To summarize, all documents must be clear and detailed in the medical device industry, it also makes it easy for Quality Manager to explain in an audit.