I need help! OK I can read the standard OK ( I think) but not sure how to handle this aspect of what we do. We are a design and manufacturing company, our own designs. But the process is really like this: I had an idea after a beer last night , lets write down what we want to do, lets experiment and build prototypes, test the theory out, then prove it works and if it does lets get on an build and sell it. When should 9001 kick in and how should I document the change over? After we are sure it all works we can have real design input and the system can have change notes and other great things but before that we might have 20 changes a day and a formal change system can not stand in the way of research. It’s not just design though. We have a supplier selection process but in the research phase suppliers change often but the PO system, or storage system, can not differentiate between bits bought for products in the main production cycle or those we bought from ebay, or that company we thought could make this special bit in the research phase. Sorry for rambling on. Last time I had this challenge it was in a medium sized company and it was easy to exclude research from the scope but in a 5 man outfit its not quite as simple Suggestions, questions, and comment most welcome.