Hello, I work with a transportation company that ships cargo via road/rail/vessels. Currently we have an exclusion to 8.3 Design and development. However, I don't know how we were able to justify this. We own some of our shipping containers and retrofit them depending on the season (heated/dry/refrigerated) and carry out this work our self or sub contract this out. In addition, some of our containers are specifically designed based on the commodity for specific clients, we work with the client to determine the requirements and would contract the build out. Also, the movement of some of the cargo is completely dependent on the customer requirements, we may make different arrangements to satisfy the needs of the customer or consignee. Wouldn't design and development be applicable to our processes? I have only been with this company as their Quality Management Coordinator for half a year. I am currently rewriting the scope of our QMS to make it more applicable to the current QMS. I am not sure if we can really justify the exclusion/applicability of 8.3. Comments are greatly appreciated!