1) A company has several sites all over the world. One site, in Sweden, has a design authority. They buy hours for design service from one of the American sites. This site has excluded the clause 8.3 in their scope. Should they? They work in the Swedish design system.
Clause 8.3, Design and development of products and services, is intended to be the process that you use for planning the products and services you provide in order to meet all the requirements for those products and services. So if your service is, for instance, to “design drawings” then this is the service you provide and if this service is already developed you could exclude clause 8.3 from your QMS. You are simply providing a service that is part of another company’s design and development process. The process that you use to provide the “design service” would be controlled under clause 8.5, Product and service provision.
2) The same American company is also selling design service in form of hours to an OEM in US. Using the OEM's design system. If it is mil itary parts, are the rules that the selling site has to have an US citizen manager? The engineers doing the work are US citizens.
Answer: This is a legal requirement that is outside of the AS9100 Rev D requirements. For this answer you would need to ask the customer what legal requirements they are imposing on the service you provide. If the legal requirements is ITAR related, there can be limitations on the citizenship of those working on the service, but your customer would need to clarify this.