That is correct, there is a fairly exhaustive process to achieve compliance, including simple things like lot tracking and more complex items ranging from failure root cause analysis and tracking, and equipment maintenance/calibration logs and ability to track every component from supplier through manufacturing process including which mill is used and the tool records and Ac process with designated responsible individuals and the standards they certify it meets.
Basically a client can be provided the tracking of every step of the manufacture, of every component that went into a case, and the validations that every piece of equipment was used properly and that the results met a verifiable standard which was examined and documented by a Qc tech who was authorized to make such determinations.