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This is probably a dumb question, but I'm going to ask it anyways.
Can anyone explain to me if the procedures that are used to manufacture a device (those in the DMR) are a subset of the Quality Management System? In other words, when someone refers to "Quality System processes" would this this include those DMR manufacturing procedures specific to a product (such as the assembly SOP), or is it seen as being separate?
For instance: 820.100.2 states: "Investigating the cause of nonconformities relating to product, processes, and the quality system;" What processes differ from those in the the quality system?
Thanks!
Can anyone explain to me if the procedures that are used to manufacture a device (those in the DMR) are a subset of the Quality Management System? In other words, when someone refers to "Quality System processes" would this this include those DMR manufacturing procedures specific to a product (such as the assembly SOP), or is it seen as being separate?
For instance: 820.100.2 states: "Investigating the cause of nonconformities relating to product, processes, and the quality system;" What processes differ from those in the the quality system?
Thanks!
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