qualifying activity

(1) The organizational element that grants certification status; this element may be a part of a) the acquiring activity; b) a quality organization within the manufacturer's company that is independent of the group(s) responsible for the device production, screening, and marketing; or c) an independent third-party organization.

(2) The organizational element of the government that grants certification and QML status.

References

JEP133B, 3/05

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