Product manufacturing checklist.

(2) Product manufacturing checklist. Manufacturers shall require an ISO-certified auditor to complete a Product Manufacturing Checklist (figure E-2 of this subpart), which evaluates the manufacturer on its ability to meet the requirements of the standard in maintaining quality control in the production of FRM or FEM devices. The completed checklist shall be submitted with the application for FRM or FEM determination.


40 CFR § 53.51

Scoping language

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