An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it meets the requirements of §§ 1.611 through 1.615 . The accreditation body may use documentation of conformance with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17011:2004, supplemented as necessary, in meeting the applicable requirements of this subpart.
21 C.F.R. §1.610