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Notes

§1.614. What quality assurance procedures must an accreditation body have to qualify for recognition?

21 C.F.R. § 1.614

An accreditation body seeking recognition must demonstrate that it has:
(a)
Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents and its accreditation program, including procedures to:
(1)
Identify areas in its accreditation program or performance where deficiencies exist; and
(2)
Quickly execute corrective actions that effectively address deficiencies when identified; and
(b)
The capability to meet the applicable quality assurance requirements of this subpart, if recognized.
Notes, amendments, and revision history

Source

Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.

Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.