§1.644. What quality assurance procedures must a third-party certification body have to qualify for accreditation?
21 C.F.R. § 1.644
A third-party certification body seeking accreditation must demonstrate that it has:
Implemented a written program for monitoring and evaluating the performance of its officers, employees, and other agents involved in auditing and certification activities, including procedures to:
Identify deficiencies in its auditing and certification program or performance; and
Quickly execute corrective actions that effectively address any identified deficiencies; and
The capability to meet the quality assurance requirements of § 1.655, if accredited.
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.