21 CFR 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition?

Regulations last checked for updates: May 15, 2024

Title 21 - Food and Drugs last revised: May 06, 2024

View all text of Subpart M [§ 1.600 - § 1.725]

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

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.

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; 42 U.S.C. 216,241,243,262,264,271

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

cite as: 21 CFR 1.614