21 CFR 1.615 - What records procedures must an accreditation body have to qualify for recognition?

Regulations last checked for updates: May 16, 2024

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

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

§ 1.615 - What records procedures must an accreditation body have to qualify for recognition?

An accreditation body seeking recognition must demonstrate that it has:

(a) Implemented written procedures to establish, control, and retain records (including documents and data) for the period of time necessary to meet its contractual and legal obligations pertaining to this subpart and to provide an adequate basis for evaluating its program and performance; and

(b) The capability to meet the applicable reporting and notification 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 1.615