21 CFR § 1.615 General Enforcement Regulations

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

Current through Sep 8, 2026 · Read all of Part 1

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.

← § 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?§ 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation? →