{"data":{"id":"us/21-cfr-1.622","jurisdiction":"us","citation":"21 CFR 1.622","heading":"How must a recognized accreditation body monitor its own performance?","body":"(a) A recognized accreditation body must annually, and as required under § 1.664(g), conduct a self-assessment that includes evaluation of compliance with this subpart, including:\n(1) The performance of its officers, employees, or other agents involved in accreditation activities and the degree of consistency in conducting accreditation activities;\n(2) The compliance of the recognized accreditation body and its officers, employees, and other agents involved in accreditation activities, with the conflict of interest requirements of § 1.624; and\n(3) If requested by FDA, any other aspects of its performance relevant to a determination whether the recognized accreditation body is in compliance with this subpart.\n(b) As a means to evaluate the recognized accreditation body's performance, the self-assessment must include onsite observation of regulatory audits of a representative sample of third-party certification bodies it accredited under this subpart. In meeting this requirement, the recognized accreditation body may use the results of onsite observations performed under § 1.621(b).\n(c) Based on the evaluations conducted under paragraphs (a) and (b) of this section, the recognized accreditation body must:\n(1) Identify any area(s) where deficiencies exist;\n(2) Quickly implement corrective action(s) that effectively address those deficiencies; and\n(3) Establish and maintain records of any such corrective action(s) under § 1.625.\n(d) The recognized accreditation body must prepare, and as required by § 1.623(b) submit, a written report of the results of its self-assessment that includes the following elements. Documentation of conformance to ISO/IEC 17011:2004 may be used, supplemented as necessary, in meeting the requirements of this paragraph.\n(1) A description of any corrective actions taken under paragraph (c) of this section;\n(2) A statement disclosing the extent to which the recognized accreditation body, and its officers, employees, and other agents involved in accreditation activities, complied with the conflict of interest requirements in § 1.624; and\n(3) A statement attesting to the extent to which the recognized accreditation body complied with applicable requirements of this subpart.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 1—GENERAL ENFORCEMENT REGULATIONS","Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"488664938ab9e89f42604f5b925abd11972cbedf44ec2e1581c07f36254cc161","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1.621","next":"us/21-cfr-1.623"},"notice":"GroundRules: Original legal text. Not legal advice."}