[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.22]

[Page 155-156]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820_QUALITY SYSTEM REGULATION--Table of Contents
 
                  Subpart B_Quality System Requirements
 
Sec. 820.22  Quality audit.

    Each manufacturer shall establish procedures for quality audits and 
conduct such audits to assure that the

[[Page 156]]

quality system is in compliance with the established quality system 
requirements and to determine the effectiveness of the quality system. 
Quality audits shall be conducted by individuals who do not have direct 
responsibility for the matters being audited. Corrective action(s), 
including a reaudit of deficient matters, shall be taken when necessary. 
A report of the results of each quality audit, and reaudit(s) where 
taken, shall be made and such reports shall be reviewed by management 
having responsibility for the matters audited. The dates and results of 
quality audits and reaudits shall be documented.