[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.186]

[Page 149]
 
                        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 M--Records
 
Sec. 820.186  Quality system record.

    Each manufacturer shall maintain a quality system record (QSR). The 
QSR shall include, or refer to the location of, procedures and the 
documentation of activities required by this part that are not specific 
to a particular type of device(s), including, but not limited to, the 
records required by Sec. 820.20. Each manufacturer shall ensure that the 
QSR is prepared and approved in accordance with Sec. 820.40.