[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.20]

[Page 141]
 
                        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. 820.20  Management responsibility.


    (a) Quality policy. Management with executive responsibility shall 
establish its policy and objectives for, and commitment to, quality. 
Management with executive responsibility shall ensure that the quality 
policy is understood, implemented, and maintained at all levels of the 
organization.
    (b) Organization. Each manufacturer shall establish and maintain an 
adequate organizational structure to ensure that devices are designed 
and produced in accordance with the requirements of this part.
    (1) Responsibility and authority. Each manufacturer shall establish 
the appropriate responsibility, authority, and interrelation of all 
personnel who manage, perform, and assess work affecting quality, and 
provide the independence and authority necessary to perform these tasks.
    (2) Resources. Each manufacturer shall provide adequate resources, 
including the assignment of trained personnel, for management, 
performance of work, and assessment activities, including internal 
quality audits, to meet the requirements of this part.
    (3) Management representative. Management with executive 
responsibility shall appoint, and document such appointment of, a member 
of management who, irrespective of other responsibilities, shall have 
established authority over and responsibility for:
    (i) Ensuring that quality system requirements are effectively 
established and effectively maintained in accordance with this part; and
    (ii) Reporting on the performance of the quality system to 
management with executive responsibility for review.
    (c) Management review. Management with executive responsibility 
shall review the suitability and effectiveness of the quality system at 
defined intervals and with sufficient frequency according to established 
procedures to ensure that the quality system satisfies the requirements 
of this part and the manufacturer's established quality policy and 
objectives. The dates and results of quality system reviews shall be 
documented.
    (d) Quality planning. Each manufacturer shall establish a quality 
plan which defines the quality practices, resources, and activities 
relevant to devices that are designed and manufactured. The manufacturer 
shall establish how the requirements for quality will be met.
    (e) Quality system procedures. Each manufacturer shall establish 
quality system procedures and instructions. An outline of the structure 
of the documentation used in the quality system shall be established 
where appropriate.