[Title 21 CFR B]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 820 - QUALITY SYSTEM REGULATION]
[Subpart B - Quality System Requirements]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseBSubpart BFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATION
                 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

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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.



Sec. 820.22  Quality audit.

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



Sec. 820.25  Personnel.

    (a) General. Each manufacturer shall have sufficient personnel with 
the necessary education, background, training, and experience to assure 
that all activities required by this part are correctly performed.
    (b) Training. Each manufacturer shall establish procedures for 
identifying training needs and ensure that all personnel are trained to 
adequately perform their assigned responsibilities. Training shall be 
documented.
    (1) As part of their training, personnel shall be made aware of 
device defects which may occur from the improper performance of their 
specific jobs.
    (2) Personnel who perform verification and validation activities 
shall be made aware of defects and errors that may be encountered as 
part of their job functions.