[Title 21 CFR E]
[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 E - Purchasing Controls]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falsePurchasing ControlsESubpart EFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATION
                     Subpart E--Purchasing Controls



Sec. 820.50  Purchasing controls.

    Each manufacturer shall establish and maintain procedures to ensure 
that all purchased or otherwise received product and services conform to 
specified requirements.
    (a) Evaluation of suppliers, contractors, and consultants. Each 
manufacturer shall establish and maintain the requirements, including 
quality requirements, that must be met by suppliers, contractors, and 
consultants. Each manufacturer shall:
    (1) Evaluate and select potential suppliers, contractors, and 
consultants on the basis of their ability to meet specified 
requirements, including quality requirements. The evaluation shall be 
documented.
    (2) Define the type and extent of control to be exercised over the 
product, services, suppliers, contractors, and consultants, based on the 
evaluation results.
    (3) Establish and maintain records of acceptable suppliers, 
contractors, and consultants.
    (b) Purchasing data. Each manufacturer shall establish and maintain 
data that clearly describe or reference the specified requirements, 
including quality requirements, for purchased or otherwise received 
product and services. Purchasing documents shall include, where 
possible, an agreement that the suppliers, contractors, and consultants 
agree to notify the manufacturer of changes in the product or service so 
that manufacturers may determine whether the changes may affect the 
quality of a finished device. Purchasing data shall be approved in 
accordance with Sec. 820.40.