[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.