- Govinfo.gov PDF - Title 21 - Part 820. Information and documentation can be found in our developer resources. Enhanced Content - Developer Tools. Editorial codification of the general and permanent rules published in the Federal Register.
- Correspondence Between ISO and 21 CFR 820 Regulatory Compliance Associates® Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158 5 ISO US FDA Quality System Regulation (QSR - 21 CFR 820) The quality manual shall outline the structure of the documentation used in the quality management system.
FDA QSR!21 CFR PART 820 ' ISO 1 Scope 2 Normative References. ISO-vsFDA-21-CRF-Part-820 (1).pdf Created Date: 4/15/2019 3:32:28 PM.
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The information on this page is current as of April 1 2020.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
| | [Code of Federal Regulations] | | [Title 21, Volume 8] | | [Revised as of April 1, 2020] | | [CITE: 21CFR820.50] |
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| CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| | SUBCHAPTER H - MEDICAL DEVICES |
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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 § 820.40. |
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21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
Fda 21 Cfr Part 820 Pdf
61 FR 52654, Oct. 7, 1996, unless otherwise noted.
Fda 21 Cfr Part 820 Pdf
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