Scribd
Upload
26 views3 pages

Arabic Translate of Fda 21 CFR Part 820

Uploaded by

aboshok
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
26 views3 pages

Arabic Translate of Fda 21 CFR Part 820

Uploaded by

aboshok
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

fda 21 cfr part 820

fda 21 cfr part 820

TITLE 21--FOOD AND DRUGS


CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 820 QUALITY SYSTEM REGULATION
Subpart A - General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B - Quality System Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C - Design Controls
§ 820.30 - Design controls.
Subpart D - Document Controls
§ 820.40 - Document controls.
Subpart E - Purchasing Controls
§ 820.50 - Purchasing controls.
Subpart F - Identification and Traceability
§ 820.60 - Identification.
§ 820.65 - Traceability.
Subpart G - Production and Process Controls
§ 820.70 - Production and process controls.
§ 820.72 - Inspection, measuring, and test equipment.
§ 820.75 - Process validation.
Subpart H - Acceptance Activities
§ 820.80 - Receiving, in-process, and finished device acceptance.
§ 820.86 - Acceptance status.
Subpart I - Nonconforming Product
§ 820.90 - Nonconforming product.
Subpart J - Corrective and Preventive Action
§ 820.100 - Corrective and preventive action.
Subpart K - Labeling and Packaging Control
§ 820.120 - Device labeling.
§ 820.130 - Device packaging.
Subpart L - Handling, Storage, Distribution, and Installation
§ 820.140 - Handling.
§ 820.150 - Storage.
§ 820.160 - Distribution.
§ 820.170 - Installation.
Subpart M - Records
§ 820.180 - General requirements.
§ 820.181 - Device master record.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
Subpart N - Servicing
§ 820.200 - Servicing.
Subpart O - Statistical Techniques
§ 820.250 - Statistical techniques.
fda 21 cfr part 820
fda 21 cfr part 820

[Code of Federal Regulations]


[Title 21, Volume 8]
[CITE: 21CFR820.50]

TITLE 21--FOOD AND DRUGS


CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 820 -- QUALITY 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 § 820.40.

You might also like