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Establish, implement, and maintain poor quality material removal procedures.


CONTROL ID
06214
CONTROL TYPE
Establish/Maintain Documentation
CLASSIFICATION
Preventive

SUPPORTING AND SUPPORTED CONTROLS



This Control directly supports the implied Control(s):
  • Establish, implement, and maintain system testing procedures., CC ID: 11744

There are no implementation support Controls.


SELECTED AUTHORITY DOCUMENTS COMPLIED WITH



  • The organization shall establish and document special arrangements for controlling contaminated or potentially contaminated products in order to prevent other products, the work environment, or personnel from being contaminated. (§ 6.4(d), ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes, 2003)
  • A medical device manufacturer shall establish and maintain procedures for using and removing manufacturing material that could have an adverse effect on product quality to ensure it is removed or limited to an amount that will not affect the quality of the device. The removal or reduction of the mat… (§ 820.70(h), 21 CFR Part 820, Subchapter H - Medical Devices, Part 820 Quality System Regulation)