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Establish, implement, and maintain system cleanliness requirements.


CONTROL ID
06614
CONTROL TYPE
Establish/Maintain Documentation
CLASSIFICATION
Preventive

SUPPORTING AND SUPPORTED CONTROLS



This Control directly supports the implied Control(s):
  • Establish, implement, and maintain work environment requirements., CC ID: 06613

There are no implementation support Controls.


SELECTED AUTHORITY DOCUMENTS COMPLIED WITH



  • § 7.5.1.2.1: The organization shall establish product cleanliness requirements if the organization cleans the product before its use and/or sterilization; if the product is supplied as non-sterile and the organization uses a cleaning process before it is sterilized and/or used; if the product is su… (§ 7.5.1.2.1, § 7.5.2.2, ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes, 2003)