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Test quality control procedures for proper implementation.


CONTROL ID
06610
CONTROL TYPE
Testing
CLASSIFICATION
Detective

SUPPORTING AND SUPPORTED CONTROLS



This Control directly supports the implied Control(s):
  • Perform Quality Management on all newly developed or modified systems., CC ID: 01100

There are no implementation support Controls.


SELECTED AUTHORITY DOCUMENTS COMPLIED WITH



  • § 5.6.5: For software systems assigned to Class B and Class C software safety classes, the medical device manufacturers shall evaluate integration testing procedures to ensure they are correct. § 5.7.4: For software systems assigned to Class B and Class C software safety classes, the medical devic… (§ 5.6.5, § 5.7.4, ISO 62304 - 2006 Medical device software - Software life cycle processes, 2006)
  • determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements. (8.4.2 ¶ 2(d), ISO 9001 Quality Management systems - Requirements, Fifth edition 2015-09-15)
  • Implement new system design procedures, test procedures, and quality standards. (T0121, Reference Spreadsheet for the Workforce Framework for Cybersecurity (NICE Framework)”, July 7, 2020)