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RM-007HighProviderPreventive

Residual Risk Documentation and Disclosure

Providers must document residual risks that users need to be informed of and include relevant information in the system instructions for use, enabling deployers to manage remaining risks appropriately.

Articles:Article 9(2)(d)Article 13(1)

Evidence Examples

  • Residual risk statement in IFU
  • Residual risk register
  • User notification documentation

Standards

ISO 42001:2023 §6.1.3

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Residual Risk Documentation and Disclosure (RM-007) | AZComply Controls