04 · Treat and evidence · Health

Design operation, evaluation and improvement

Controls must make safe use practical for staff under pressure and define when the system is paused, escalated or blocked.

HEALTH WORKING CONTEXT

Set clinical safety controls

The system operates around sensitive health information and may influence clinical or service decisions. Patient safety and clinical accountability are material.

Evidence bar

Clinical safety case approval
Staff training and escalation protocol
Pause and rollback criteria

REVIEW CHECKPOINTS

AIMS Operating Procedure

Require human review with authority to overrideDefine downtime, escalation and incident routesSet monitoring for safety, equity and over-relianceReuse compatible ISO processesSpecify documented informationInclude internal audit and management review

AIMS Operating Procedure

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Operating procedure

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Annex A control mapping

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Monitoring, internal audit and management review

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Nonconformity and continual improvement

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