Sectors / 04

Assurance for software whose output informs care, operations, access, or safety-relevant decisions.

Independent software assuranceSM / 04.26

SecondMark position

The evidence model must account for intended use, human interpretation, data quality, operational context, and the consequences of omission as well as incorrect output.

The examination is bounded to defined claims, a versioned system, and evidence that can be traced to the state under review. Any material exclusion or uncertainty remains visible in the conclusion.

01

Core questions

What the examination needs to establish.

  1. 01

    Who acts on the system's output?

  2. 02

    What uncertainty is visible to users?

  3. 03

    How do data limitations alter behavior?

  4. 04

    Can failure be detected before harm compounds?

02

Evidence model

Evidence is assembled around the claim—not the folder structure.

01

Domain-specific operating context

Collected, attributed, challenged, and connected to the exact system boundary under examination.

02

Authority and consequence mapping

Collected, attributed, challenged, and connected to the exact system boundary under examination.

03

Human and automated control points

Collected, attributed, challenged, and connected to the exact system boundary under examination.

04

Failure containment and recovery evidence

Collected, attributed, challenged, and connected to the exact system boundary under examination.

Intended outcome

A bounded technical assurance view designed to inform governance without substituting for clinical or regulatory judgment.

Sector-aware assurance scopeMaterial risk and control analysisDecision-ready independent opinion
03

Professional boundary

What an opinion does—and does not—mean.

It provides

A traceable independent conclusion on defined claims, grounded in the evidence and system state examined.

It does not provide

A guarantee that failure is impossible, a permanent certification, or a conclusion beyond the stated scope and validity conditions.