Clause 6.5.3: Requirements activities in validation
The requirements work in validation identifies the validation scope and the corresponding validation actions.
What clause 6.5.3 asks
The requirements work in validation identifies the validation scope and the corresponding validation actions. The scope includes the characteristics of the system, element or artefact under validation and the results expected. The operational concept and the containing system's baselined stakeholder requirements are part of that scope. The results are traced, and the traceability of the validated elements is maintained in a requirements traceability matrix or a similar information item.
Why it matters
Validation asks whether the system is the right one, not whether it was built to the specification. The clause ties the scope to the operational concept and the stakeholder baseline, which prevents a validation that only repeats the verification tests. The traceability of the validated elements is what shows the result applies to the delivered configuration.
No clause level change is public for this unit; the DIS keeps the title and scope, and the requirement text is not released.
What good looks like
Write the validation scope before the design freeze and agree it with the operational owner. Name the characteristics, the environment, the participants and the expected result. Link each validated element to the delivered configuration so the result cannot be read against the wrong build.
Evidence an assessor asks for
The assessor will ask who validated the system in its intended environment and against which stakeholder baseline. A validation run by the development team alone is a weak answer.
- Validation plan The scope, the characteristics to be validated, the expected results and the actions
- Operational concept link The concept and stakeholder requirements that define the intended use
- Validation results The evidence, the participants and the outcome for each action
- Traceability The link from the validated element to the delivered configuration
Where it commonly fails
- Validation repeats the verification tests and calls the result user acceptance
- The operational concept used for validation is the design document, not the stakeholder concept
- The validated configuration is not the delivered configuration
What to do before the revision
Write the validation scope before the design is frozen. It forces the operational owner into the project while there is still time to change the requirement.
Read across
- 5.2.3 Transformation of needs into requirements
- 6.3.3.7 Manage stakeholder needs and requirements
- 6.5.2 Requirements activities in verification
- 6.6.2.3.3 Perform information management
← 6.5.2 Requirements activities in verification 6.6.1 Management overview →
Source for clause 6.5.3: ISO/IEC/IEEE 29148:2018, Clause 6.5.3, retrieved 19 October 2026. The revision note rests on ISO page 94091. The requirement, evidence and gaps are written from our record. Every source.