CERTIFICATION & COMPLIANCE GUIDE

LVD assessment process: design evidence and production control

Connect the safety assessment to manufactured equipment instead of treating a prototype result as an annual certification audit.

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01

Plan the actual assessment activities

The LVD procedure is internal production control under Annex III. Establish the applicable safety objectives, product design, intended conditions and risk analysis, then determine the calculations, examinations and testing needed to demonstrate conformity. This is not automatically a management-system audit or an independent body’s approval visit.

A test plan must identify the specimen, configuration, methods and limits. Production controls must ensure that manufactured units remain consistent with the assessed file. Record critical component specifications, assembly controls and changes so that the evidence describes the equipment actually supplied, not an earlier prototype with a similar model name.

02

Hypothetical case: substituted thermal protection

A heater prototype was assessed with a specified thermal cut-out. Production later substitutes another part whose supplier provides its own datasheet and certificate. Compare operating characteristics, installation, wiring, fault protection and the tested build. The supplier document alone does not establish the substituted part’s effect on the finished heater.

Record the substitution as an open technical change. Obtain a justified equivalence assessment or the additional examinations/testing required for the changed design. Check which manufactured batches used the replacement and how release was controlled. A completed prototype report cannot close a production discrepancy without evidence linking the new configuration to the safety objectives.

03

Closure and decision records

Keep findings distinct: missing documentation, failed safety results, specimen differences and production-control gaps require different responses. Each open item should identify its evidence, responsible person and closure criterion. A revised drawing or component certificate is not proof that the physical build has been corrected and reassessed.

Kayra can coordinate the evidence review and action register. The manufacturer determines supported conformity and maintains production controls; the laboratory issues its own defined results. Close the relevant design and batch questions before declaration or release, preserving unresolved restrictions instead of converting a scheduled assessment into a guarantee.

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For “LVD assessment process: design evidence and production control”, share the current product model, rated voltages and available records. The agreed technical scope determines which further evidence is needed.

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