Not every conformity pathway requires a factory review or audit. Depending on the technical regulation and the pathway applicable to the product, some cases may include elements related to production controls or the manufacturing facility, while these elements do not apply to other cases.
When Might the Factory Fall Within the Scope of Review?
Some regulations or conformity assessment pathways may include requirements related to production controls, factory data, or the manufacturing facility, alongside the review of the product and its documents. This does not apply to all products or all pathways; the requirements specific to the product and the case itself must be reviewed before determining whether this aspect is required.
Why Is There No Standardized Procedure for This Aspect?
The form of the factory-related review, if any, differs depending on the technical regulation, the conformity assessment pathway, and the requirements applicable to the case. The review may be document-based in some cases, while other cases may require additional assessment by the competent body. For this reason, it is not correct to assume that a factory review is or is not required before reviewing the product’s situation and pathway.
How Does SaberVerify Help Determine This Aspect?
We review the product’s situation, the expected pathway, and the relevant requirements to determine whether there are elements related to the factory or production controls that need to be completed or further assessed, and coordinate when needed with the conformity assessment body or the entity responsible for the case.
SaberVerify is an independent platform; it is not a government entity, not a conformity assessment body, and not an accreditation body. Requirements for factory review or production controls, when applicable, are determined according to the regulation, the conformity pathway, and the entity responsible for the case.
To find out whether your product’s pathway includes this aspect, you can fill out the product requirements check form, or contact us directly.