Radio Equipment Directive Module H

Full quality assurance (FQA) is an approval of the manufacturer’s processes which permits the application of the Notified Body number to products within the scope of the full quality assurance.

The manufacturer submits an FQA application to a single Notified Body of their choice, which includes a sample set of technical documentation for each product type. The quality system must ensure compliance of the electronic equipment with the requirements of the RED. Also, the processes must ensure compliance of the products. The manufacturer needs to lodge an application for the assessment of his quality system with Telefication and must allow a Notified Body access to audit design, manufacture, inspection, test and storage areas and provide necessary information on the quality system records. Quality systems based upon ISO 9001 and test facilities operating to ISO17025 inherently meet many but not necessarily all of the requirements for FQA Approval under the RED.

In case of Module H (RED) audits on site, the existing quality management system of ISO-IEC-17021 of Kiwa Netherlands will be followed. Due to this approach, Kiwa Notified Body number “CE 0620” will be applicable and must be indicated on the related devices as soon the Module H (RED) audit on site is completed successfully.

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