teklif al

Module D Certification Service (conformity to type based on quality assurance of the production process)

The Personal Protective Equipment products falling into category III according to EU 2016/425 regulation shall be monitored by a Notified Body for the homogeneity of the manufacturing of the PPE to the EU Type Examination certification based on either Annex VII (Module C2) or Annex VIII (Module D) of the regulation. The application for Module D (Annex VIII) will be evaluated with the application of the manufacturer. The application for certification shall be annexed with all necessary technical and official documentation by the manufacturer also the valid EU Type Examination Certificate and its technical annexes in case the EU Type Examination Certificate is not issued by Universal Certification.

Universal Certification will review the application and technical documentation provided by the manufacturer and will send a proposal for Module D certification with the service fee and monitoring method for homogeneity of the PPE in case Universal Certification have necessary resources for the manufacturer.

Universal Certification Module D service for monitoring the product homogeneity will be based on conducting a yearly onsite audit for the effectiveness of the full quality assurance system implemented by the manufacturer. This audit will focus on the evidences of successful implementation of the full quality assurance system of the manufacturer.

Universal Certification may also take some samples for testing the performance of the PPE to support the output of the onsite audits. The sampling of the PPE and repeating some of the performance tests may also be carried out depending on the quantity of manufactured PPE, complaints received from the market and information from the market surveillance authorities.

Universal Certification will suspend or withdraw the Module D contract and certificates upon insufficient cooperation of the manufacturer on Module D monitoring activities or insufficient corrective actions taken by the manufacturers.

You can download the application form for Module D Certification Application Form here

 

The technical documentation shall be annexed to the application is explained in the Annex III of the EU 2016/425 regulation. The EU Type Examination Certificate and annexes shall be annexed to the application form if not issued by Universal Certification. For more information please review Annex VIII of the EU 2016/425 regulation.

GERİ

Please register to our newsletter for news and announcements from us, first to be notified.