New Product – Standard Compliance

Applicable in the case of a new product
(if a harmonized standard applies to the product)

Package contents

• Client notification
• Process documentation
• Schedule development
• Project implementation
• Discussion of the applicable standard
• Coordination of test points as defined by the standard
• Alignment with procedures applied by ÉMI Nonprofit Kft.
• Preparation of factory production control documentation in parallel with initial type testing
• Definition of processes at the production site
• One in-person consultation at the client’s site
• Finalization of the factory production control manual (after initial type testing is completed)
• Consultation with the client regarding the content of the applicable standard
• If no lab is available at the manufacturer: obtaining external lab quotations / if a lab is available: identification of required measuring equipment and calibration needs
• Determination of tests required under the “System 2+” scheme
• If requested by the client, arrangement of laboratory testing (subject to extra charge)
• Preparation of the declaration of performance in accordance with Annex III of EU Regulation 305/2011
• Conducting 1 internal audit
• Preparation of related documentation (in case of discrepancies, agreement on corrective actions and verification of implementation)
• Handover of the complete documentation to the client
• Verification of the existence of required template documents
• Client notification about the delivered documentation