CE Marking and Technical File Preparation training builds the CE process step by step so you can place your product on the EU market: identifying the applicable directives or regulations, choosing the conformity assessment route, and preparing the technical file and the declaration of conformity (DoC). A certificate of attendance is issued to participants.
CE Marking training covers, as a whole, the process of placing a product legally on the EU/EEA market bearing the CE mark. The training covers the meaning and scope of the CE mark, identifying the EU directives or regulations applicable to the product (for example Machinery, Low Voltage, EMC, Pressure Equipment, Medical Devices, Construction Products), the use of harmonized standards, determining the conformity assessment modules and whether the involvement of a notified body is required, risk analysis, the content and preparation of the technical file, drawing up the EU declaration of conformity (DoC), affixing the CE mark correctly, and the obligations of manufacturers, importers and distributors. The training is reinforced in a practical way through directive identification and technical file construction on sample products.
The training suits product development and R&D, quality, compliance and foreign trade or export teams, manufacturers, importers and the relevant employees of organizations that want to place CE regulated products on the EU market; there is no prerequisite. A certificate of attendance or achievement is issued at the end of the training. An important point of framing: for most CE marking, conformity rests on the manufacturer's own declaration; however, for high risk products a notified body takes part. The training teaches the process and the preparation of the technical file; the certification and notified body process is carried out separately. Sistem Patent Kalite both delivers the training and can provide consulting for CE certification and the technical file process (see our CE Certificate page).
Note: Training is delivered by Sistem Patent Kalite (Academy); participants receive a certificate of attendance or achievement. Training alone does not grant the related ISO certificate; certification is issued after the audit of an accredited certification body, and the training prepares you for that process. Internationally recognized qualifications such as Lead Auditor depend on the course being accredited or approved (for example by Exemplar Global or IRCA). Duration and scope are set according to your needs ().
For most products the CE mark is not 'issued' by an authority; the manufacturer carries out the conformity assessment, prepares the technical file and the declaration of conformity (DoC), and affixes the CE mark itself. For high risk products a notified body takes part in the process. The training teaches this distinction.
The technical file is the set of documents proving that the product conforms to the applicable requirements (design, risk analysis, test reports, list of standards, information for use and similar). The training covers the content of the technical file and how to prepare it in a practical way.
More than one directive or regulation may apply to a product; identifying the correct ones is the most critical step of the CE process. The training teaches how to determine the applicable directives and harmonized standards according to the characteristics of the product.
Yes, a certificate of attendance or achievement is issued to participants. This is not the product's CE certificate or conformity; CE conformity is achieved through a product specific process (and with a notified body where required).
We will design the course around your team; you can also assign courses through the corporate training software (LMS) and track completion and certificates of attendance from a single platform.