The technical file is a collection of documents, hence the name "file".
The technical file is often confused, even by professionals, with the installation, use and maintenance manual, but they are two different things. In fact, within the technical file there must be the manual, which is one of the documents that make up the file, but the latter is much more.
We can state that the technical file is the CE marking in its documentary form, that is, it is the written "form" of the CE marking.
The CE marking is a set of activities that the manufacturer necessarily carries out in order to create a product. Risk analysis, drawings, diagrams, calculations, tests, checks on purchased materials, production checks, final testing are all activities that cannot be missing from a production cycle.
The producer, almost always interested in achieving the final objective, i.e. the creation of the product, often forgets to formalize, that is, put all these activities in black and white, with the consequence that he can achieve a product that complies with the laws, but is not able to prove it with documents.
The technical file consists of the following documents:
⦁ Installation, use and maintenance manual,
⦁ Declaration of conformity,
⦁ Label, containing the fundamental data of the product and the CE mark,
⦁ Standards respected for construction, performance, safety and quality
⦁ Risk analysis and compliance with the Regulations
⦁ Bill of materials of components and materials used,
⦁ List of suppliers,
⦁ Drawings, calculation reports, photos, any certificates or test tests
⦁ Production control procedures,
⦁ Testing procedure.
The manual, declaration of conformity and label documents must accompany any product on sale.