Technical file - Technical documentation.
Technical documentation refers to all documents that describe, explain, or instruct on the use, maintenance, and development of a product or system. These include user manuals, installation instructions, maintenance instructions, and other technical documents. Technical documentation is a key part of the life cycle of any product, as it provides users with the information they need to use the product correctly.
A technical file is a collection of all documentation confirming the correctness of the CE marking procedure and the existence of official confirmation. Thus, everything related to product safety, the legal obligations with which it must comply, and all documentation provided by the manufacturer becomes part of the technical file.
Technical documentation is necessary, first and foremost, to ensure product safety, and then to comply with legislation.
The technical file is not just a set of documents that need to be created and then stored in a box or computer folder; this fundamental set of documents must be constantly updated, keep pace with the evolution of the products to which it relates, and be managed in such a way that it is reviewed at least once a year. In the event of a change in a standard or legislation, it is updated more frequently. Any changes or updates must be made to the technical documentation.
At the end of the activities carried out, even if it is simply a confirmation that nothing has changed, a report must be drawn up, which must be kept in the archive and which reflects the status of the documentation.
To carry out this activity, it is necessary to have knowledge of current legislation and the requirements for the preparation of official documentation.
Technical documentation (technical file) is an integral part of any production, as it is a system for collecting and exchanging important information at all stages of the project and production.
Properly compiled technical documentation ensures that all parties, including regulatory authorities, receive consistent and accurate information. This is especially important when it comes to user safety, where clear instructions and information are needed for decision-making, allowing any potential risks to be quickly identified and eliminated.
A properly compiled technical file reduces misunderstandings and improves communication between stakeholders. This leads to faster and more effective resolution of product-related issues.
The contents of the technical file are specified in the specific Directive or Regulation to which the product is subject, and each manufacturer is required to familiarise themselves with these requirements.