Technical file

A technical file is a set of documents that describes a product, and can prove that the product was designed and according to the requirements of a quality management system.

All products that have a CE mark must have a technical file, which must contain the information that proves, that the product conforms to the EU directives for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do usually not have access to the technical file.

A technical file is usually based on a document archive system that ensure longevity of documents, and can either be based on paper or electronic files. One document may be named "Technical file", which lists all other documents that are considered part of the technical file.

A technical file will include drawings, specifications, reports, review records, meeting minutes, instructions, software source code etc.

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