Glossary Term: Design history file (DHF)

A Design History File or DHF is the collection of records documenting all stages of the design phase. The DHF shows the development process through the collection of drafts, detailing decision making, meeting notes, test data and reports that lead to the production and manufacturing of the final product. The DHF should layout the drafting process in chronological order for ease of understanding and clarity. As part of the regulatory process and good manufacturing practices, a DHF may be required for a certification mark, as the DHF will show the product has been scrutinized and rigorously tested to meet quality control standards.

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