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A Device Master Record is a compilation of all the instructions, drawings and other records, that must be used to produce a product. The Device Master Record is often referred to as simply DMR. The term is used in Quality Management Systems that cover product design and production. The physical appearance of the DMR can be a binder with documents, a document that can refer to other documents, or the same concepts in a computer as documents in a database. One of the purposes of the Device Master Record, is to separate the production process from the design process. After a product design department is updating their design documents, the design has to be transferred to a production scenario. For instance, if the product incorporates software, the software must be compiled and tested before it is given to the production department. Similarly, if a piece of plastic is used in the product, a plastic mould must be created before production can start. Once everything is ready for switching to making the new design, the device master record is updated. All products, that are produced according to such quality management systems, can refer to a specific DMR that was used to produce it. The DMR will specify exactly what plastic moulds to use, what software builds to install etc. If an error is found in a product, the manufacturer may identify this problem to specific versions of the DMR, possibly using a CAPA, and may then choose to issue notices to customers for products, that have been built according to these versions of the DMR, or make a product recall. ==References== * (CFR - Code of Federal Regulations Title 21, Sec. 820.181 Device master record ) * (ISO 13485 sample procedures ), identifying ISO 13485 equivalent to DMR 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Device Master Record」の詳細全文を読む スポンサード リンク
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