To maintain control over document and data changes. Iso 485 operational procedure qop4201 a control of documents 1. Protecting proprietary information medical device master. Upon compilation of all documents to be included in the master record, a device master record index template should be prepared to identify all items in the record and locations of these records. White paper device master records and medical device files. A device master record is a compilation of all the instructions, drawings and other records, that must be used to produce a product. General records, device master records, device history. Operational procedure qop4202, device master record.
The dmr for each type of device shall include, or refer to the location of, the following information. Documents that define the device, manufacturing process, and quality assurance specifications are organized into a file andor are referenced in an index called a device master record dmr. Much like the dhf is the history of the design, the dhr is the history of the device. Qms operational procedure qop4202 quality coach yumpu. The file contains 3 pages and is free to view, download or print. Each manufacturer shall maintain device master records dmrs. The official controlled copy of this manual is the digitally signed pdf document on the connect network server and visible to all. Records are maintained to demonstrate conformance to specified. Eng1042 device master record index includes descriptions such as product specification and product literature. Document stating results achieved or providing evidence of activities performed. Device master record operational procedure qop42 02 rev.
The list is controlled in accordance with operational procedure qop4202. The device master record should be accurate and complete because the essence of the qs regulation is a quality system based on designing a device to meet user needs, documenting the design and production procedures in the device master record and then producing a finished device that meets the device master record requirements. Qms operational procedure qop device master record issued by. Each manufacturer shall ensure that each dmr is prepared and approved in accordance with 820. The device history record demonstrates that a particular unitbatchlot was made according to the recipe. Records are important device master record, device history record. The qop42 02 device master record, effective date october 29, 2010, revision f, states in section 1. Describe requirements and intent for document controls. The total finished design output consists of the device, its packaging and labeling, and the device master record.
The dmr for each type of device shall include, or refer to the. After you remove a procedure from the system make sure to coordinate pertinant references in the quality manual and in other operational procedures. Fda medical device inspections fda small business regulatory education for industry redi. Device master record dmr is the term used in the quality system qs regulation for all of the routine documentation required to manufacture devices that will consistently meet company requirements. The advantage is that all documents are being kept together and thus are easy to manage.
Design history file dhf, device master record dmr, device. A quality manual that contains information including documents, records and other related. Operational procedure qop 4201, control of documents. Numbers into the manufacturing system database establishment and maintenance of the device master record establishment and maintenance of the technical file maintenance of quality records design history file 21 cfr part 820 quality system regulation iso medical devices quality management. Operational procedure qop42 02, device master record, defines how dmrs are established and maintained.
Documents included in dmr for each type or model of medical device the dmr includes the following types of documents. Iso 485 operational procedure qop4201 a control of. List pertinent sections of the quality manual and the operational procedures. The dmr for each device type shall include or refer to the. This list is based on 21 cfr part, device master record, but it also fully applies to iso edit this list carefully to delete any items that are not applicable installation or sterilization, for example. While these three acronyms can see confusing and easily interchangeable when you first hear them, if you look at the actual terms, theyre surprisingly descriptive.
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