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Device History Record (DHR) Templates or Examples Wanted


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design history record (dhr), forms and templates (general), iso 13485 - medical device qms
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  Post Number #1  
Old 7th March 2005, 05:20 PM
stef2004

 
 
Total Posts: 2
Hehehe... Device History Record (DHR) Templates or Examples Wanted

Hi!

I am presently building our company's documentation structure, in the process of preparing for our ISO:13485 certification. Is there anywhere I can find templates for a DHR?

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  Post Number #2  
Old 7th March 2005, 11:05 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,542
Quote:
In Reply to Parent Post by stef2004

Hi!

I am presently building our company's documentation structure, in the process of preparing for our ISO:13485 certification. Is there anywhere I can find templates for a DHR?
FYI, there is no such thing as a DHR template. Simply because, it is unique to your device and system. It's the collection of documents and records of the fabrication, assembly, processing, inspection and testing of the device.

Last edited by Al Rosen; 7th March 2005 at 11:12 PM.
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  Post Number #3  
Old 7th March 2005, 11:37 PM
stef2004

 
 
Total Posts: 2
Quote:
In Reply to Parent Post by Al Rosen

FYI, there is no such thing as a DHR template. Simply because, it is unique to your device and system. It's the collection of documents and records of the fabrication, assembly, processing, inspection and testing of the device.
Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health Canada lists the following:

proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity manufactured
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the DMR.

Would that list cover everything, or just about?

Thanks
Thanks to stef2004 for your informative Post and/or Attachment!
  Post Number #4  
Old 8th March 2005, 01:28 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,542
Quote:
In Reply to Parent Post by stef2004

Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health Canada lists the following:

proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity manufactured
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the DMR.

Would that list cover everything, or just about?
Thanks
That covers it.
  Post Number #5  
Old 23rd March 2005, 05:49 PM
pbojsen's Avatar
pbojsen

 
 
Total Posts: 55
DMR and DHR

The Device Master Record should list all of the documents and procedures used to make the product.

The Device History Record is usually a folder that contains (at least in our medical device plant):

* either a copy of the documents the product was made to or a traveler that lists the documents, revisions, and dates of manufacture.

* quality assurance documentation, such as label reports with an actual label on the report

* a form filled out by QA as final inspection of product, and one for final inspection of folder

* BOM product was made to, etc.

The list is not all-inclusive, but you get the idea. Documents in the DHR map back to the requirements of the DMR. Does that help?

Last edited by pbojsen; 23rd March 2005 at 05:51 PM.
Thanks to pbojsen for your informative Post and/or Attachment!
  Post Number #6  
Old 9th October 2013, 03:18 PM
deidrajohnson40

 
 
Total Posts: 1
Re: Wanted: Device History Record (DHR) Templates

Quote:
In Reply to Parent Post by Al Rosen View Post

That covers it.
Hi Al,
I was wondering if you had an DHR procedure template I can use. I understand what required to go into the DHR and I understand about all of the forms used on the manufacturing floor for a finish device product, but the actually procedural process written into a SOP or DHR procedure. Are you able to help me. I am writing a DHR procedure for a medical device company. Deidra
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