ISO 13485 and document control for programs

#1
I have been doing research on the web regarding ISO 13485 and document control and can't find a specific answer; could someone please help? The question is: Do programs (CNC programs, CMM programs, etc.) fall under the document control requirements? Any help you could give would be appreciated!
 
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William55401

Quite Involved in Discussions
#2
Welcome to the Cove. I would suggest you look at 4.1.6 as related to QMS relevant software. This section links to 4.2.5 records. Yes, these objects (executable files) would need to be controlled.

One more. This is manufacturing, inspection, and test related software. Most orgs develop a non product software process to address this space.

Hope this helps. Good luck!
 
#3
Thanks for the warm welcome! Right, so 4.1.6 is about software validation but I was thinking more like document control. If an auditor asked me tomorrow to show evidence that a CNC program had been approved, I would not be able to do so.
 

yodon

Staff member
Super Moderator
#5
Just to expand on the response from @William55401 ...

Your programs need to be under configuration / change control. (You need assurance that what you validated is unchanged.)

Associated documents (requirements validation protocols, validation records, validation report, etc.) would go under document (and record) control. Your validation report would conclude (presumably) that version x of your program was approved for use.
 

Gisly

Starting to get Involved
#6
No software is an island. Suggest to look into the IEC 80002-2 for your software validation and especially on the principles of downstream measures when evaluating the risks asscociated with your software. If downstream QC control of parts/material that have been processed by your CNC etc. gives high/full test coverage you may ease on the controls enforced on your software.

The IEC 80002-2 also gives you a toolbox for controls that may choose to use. We integrated a table with the toolbox-items in our SW Validation template as a checklist for the evaluation.
 
#7
Yes, you need both. Approval and validation.
No software is an island. Suggest to look into the IEC 80002-2 for your software validation and especially on the principles of downstream measures when evaluating the risks asscociated with your software. If downstream QC control of parts/material that have been processed by your CNC etc. gives high/full test coverage you may ease on the controls enforced on your software.

The IEC 80002-2 also gives you a toolbox for controls that may choose to use. We integrated a table with the toolbox-items in our SW Validation template as a checklist for the evaluation.
Good to know! Thanks to all who have commented. Perhaps this may help another too.
 
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