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Actively Manufacturing - ISO 13485 Definition and clarification
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Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
Actively Manufacturing - ISO 13485 Definition and clarification
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  Post Number #1  
Old 2nd March 2015, 04:54 AM
jzengj

 
 
Total Posts: 11
Please Help! Actively Manufacturing - ISO 13485 Definition and clarification

Hi guys ,

I'm confused by what seems like a basic issue..and would like to clarify with all you knowledgeable people out there, hope you may pardon my noobness...

My organization has been re-certified to ISO 13485 last May, and our surveillance audit is coming up soon. We're certified for the production scope - we run production for a short while (over a span of 2months), and move on to the next one. I would like to know if there is a need for us to have at least one new production project between our last audit and upcoming one to have something for the auditors to see.

Reason why i'm asking this is because of this statement on the ISO 13485 wiki page, which states that " an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration."

Appreciate your kind help in advance!

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  Post Number #2  
Old 2nd March 2015, 01:53 PM
J0anne

 
 
Total Posts: 439
Re: Actively Manufacturing - ISO 13485 Definition and clarification

There is no requirement for the number of production projects.
Thanks to J0anne for your informative Post and/or Attachment!
  Post Number #3  
Old 3rd March 2015, 03:10 AM
jzengj

 
 
Total Posts: 11
Re: Actively Manufacturing - ISO 13485 Definition and clarification

Hi Joanne,
I see, thank you for enlightening me!
  Post Number #4  
Old 3rd March 2015, 03:57 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,344
Re: Actively Manufacturing - ISO 13485 Definition and clarification

Jasmine...
Did you mean to say that you had no any production activities at all between the two CB audits... ?
  Post Number #5  
Old 3rd March 2015, 04:39 AM
jzengj

 
 
Total Posts: 11
Re: Actively Manufacturing - ISO 13485 Definition and clarification

Hi somashekar,
Yup, that's what i'm trying to say...
  Post Number #6  
Old 3rd March 2015, 04:55 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,344
Re: Actively Manufacturing - ISO 13485 Definition and clarification

Quote:
In Reply to Parent Post by jzengj View Post

Hi somashekar,
Yup, that's what i'm trying to say...
As production or no production is a business decision, that is market driven., please discuss this situation with your CB at an early date.
  Post Number #7  
Old 3rd March 2015, 11:09 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,344
Re: Actively Manufacturing - ISO 13485 Definition and clarification

Can anyone from the CB domain give a better response to Jasmine ..... Thanks
  Post Number #8  
Old 3rd March 2015, 11:53 AM
chasf

 
 
Total Posts: 77
Re: Actively Manufacturing - ISO 13485 Definition and clarification

The auditor should be willing to take your unique situation into consideration. The only issue that may arise is the auditor may have been planning on auditing the production process.
Perhaps you could contact the auditor so that adjustments could be made the the audit schedule leaving out the affected areas.
If possible maybe you could schedule the next audit during a time of production.
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