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Definition Actively Manufacturing - ISO 13485 Definition and clarification

J

jzengj

#1
Hi guys :bigwave:,

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! :D
 
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somashekar

Staff member
Super Moderator
#4
Jasmine...
Did you mean to say that you had no any production activities at all between the two CB audits... ?
 
C

chasf

#8
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.
 
J

jzengj

#9
chasf, somashekar,

thank you so much for the advice! Looks like this is best left to our CB to make a decision, and I will be contacting my CB to discuss further on this.
 
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