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ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

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iso 13485 - medical device qms, iso 9001 - quality management systems, differences (general)
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  #1  
Old 12th September 2010, 01:14 PM
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Question ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Dear Coves

At work we are told by management that the quality systems will be changing in the near future. From ISO 13485 to a process based ISO 9000.

Can some one point out the pros and cons between the two ?

-QE

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  #2  
Old 12th September 2010, 02:50 PM
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

If you are under 13485 you already meet 9001

13485 is more stringent and specifically for medical device just as TS 16969 is for automotive and AS 9100 is for aerospace...basically all the same and you don't have to do anything special or different to conform to 9001, it's a done deal
Thanks to Randy for your informative Post and/or Attachment!
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  #3  
Old 12th September 2010, 03:45 PM
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Also see this oldie but goodie:

Differences - ISO 13485 - Requirements in Addition to ISO 9001
  #4  
Old 12th September 2010, 05:06 PM
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.

Last edited by Marc; 12th September 2010 at 08:16 PM. Reason: Add emphasis.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  #5  
Old 12th September 2010, 05:24 PM
DannyK

 
 
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

There are many more requirements for documented procedures with ISO 13485:2003. Since you are dealing with medical devices, there are expectations that your system will be more robust.
Regulatory requirements play a major role with ISO 13485:2003.

Last edited by Marc; 12th September 2010 at 08:11 PM. Reason: Hi-lited a significant point.
Thanks to DannyK for your informative Post and/or Attachment!
  #6  
Old 12th September 2010, 05:40 PM
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Thumbs up Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by Sidney Vianna View Post

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.
Thanks for that very salient, and often overlooked, point, Sidney!
  #7  
Old 12th September 2010, 08:15 PM
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by DannyK View Post

<snip> Regulatory requirements play a major role with ISO 13485 <snip>
Can you be more specific?
  #8  
Old 13th September 2010, 12:46 AM
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Re: ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

Quote:
In Reply to Parent Post by Marc View Post

Can you be more specific?
Just pitching in, while DannyK would write back ...
By your 13485 QMS if you are to respect
FDA requirement (your medical devices may be getting into USA) or
MDD / IVD requirements (your medical devices may be getting into EU) or
CMDR requirements (your medical devices may be geting into Canada) or
the respective regions regulatory requirements wherever your medical devices will be entering the market
These requirements becomes a part of your QMS activities, and they get to be mentioned in your QMS documentation, and addressed accordingly. These will be audited by you in internal audits and by the CB or NB etc etc.
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