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en iso 13485:2012, iso 13485 - medical device qms, mdd (medical device directive)
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  #1  
Old 16th March 2012, 06:44 AM
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Question EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Now that EN ISO 13485:2012 has been published (in my case BS EN ISO 13485:2012) and the fact that ISO 13485 is current, is this going to cause some confusion? This could especially be the case on certificates, as I've seen examples out there in the ether which indicate EN ISO 13485:2003, which would no no longer be valid (after 31st August 2012 when it kicks in). In our case we have a ISO 13485:2003 certificate - so no need to change.

Just for information the new EN version now has links to the EU Medical Directives Directives.

Any thoughts?

Steve

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Old 16th March 2012, 10:27 AM
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Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Just checked our certificates and they also refer just to ISO 13485:2003 so those should be OK.

But each of our Tech files has a list of harmonised standards to which we are claiming compliance, including 13485. So once it is published in the OJ I guess they will all have to be updated.
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  #3  
Old 16th March 2012, 10:43 AM
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Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Quote:
In our case we have a ISO 13485:2003 certificate - so no need to change.
Are you sure?

Are you using the harmonized standards to gain presumption of conformity?

The harmonized standard is the EN one, so any presumption of conformity can only be given to the EN version, not the ISO version.

IF you are using EN ISO 13485 to gain presumption of conformity, when the harmonized standards change, the older one do not give a presumption of conformity anymore.

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  #4  
Old 16th March 2012, 10:58 AM
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Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Quote:
In Reply to Parent Post by SteveK View Post

Now that EN ISO 13485:2012 has been published (in my case BS EN ISO 13485:2012) and the fact that ISO 13485 is current, is this going to cause some confusion? This could especially be the case on certificates, as I've seen examples out there in the ether which indicate EN ISO 13485:2003, which would no no longer be valid (after 31st August 2012 when it kicks in). In our case we have a ISO 13485:2003 certificate - so no need to change.

Just for information the new EN version now has links to the EU Medical Directives Directives.

Any thoughts?

Steve
May be from Aug 2012, the CB's will issue the ISO13485:2003 + EN ISO13485:2012 as two separate certificates on request from customers that they need this to align with the EU harmonized standards.... Similar to the CMDCAS ISO13485.
Is there any listing in the EU as to who are the recognized registrars who can certify to EN ISO13485:2012 ?

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Last edited by somashekar; 16th March 2012 at 11:22 AM.
  #5  
Old 16th March 2012, 11:22 AM
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Lurker Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

Are you sure?

Are you using the harmonized standards to gain presumption of conformity?

The harmonized standard is the EN one, so any presumption of conformity can only be given to the EN version, not the ISO version.

IF you are using EN ISO 13485 to gain presumption of conformity, when the harmonized standards change, the older one do not give a presumption of conformity anymore.
Well maybe I'm not so sure!

We get our standards from BSI and within their listing of the standards they have:

"International Relationships BS EN ISO 13485:2012 Identical, ISO 13485:2003 Identical"

It is the NB who issued the certificate which indicates compliance to just "ISO 13485:2003", so maybe I should be making inquiries with them since I am complying with Annex II of the MDD 93/42/EEC full QMS, based on the (most) current harmonised standard. However the actual title of the BS EN ISO 13485:2012 harmonised standard is:

"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)".

Maybe Somashekar is right in what he indicates.

But still really confused.

Steve
  #6  
Old 16th March 2012, 11:30 AM
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Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Quote:
We get our standards from BSI and within their listing of the standards they have:

"International Relationships BS EN ISO 13485:2012 Identical, ISO 13485:2003 Identical"

It is the NB who issued the certificate which indicates compliance to just "ISO 13485:2003", so maybe I should be making inquiries with them since I am complying with Annex II of the MDD 93/42/EEC full QMS, based on the (most) current harmonised standard. However the actual title of the BS EN ISO 13485:2012 harmonised standard is:

"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)".
The technical part is the same, however, the annexes related to the medical devices directives are not.

My experience is that NBs and manufacturers work on somewhat of an "automatic" scheme based on certification to standards, but if we get in to the detail, some problems may arise (that's why I'm giving this warning).

As I said before, for the EU the only standards which give presumption of conformity are the harmonized ones, in this case, EN ISO 13485. The fact that it's technically equal to ISO 1385 helps, however, formally, an ISO 13485 certificate would not give you a presumption of conformity. This case of the EN 2012 version with only annexes changes might show this problem.

My advise would be - verify with your NB (and, in doing this, ask them them about the ISO certificate and presumption of conformity, just to make sure :-).

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Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  #7  
Old 16th March 2012, 11:43 AM
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Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

Quote:
May be from Aug 2012, the CB's will issue the ISO13485:2003 + EN ISO13485:2012 as two separate certificates on request from customers that they need this to align with the EU harmonized standards.... Similar to the CMDCAS ISO13485.
Is there any listing in the EU as to who are the recognized registrars who can certify to EN ISO13485:2012 ?
One of the main problems with this is : a 13485 certificate is NOT required to show compliance with the MDD. What is required is to show conformity with the essential requirements.

For EN ISO 13485:2012 (which corrects some of the linking problems with the presumption of conformity in older version), if you look into the annexes you will verify that only some clauses give presumption of conformity with some parts of the MDD.

What an NB would need to do is:

1 - ask the manufacturer if they are using a standard to gain presumption of conformity
2 - if so, they need to addres which standard it is (and if it's not an harmonized one, the standard cannot give presumption of conformity)
2 - for the harmonized standard, verify, in the annexes, which clause gives presumption of conformity with any essential requirement (or, in the case of EN 13485, to which part of Annex 2 the clauses give presumption of conformity)
3 - for those, verify that the manufacturer is is conformance with the clause of the standard
4 - verify if there are any other requirements of the directive which needs another round of verification (for example, directive requirements which are not covered by the clauses evaluated)


Or something like that.

However, to simplify stuff (and get more money :-)) NBs, usually sells the idea that an EN ISO 13485 certificate is required. Nothing against that, and it's great from the point of view that you can maybe use the certificate on other regulatory systems, but again, formaly, only a certificate to EN ISO 13485 give a presumption of conformity.

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Last edited by Marcelo Antunes; 16th March 2012 at 01:40 PM.
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Old 12th July 2012, 11:29 AM
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I Say... Re: EN ISO 13485:2012 vs. ISO 13485:2003 - Confusion?

I came across a publication that explains the changes.

It can be found at: www.ds.dk/en/

EDIT NOTE: The name of the document uploaded here was: ISO-13485_2012.pdf - See the next post in this thread for more information.

Last edited by Marc; 12th July 2012 at 12:23 PM. Reason: Edited to address a potential Copyright issue.
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