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ISO 13485:2015 Pre-Release News and Discussion - Page 5


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iso 13485 - medical device qms, revisions to a document or standard, iso 13485:2016
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  Post Number #33  
Old 21st March 2012, 06:10 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,964
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

And, being on that... WG 1 is going to meet next week in London to continue the work in the revision of ISO 13485.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #34  
Old 22nd March 2012, 07:12 AM
Harigovindan

 
 
Total Posts: 14
Re: News on the ISO 13485 revision

Thank you Mr. Marcelo for the news.
It is nice to have a discussion of latest updations.


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

Ajit

Sure it is, the meeting ended yesterday, I only know because i was there :-)

Anyway, i just made this quick comment so our Cove members could begin to collect their comments on possible modifications. Maybe we could open a thread on this so people can freely comment. I'm sure the members of the Cove could greatly help giving their views of problems and solutions.
Thanks to Harigovindan for your informative Post and/or Attachment!
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  Post Number #35  
Old 26th March 2012, 02:16 AM
red66climb's Avatar
red66climb

 
 
Total Posts: 31
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Will the work proposal and survey be posted publicly? Where can I find the website for WG1?
  Post Number #36  
Old 26th March 2012, 04:27 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,183
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Quote:
In Reply to Parent Post by red66climb View Post

Will the work proposal and survey be posted publicly? Where can I find the website for WG1?
Not all work is public. But you can find the status of the Standard here.

Status of ISO 13485 can be found here Work Programme."

Stijloor.

Last edited by Stijloor; 26th March 2012 at 04:32 AM.
Thank You to Stijloor for your informative Post and/or Attachment!
  Post Number #37  
Old 10th April 2012, 05:24 PM
gramaley

 
 
Total Posts: 85
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

Thanks Marcelo, it is good that you allow us to know what is going in the WG. It affects so many of us and for different reasons too.

The FDA Voluntary Audit Program using ISO 13485 is posted on the FDA website. The FDA will begin to accept audit reports from the EU Notified Bodies. In exchange, the FDA will give the manufacturer one year off from routine QSIT inspections. What makes no sense to me is, they rarely inspect anyone outside the US, and since bad companies abroad don't need a QSIT inspection to sell in the US, these companies can sell, sell, sell, into the USA and FDA and like the other two attempts, this one will be scuttled too.

I was told by a person working at the EU Commission that ISO 13485 would continue to remain recognized. This was a recent decision that followed careful review of issues raised by Sweden and others. The European’s are struggling with other issues around ISO 13485, which have nothing to do with the standard itself, but how competency of auditors is to be determined, and by whom. The irony is, the European cooperation on Accreditation now have the ability to provide support for ISO 13485, but some regulators in Europe are concerned they will be losing their jobs to their accreditation body enforcers. It’s far more politically charged than it should be. They should all be working together.

It should be understood that no one gets the CE mark because they meet ISO 13485, or even EN ISO 13485. You don’t even need a QMS to sell most products into Europe; it’s just the smarter way to go about it.

CE marking may use 93/42/EEC Annex II Full Quality Assurance, or Annex V - Production quality assurance (no design controls) and these annexes benefit from ISO 13485's standardization. However, ISO 13485 cannot be used as a substitute for criteria that is laid down in the legislation, even when ISO 13485 supports requires conformity with national/or regional regulatory requirements. For example, if you make implanted medical devices, and the revised directive requires retaining records for 15 years, you must comply with this to meet the MDD Annex II. If however you are found not to meet this Annex II requirement, and you sell implanted device to Europe, you will not only be in violation of Annex II, you will also be issued a nonconformity against ISO 13485, since ISO 13485 requires regulatory compliance within the jurisdictions where you sell your medical devices.

It’s confusing, but it can be said that although ISO 13485 is extraordinarily valuable for aiding in QMS regulatory compliance, even in Europe, it is not recognized in Europe for being used in place of ANNEX II or ANNEX V CE certificates. ISO 13485 supports the consistancy of application of the QMS accross all manufacturers, since it is much better organized than the QMS sections of Annex II and V.

I have not seen the EN ISO 13485:2012, but it should have an Annex Z to show where it can be used for compliance within 93/42/EEC. All EU harmonized standards are supposed to have an Annex Z, to show what part of the directive it covers.

Other countries however do require or recognize ISO 13485 as a regulatory instrument (Health Canada, TGA Australia, and many other countries are beginning to turn to it, especially as the new IAF Accreditation System for gets underway this June.
Thank You to gramaley for your informative Post and/or Attachment!
  Post Number #38  
Old 10th April 2012, 05:58 PM
Ronen E

 
 
Total Posts: 3,091
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

@ gramaley: How much of all this is hard fact?

I see 2 points of slight misinterpretation:

Quote:
In Reply to Parent Post by gramaley View Post

You don’t even need a QMS to sell most products into Europe; it’s just the smarter way to go about it.
Assuming you referred to medical devices - all but plain class I devices require some sort of QMS (be it an annex II, V or VI one). True, ISO 13485 compliance is not mandatory, but for such devices one of these annexes has to be complied with and they all pose QMS requirements. Edit: Strictly speaking, there are other routes (involving annexes III and IV); however, these are so much more inefficient and costly for the manufacturer (for most types of devices) that they are almost irrelevant. I don't have hard data on this, but I take the risk and speculate that the percentage of manufacturers using any of these "non-QMS" routes (for non-plain-class-I devices) is <10.

Quote:
In Reply to Parent Post by gramaley View Post

Other countries however do require or recognize ISO 13485 as a regulatory instrument (Health Canada, TGA Australia...
The Australian regulatory system regards ISO 13485 in a manner almost identical to the way the EC system does. The Australian regulations spell out the QMS requirements without relying on ISO 13485; On top of that there is a ministerial order that recognises ISO 13485:2003 and provides presumption of conformity with relevant requirements (13485 compliance is voluntary). By all means an ISO 13485 certificate does not replace a TGA conformity assessment certificate.

Last edited by Ronen E; 11th April 2012 at 05:07 AM. Reason: One very important "not" was missing...
  Post Number #39  
Old 10th April 2012, 07:05 PM
gramaley

 
 
Total Posts: 85
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

I'm not sure about any questions I might have raised regarding Australia. I just know they now recognize IAF based accredited ISO 13485 certs. ISO 13485 accreditation requirements will go into affect worldwide this June, but this concerns Accreditation Body and CAB requirements. ISO 13485 has not changed, so manufacturers have nothing to worry about, other than who is certifying their company, and whether it operates under the IAF umbrella of accreditation. You can look at the IAF requirements of MD8 and MD9, which are free to download from the www.IAF.nu website. The IAF can root out phony ISO 13485 certs, since they have 66 member countries' accreditation bodies now working on it. These are some hard facts you can verify at the IAF website.

EC-Verification and Annex III and IV Routes
Actually, you really don't need a QMS certification to Annex II or V to get a CE mark, regardless of how high risk your device is. This is a relatively unused, but not necesarily useless option for a manufacturer to explore.

For a start-up company selling their first MRI to Europe, with no QMS, or a company that can't wait a year to setup their first QMS, but want to fill an European distributors sales order with a profitable, single batch, the EC Verification route makes a lot of sense. This route is more commonly used for Class IIa or IIb products, but can be used for class III devices as well.

Lower risk devices do not need to combine Annex III with IV, but its clear that annex II and V can be avoided.

1. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the
manufacturer shall, in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or

(b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) the procedure relating to the EC verification set out in Annex IV;

or (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).
Thanks to gramaley for your informative Post and/or Attachment!
  Post Number #40  
Old 11th April 2012, 05:04 AM
Ronen E

 
 
Total Posts: 3,091
Re: News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

@ gramaley:

I don't disagree with anything in your last post.

The Australian regulatory system does recognise valid ISO 13485 certificates. No dispute here. On the other hand - that's all it does; it doesn't rely on it nor does it mandate it. The phrasing in your previous post had the appearance of suggesting that the Australian system regards ISO 13485 differently to the EC system, so my point was to clarify that at concept level it doesn't.

With regards to -

Quote:
EC-Verification and Annex III and IV Routes... This is a relatively unused, but not necesarily useless...
Exactly. It's not completely useless...

Cheers,
Ronen.
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