News on the ISO 13485 revision - 2011 - 2012 (now 2014?)

[Marcelo Antunes]

Regarding harmonization, and particularly harmonization of US FDA QSR and EU rules...is that specifically an issue for this ISO 13485 revision cycle?.

Issue? Not at all, but we are talking two different levels of harmonization here. ISO 13485 has always been aligned with the EU requirements and also with the FDA requirements for quality systems. And it will remain aligned (I commented something on the history of this in this post - http://elsmar.com/Forums/showpost.ph...90&postcount=6) - there´s still some different points that will be corrected in the revision. This does not mean that the requirements are the same, but they require the same thing and if correctly applied the quality system will fulfill both. It also does not mean that FDA will dump one in favor of the other - the second level of harmonization, let´s say.

But, from what I´ve heard (and I also do not know the full politics of the agency) yes, there´s historically been somewhat of a fight of understandings regarding harmonization, and there´s a lot of different views on the subject.

[Marcelo Antunes]

Anyway, this is another important aspect that people usually forget (hence a lot of the comments in the survey) - WG1 only works with creating the standard, not it´s use in the regulations. So it does try to create an harmonized standards so regulators can, if they want, use it as quality systems requirements for their reg system. So there´s only so much the group can do.

[Cathie]

Marcelo,

Thank you so much for your "informal" comments. Looking forward to hearing more about the potential changes.

Cathie

[certified1]

My company will have its preasessment audit on March 7 for ISO 13485. What if these revisions to 13485 are implemented before our registration audit. Will we have to implement them into our QMS before we can proceed with the final audit registration?

[howste]

In Reply to Parent Post by certified1

My company will have its preasessment audit on March 7 for ISO 13485. What if these revisions to 13485 are implemented before our registration audit. Will we have to implement them into our QMS before we can proceed with the final audit registration?

No, the current standard will still be valid. There will always be a transition period.

[Marcelo Antunes]

And the revised document is targeted to be published at the end of 2014.

[Tamboussamy K]

Hi there,
Actually BS EN ISO 13485 : 2012 has been published in March 2012. But still ISO/CD 13485 ( revision of ISO 13485:2003 & Cor 1:2009 ) is under Committee stage ( close of voting / commenting period ) and may take few more months to be got published.
Sam
Tamboussamy K

[Marcelo Antunes]

Hello Sam and welcome to the Cove!

This thread is about the international, ISO version of the standard, which is being revised and will be published in 2014, probably.

There are other threads here which deals with the publication of the EN version in 2012 - this one, for example.