NB's auditing practice called into question...

I am an engineer for a small (<50 employees) medical device manufacturing plant. I am currently working on an R&D project that will be ultimately affected by this updated revision of ISO13485:2015. (according to BSI white pages) Normally a Gap Analysis would be the general course of action for me/us to take to ensure compliance, however; here is the situation - Our NB has indicated that we will be audited on both the ISO13485:2012 (amendments) and ISO13485:2015 this fall and the ISO13485:2015 revision is to be released in the fall. My question is; where is the time needed to complete any gap analysis especially if we are audited prior to the release of 2015 revision? I feel this is just another way for NB's to buckle-up small medical device manufacturers. Does anybody have any direction for me on my situation? Thanks.

 

According to Marcelo, the new ISO 13485 version might be published as early as next month (February 2016).
http://www.qualityforumonline.com/forum/index.php?threads/iso-13485-revision.130/page-3#post-4019

...but I get your point. This is still very little time given by your NB.

Did you look at the draft when it was being developed? If so, perhaps you could use it as a temporary stand-in for the finalized version?

 

I am sure you meant EN ISO 13485:2012, as there is no ISO 13485:2012.

As for the NB unilaterally mandating compliance by the Fall to the ISO 13485:2016, they CAN'T do that. There will be a TRANSITION period for organizations to migrate their systems to the ISO 13485:2016 standard and, I suspect that the IAF will allow for a 3-year transition. During that transition period, YOU (the REGISTRANT) decides when you are going to make the move; not the NB, not the CB.

Once again, the NB can not unilaterally mandate you to transition if you are not ready.

 

No I did not Mark but I will see if QM(r) has a copy I can review. Thanks for the response. Jon

 

I am not sure who, how, or why this upcoming audit is in place that would be an alley I can look into. What I do know is that it will ultimately affect how to proceed with the R&D project's compliance activities. Thank you for your response Sidney, I have made the QM aware of your response and I have set up a meeting to specifically discuss this matter. Jon