Tracking New ISO Document Releases

M

mlaurie

#1
We recently had our 13485 re-cert audit, An auditor had “Observed”, but did not cite a NC, that we did not have the latest 14971-2012 in our controlled document list.

My response is 1) I didn’t know of the new release and 2) shouldn't our Registrar that is contracted to do the auditing be providing a notification of new requirements they will be auditing to.

I understand it’s not the responsibility of the registrar to provide notification, (they do send “Advisory Notices” sometimes) so where do I go to find out any new ISO requirements /updates, and is there a site that will automatically e-mail notifications?

Sarasota Mike
 
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qusys

Trusted Information Resource
#2
I do not think so.
ISO 14971 is integral part of ISO 13485 and recalled in 7.1 clause for the product risk assessment during all life-cycle of the device.
It can be seen as a document of external origin , so it should be part of your QMS and up to dated to the last version.
Just in case of update, you shall mantain comply your QMS complying with eventual new requirements.
Besides, your organization shall also mantain up to date the competence of personnel and if there are major changes in the standards, you shall provide training and formation.
As to ISO14971 , I do not know if there were major changes that could have carried to make training and include new requirements in your organization. If so, you should put in place an activity/process for this, led by Quality.
As to your case, you can visit the website of ISO www.iso.ch to check the latest version of the standard.
 
Last edited:

Mikishots

Trusted Information Resource
#3
We recently had our 13485 re-cert audit, An auditor had “Observed”, but did not cite a NC, that we did not have the latest 14971-2012 in our controlled doc list. <snip>
To follow the method of "I'm going to use this version until someone tells me there's a new one" is not considered a good manufacturing practice.

You make periodic checks. You're responsible for ensuring that the standards you are using are up to date. Email notifications? Typically not, they're not in that business.

For me as an example, I visit the SAE Aerospace Standards listing before each and every audit I do. I also go to the ASTM site, the ISo_Org site and any other site that has the standards we use. Bookmark them - it takes literally five seconds to check.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
We recently had our 13485 re-cert audit, An auditor had “Observed”, but did not cite a NC, that we did not have the latest 14971-2012 in our controlled doc list. <snip>
Hi,

Was it "pure" ISO 13485, or part of EC certification?

There is no 2012 version to ISO 14971. The auditor was probably referring to EN ISO 14971:2012. The latest revision of ISO 14971 is 2007. If that was just a stand-alone ISO 13485 audit, you're probably all right (that might be the reason for recording an observation rather than a NC). If the audit was in a broader EC certification context, you probably want to quickly get acquainted with EN ISO 14971:2012. Look at the "Z annexes" to find your bearings.

Further, ISO 13485:2003 7.1 specifically designates ISO 14971 as a sort of guidance:

NOTE 3 See ISO 14971 for guidance related to risk management.
Guidance is not mandatory and IMO you shouldn't get cited for merely not utilizing it. The important aspect is compliance with regulations and normative sections of standards; how you do it is mostly up to you as long as you can demonstrate that the binding requirements have been met. Even in a CE certification context, EN ISO 14971:2012 is a harmonized standard, and as such it is not mandatory. It is just one possible way to comply. In the past I would have tended to say "easy way", but given all the mess around EN ISO 14971 harmonization (which ended with the endorsement of the outrageous 2012 patch), I'm no longer convinced it is that easy, or even worth the effort. As already suggested in other threads here, perhaps one better resort to the bare directive's text (Essential Requirements) when it comes to risk management.

Cheers,
Ronen.
 
M

mscottf

#5
Our company recently had a similar experience where, in the midst of an audit for a CE Mark submission, EN ISO 14971:2012 was released and the auditor insisted that we justify our use of ALARP on our FMEAs. The Z annex in EN ISO 14971:2012 does not allow for ALARP, but insists on ALAP. We reviewed all our FMEAs and other risk documents and were able to satisfy the auditor with some revisions and explanations.

TechStreet is a web site that sells standards and guidance documents. They also have a free service called "My Tracker List" where you can enter all the standards that you want to track and they send you an e-mail to notify you of new releases. I have used it for a year or so, and it works fine. The hard part is keeping track of the harmonized standards like this one. If you own ISO 14971, then the release of EN ISO 14971 would not trigger an e-mail.

It requires some active effort to monitor and manage a large list of standards; we have about 200 and it takes some time.
 
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