ISO 13485 Revision

ISO TC 210 WG 1 will meet this week at London (in fact, it´s Wokingham, Berkshire, but it´s very near London) to discuss 22 pages of comments to finish the discussion of DIS2 and create the FDIS.

 

22 pages of comments sounds like a lot! Is that typical for DIS2? Is it possible to summarize the areas of greatest contention?

 

It´s not that much in fact because most of them are to correct some editorial inconsistencies. Some are for the correction of technical inconsistencies, which took more time to discuss. Anyway, we already dealt with all of them in 1.5 days, so it´s ok.

One of the problem that I was keen in discussing, but was not accepted, was the way risk management is required, not that we extended the scope of the standard to any organization in the medical device life-cycle.

Another one that I had to work yesterday after the meeting was to revise all instances of "product" and "medical device" so as to make sure that the ones that were applicable to organizations other than manufacturers did mention "product" and other focused on manufacturers (or treat product safety and performance) mention "medical device".

 

ISO9001:2015 + Context of the organization + relevant interested parties needs and expectations (Like the FDA / MDD / etc) can very well be equated to ISO13485. So why at all we need the ISO13485 in a new release that will be still old ... ?

 

Because ISO 9001 was not developed for regulatory purposes, and ISO 13485 is. Regulators are willing to use ISO 13485 (and the new version is exactly what they want to use), and not ISO 9001, in their regulatory schemes. So it´s not "old". It´s what is needed for the medical device industry. Regulators will NEVER use ISO 9001:2015 because they seem it as too "open", for example, removing almost all references to documentation, and that´s is totally different from what regulators and current medical device regulators expect.

 

If you want to try your suggestion, just drop your ISO 13485 compliance, use "ISO9001:2015 + Context of the organization + relevant interested parties needs and expectations" and see how many regulators will accept this approach to deal with the QMS part of medical device regulations. I would bet that not many, if one at all, would.

 

Hi Marcelo,
This subject area has cropped up in other places, as many medical device companies currently have dual ISO 9001/ISO 13485 certification. Do you think from a regulatory point of view; whether in the US, EU, Brazil etc, ISO 9001:2015 will be seen as incompatible with respect to Medical Devices ?
Steve

 

Yes, I´m pretty sure it will. In fact, my recent suggestions were that, if you do not have a good reason to keep ISO 9001, you probably should drop it.

What is important to understand is that current regulations are very prescriptive because that´s how regulators in the medical device area want it to be. Another reason is that most QMS regulations/expectations are from decades ago and were based on old standards. For example, 21 CFR 820 was based on the 1994 version of ISO 9001 and on the 1996 version of ISO 13485, which were heavily focused on documentation and other more prescriptive requirements. Even the medical device directives, which are from the 80s and 90s, have QMS requirements that were based on the current expectation at the time. For a regulator to use the more "open" ISO 9001" and accept that for regulatory compliance, they would need to change their regulation. The question is, why would they do it? Because ISO 9001 changed? And why change it if things are working until now and why change it for something that we do not know if it will work (as I mentioned in another thread, not one knows if ISO 9001:2015 will work as intended, I mean, surely certifications and the like will be kept, but there´s so much new and untested things that no one know if it will be god or bad).

 

As ISO 13485 (and the update) refers to ‘procedures’ and ‘records’, as does MDD 93/42/EEC (and the impending replacement Regulations); rather than ‘documented information’, this is an example of just one problem compliance area.

 

If the regulators love the new ISO13485 so much, why are they grouping to make and pilot test the MDSAP, which again is drawn out on the lines of 13485 + region specific requirements. 20 out of the 36 month of pilot MDSAP seems to have gone nowhere as I gather. After all the regulators have their documented requirements for the QMS and once the ISO9001 considers them as interested parties, the exact required documents come into QMS.
Seems to me that the regulators and the ISO do not see eye to eye. Suspicion prevails more than mutual confidence. When the IMDRF who are testing the MDSAP pilot are so choosy of the CB's (AO as per the MDSAP) that only the CMDCAS recognized CB are permitted to apply and become an AO., would the same regulators accept the new ISO13485 through any of the CB ? The new 13485 will be another big farce just like its previous version.

 

is there a site to go to that will allow our company to see what clauses are changing and what is being taken out. Would like to have something to follow to keep updated on the status of the new revision that's in draft ISO 13485:2015 DIS 2. My manager would like to bring this to the table at management review so we don't get hit at the last moment trying to make necessary changes. Thanks

 

I'm sure you will be given plenty of time to make the necessary updates to your system when it is released.

 

DIS 2 is available to purchase (118CHF) here -

http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752

although I would suggest holding out until the updates that Marcelo has detailed go through and the FDIS becomes available. As Nikki has said there will be several years of transition as well.

 

The FDA just released the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP), to provide the current status of the program’s performance goal and objectives. This is attached here.
From the report ....
PoCC No. 8 relates to the number of medical device manufacturing sites electing to participate in the program. Although Table 4 demonstrates a favorable trend, there is still one key factor affecting this outcome - manufacturer commitment to utilizing the program in order to decrease regulatory audits. The PoCC target of 10% means approximately three-hundred-thirty (330) medical device manufacturing sites have to express an interest in participating in the program by the end of 2016. As of 23 July 2015, forty-five (45) manufacturing sites have expressed interest in participating in the program. Program participation by medical device manufacturers appears to be the primary challenge at the mid-pilot review. Manufacturer participation is vital for the success of the program.

A total of 45 manufacturer sites have shown interest and participated. This seems a poor response per the PoCC No. 8 (proof of concept creation) pasted above from the report..

Why is this ? Where is the global reach of the AO's. How are the AO's competitive. From which regions would you expect the manufacturer participation ? Are the AO's well spread and promoting this MDSAP. How is the global spread of the 45 manufacturing sites so far as against the total population open for this pilot with the AO's.
At midpoint, if the 10% is 330 the expectation would have been 165 as against a meager 45. What can be changed now in the pilot to improve this to achieve the target of at least 10% of the AO's CMDCAS clients. Do you feel something was wrong in the concept creation or pilot implementation ... ?
For a pilot of this nature that has all the major regulatory also supporting, my take is that the >10% picked as PoCC (Whether a sufficient number of manufacturers participate in MDSAP) in itself is not an optimistic figure. For such a joint project a target of >30% would have proved its worth.

 

BSi have published a white paper on the changes:

Available here:-
http://www.bsigroup.com/en-GB/our-services/medical-device-services/BSI-Medical-Devices-Whitepapers/

(Free - but registration required)
Disclosure - no connections

 

To possibly continue Steve's thoughts above. With the current versions of 13485 and 9001, any company which is obliged to have 13485 (medical device manufacturers), has effectively been able to also have 9001 with no real overhead (except the money we pay to our NB). I wonder if with the divergence of the two standards, that this will change? Certainly I am considering our position.
One problem with making such a move however, will be that a good number of customers (hospitals etc), still seem to be unaware of 13485, although they do know of 9001!
Has anyone else had thoughts in this direction?
Thanks.

 

We have the 13485 and further got the 9001 for free from a reputed CB.
This year will be the same.
Come 2016 annual surveillance. we will check with our 13485 CB what their stand is.
As of now they have no clue.

 

Do we have an update on when/or if the FDIS will be published.

 

Expected at the end of October.

 

Nobody could accuse the TC 210 of rushing this revision