Interesting Discussion IAF CertSearch Database - Repository of "properly" Accredited Management System Certs

Did your organization receive an invite to be listed in the IAF Certsearch database?

  • Yes, and we want to be listed

    Votes: 0 0.0%
  • Yes, but we don't want to be listed

    Votes: 0 0.0%
  • No, but we want to be listed

    Votes: 3 30.0%
  • No and we don't care

    Votes: 1 10.0%
  • Database? what database?

    Votes: 6 60.0%

  • Total voters
    10
  • Poll closed .

Ronen E

Problem Solver
Staff member
Moderator
#11
Hi,

From a mdical devices perspective, I think that if we'll have a reliable database for "just" ISO13485, it would be a big step forward, and that step will become more and more significant over time. In fact, it may change the rules of the game.

First off, ISO 13485 is very prevalent as it is now. Even systems such as the USA one, which basically rely on a different requirement set (e.g. 21 CFR 820) are already endorsing ISO 13485 to an extent. The EC system is practically ISO 13485 based. AFAIK there are only a handful significant markets that "resist" ISO 13485, and are expected to continue to do so for long. Further, if such a database is available, one of the first logical steps in assessing a potential supplier would be checking whether they have a valid, "good" ISO 13485 cert. If no such DB is available for "competing" certificates, it's likely that over time clients would tend to be more comfortable with ISO 13485. True, commercial preference alone won't beat regulatory requirements, but I believe that given enough time authorities will also see the benefit and may eventually converge.

Perhaps I'm just naive.

As far as pharma goes, I don't think they have an ISO parallel for 13485. Some use 9001 enhanced by things like ICH guidelines, some modify 13485 itself. Additionally, pharma is historically more strongly regulated than medical devices, so regulations abound for it, and what we usually term as QMS is just their almost-century-old GMP, which is by now almost carved in regulatory stone, so to speak. I think CERTO will be useful mostly from the commercial aspect, less from the regulatory one. In that sense maybe the pharma industry won't benefit from it too much, except maybe when sourcing things like packages, production equipment and supporting services such as warehousing and shipping.

Cheers,
Ronen.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#12
Looking back over time, the trend towards consolidation/harmonization increases as the world continues to "grow smaller". I'm sure that some complexity will continue for quite a while but the trend is clear and has been for many years. When I started in quality there was no ISO 9001. I dealt with "mil specs". These days even the DoD uses it for some things and has since the mid-1990's.

I can't say I have been following medical device regulations closely enough to really know the interactions of the different requirements in different countries and how they fit together. I got my first "lesson" not so many years back when Marcello got involved here. Prior to that there wasn't much here in medical devices. Now it's become one of the most active topics. Note that Marcello provided the categorization for the current medical device related forums here and did a lot of work back then moving threads to the forums I created from his outline.

As to the ISO CERTO Database, I'll reserve judgement until it's online and working. Obviously my view is a bit jaded from efforts in the past to put together a database for ISO 9001 registered companies. IF the ISO folks can get the ABs and CBs to actually provide information that isn't "dated" and thus somewhat useless, I can see the benefit. The problem will be getting timely information with regular updates (at least monthly) from ABs and CBs. It will be an added cost to them to do so. Then again, as computers are so prevalent these days it should be doable.

None the less, with regard to ISO 9001, my opinion is it won't play a large part due to its broad scope of application and the number of companies doing registrations many of which aren't accredited by any authoritative AB. ISO 13485 is - in my opinion - much more likely to be of significant value to have access to in a centralized database. Being specific to a highly regulated industry is the key factor.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#13
I also mentioned that only time will tell is this initiative will succeed or not. A few years ago, another private-driven initiative was attempted and I predicted it's demise without much difficulty. The World Preferred database also lost it's ways when people realized that, because of the lack of policing, the data became extremelly unreliable.

If the ISO CERTO database goal is just to keep tabs on certificates, they have a chance to succeed if the IAF mandates CB's to enter and maintain data in a timely manner and the AB's police the CB's performance in keeping the data up to date and accurate.

Still, that would have only limited impact in keeping the players accountable to the goal of certificates being associated with supplier confidence. For example, the case depicted in the Trusting ISO 13485 Certification of a Supplier... A Sad Story thread would be basically the same with the CERTO database, or not. Now, if the CERTO database had the feedback mechanisms that are available in the OASIS database and the customers of the ISO 13485 certified company subject of that thread could have engaged with the supplier CB and easily escalate the concern to the AB (RvA in that case), things might had turned differently.

A (reliable) database is good, but what we really need are mechanisms that enhance the correlation of certification with confidence in the supplier's system.
 
M

Michael Drechsel

#15
This is just for information and clarification: There is no decision yet about the implementation of the CERTO-Database.

During the last ISO GA, it was decided to start a pilot project and the first results will be probably presented during the next ISO GA in Rio de Janeiro in September 2014. A adhoc-group was established with participation of several interested parties (e.g. ISO members, ISO staff, IAF, CB representatives (IQNet, IIOC), ..).

The pilot project is based on ISO 22000 data but the idea is to use it for other accredited standards. There are still heavy discussion about the involved risks and benefits as well as about the related costs.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#16
There are still heavy discussion about the involved risks and benefits as well as about the related costs.
Maybe a typical case of Wikipedia reference-linkanalysis paralysis? I contacted ISO almost 10 years ago (still have the email exchange to prove it) about such database. They thought it was a good idea then.

For some reason (China numbers may be?), they have been extremely slow to move forward with something that, IF WELL EXECUTED, would be a major boost for ISO's brand.

Maybe they are unsure if they can execute this adequately, but, on the issue of costs, I have no doubt that this database could become another revenue stream generator for ISO (and the IAF), if properly developed. How much does ISO spend with the annual compilation of the ISO Survey? With such database, the ISO Survey would be redundant.

Instead of selling ISO Standard Draft Documents to improve their revenues, ISO could make this ISO CERTO database a major revenue source, as long as they are willing to manage the risks of getting more closely associated with the Conformity Assessment Sector.

I have several ideas on how ISO could capitalize on this, while boosting their brand in a major way. But they seem too slow to embrace change and innovation.
 

Ronen E

Problem Solver
Staff member
Moderator
#17
They thought it was a good idea then.
You are more clever than that. The fact that they told you "they think it's a good idea" doesn't mean they really thought so. "Money talks and BS walks".

Maybe they are unsure if they can execute this adequately
I'm guessing that this is the real reason. It seems quite easy to fail in such an endeavour, and the consequences for their reputation can be significant. In short, the risk is high.

this database could become another revenue stream generator for ISO (and the IAF), if properly developed.
I understand that it's a costly exercise and that funding is key; however, I really hope that their funding model will not be based on membership fees charged from customers wishing to verify their potential suppliers' certificates (Naive? Looking for freebies?... Maybe :lol:). Otherwise it may become as annoying as the GMDN paid database. Rather, I think there should be some sort of fee for the certificate holders - in a way it's like a good, targeted advertisement.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
This is just for information and clarification: There is no decision yet about the implementation of the CERTO-Database.

During the last ISO GA, it was decided to start a pilot project and the first results will be probably presented during the next ISO GA in Rio de Janeiro in September 2014. A adhoc-group was established with participation of several interested parties (e.g. ISO members, ISO staff, IAF, CB representatives (IQNet, IIOC), ..).

The pilot project is based on ISO 22000 data but the idea is to use it for other accredited standards. There are still heavy discussion about the involved risks and benefits as well as about the related costs.
Thanks for the extra info, Michael!

It just shows the importance of verifying posted information...

I guess that's it for my hopes for an ISO 13485 database in the foreseeable future :(

Cheers,
Ronen.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#19
I'm guessing that this is the real reason. It seems quite easy to fail in such an endeavour, and the consequences for their reputation can be significant. In short, the risk is high.
As I mentioned several times, the IAQG-driven OASIS database is PROOF that, from a technical standpoint, it is doable, manageable and achievable.

From a revenue generation standpoint, the OASIS database is a GREAT example as well of how significant funding can be streamed. The risks are manageable and the potential reward is huge, both from a branding and financial standpoint.

What we need is Vision, resolve and applied knowledge.
 
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