New Trend of not seeking Official ISO 9001 Registration

[hogheavenfarm]

Re: New trend of not seeking official registration

Also note that per ISO's own data, the trend from the past decade plus has been a negative one for the ISO 9001 series, so we would do well to keep watching this.

(annual growth-absolute numbers)
North America 2003- (-13,621), 2004 (+9,777), 2005 - (+9,701), 2006 -(+1,773) , 2007 - (-13,836), 2008 - (+296) , 2009 - (-5,949) , 2010 - (-5,315) , 2011 - (+898), 2012 - (+1,056) , 2013 - (+9,993), 2014 - (-7,120) , 2015 - (5,479)

Gain 2003-2015 - 68,973 , loss 2003-2015 - (-45,841) , net (loss) - (-6,868)

 

[Sidney Vianna]

Re: New trend of not seeking official registration

Also note that per ISO's own data, the trend from the past decade plus has been a negative one for the ISO 9001 series, so we would do well to keep watching this.

But this is NOT a new trend. Just have a look at the discussion I started - Reasons for the Decline of ISO 9001 Registrations in North America - over 6 years ago.

 

[hogheavenfarm]

Re: New trend of not seeking official registration

You are correct Sidney, and yes I remember the thread,(I probably posted on it then) but 6 years ago there was not as much of a trend as is visible now, remember that 2008 version was really mostly cosmetic changes, the big change was the 2000 version. Now the big change is the 2015 version, it will be interesting to watch whether this accelerates or puts the brakes to this.

 

[Sidney Vianna]

Just to help visualization of the trends, since 1993 thru 2015 (latest ISO survey data available as of today), see below. Keep in mind that, as discussed numerous times, confidence on the accuracy of the numbers is questionable.

 

[Marc]

The graph is total registrations, not "new" registrations, correct, Sidney?

 

[Sidney Vianna]

Yes, Marc. Total registrations reported per year, i.e., cumulative. Not new ones.

Source: ISO Survey https://www.iso.org/the-iso-survey.html

 

[Marc]

It would be interesting if number of registrations could be categorized according to company size by number of employees...

 

[Wes Bucey]

I haven't noticed this trend but I will start paying attention to it now.

Unfortunately I see this as a result of the ever increasing layers of certification and the associated costs that go along with it. As new standards are being released and others are updated, costs to maintain certification keep escalating. With the MDSAP system, now two auditors will be in attendance plus the submission of the files beforehand. Throw in the unannounced audits both upstream and downstream and you can see how the small companies will be squeezed out. The FDA is supposed to be weaned off the public purse and should become financially self-sufficient through increased fees (according to some national leader whose name escapes me at the moment).

The release of the MDR in Europe may (or will depending on your view) cause the smaller companies to abandon the European market or find strategic partnerships to enter. Razor thin margins cannot sustain such business practices. A good contact of mine has already suggested that the one or two person design shop will be forced out because of the cost and resource commitment.

When I was a licensed healthcare professional, I helped initiate our regional regulatory body. A member of the council mentioned that the licensing fees could be $10,000 annually and those who wish to practice would have to pay it as a necessary cost. What they didn't realize is that the market for these essential but few professionals would collapse as the average practitioner wouldn't pay it.

Sorry for the rant but I'm in training to become a curmudgeon...

All good points, BUT you missed one important factor - Canadians cannot be curmudgeons. They have a law against that, don't they? Eh?

 

[Golfman25]

One only need to read these boards to see why the trend is down. How many times are we really talking about nothing more that semantic arguments. We miss the big picture -- How well are you doing. Rather we focus on "what does this mean?" Then auditors arrive and want things done to simplify their audit -- charts, graphs, written procedures, etc. As a business owner you eventually ask "do we really need all of this?" When the answer is no, they become part of the trend.

 

[SpinDr99]

A while back I used to travel to China. You were always able to tell the truly certified companies from outside of their building. They were the ones with the permanent "ISO-9001 Certified" signs. The others had banners which were quickly taken down. Any Quality Manager worth his dime can easily tell when a "compliant" company is really compliant. To claim compliance without being fully compliant is wasting everybody's time.

However, a truly compliant company will save significant cash by not getting certification and be able to pass that on to their customers. It only really costs them a few more minutes completing a Supplier Survey rather than attaching a copy of the cert.

As mentioned, there are those CB's whom are lax in their requirements during an audit, and are pushed to get the contract for new business. They will always be out there, which is why it's important to get a highly reputable CB.