No CE Mark in supplier = Nonconformance

[Antonio Vieira]

Hi all!

In Europe it’s necessary to have as a statutory requirement the CE Mark in almost all products. It's fundamentally a safety and health requirement.
In one of my clients we had a nonconformance because, even thought we had written in our purchasing orders the necessity of that requirement, the company that we are used to buy one sub product, refused to make the necessary arrangements in order to get that CE Mark in that product (witch is not very expensive and easy).
Anyway, as we couldn’t stop production and the only alternative supplier we CE Mark in that product is more that 200 km away, with prices over 3 times more expensive, we contacted our customers about this and as they said there was no problem, we decided to buy that usual supplier.

I know perfectly well that ISO 9001:2000 7.2 states clearly that we “the organization has the ability to meet the defined requirements”, but this is a case of doing it for much more money, or probably stop doing it!
Is it our fault that we can’t find anybody that can supply that product in good economic and regulatory conditions?
Shall the company close the door?
Isn’t the registrar organization trying to “build the house starting by the roof”?
:mg:

 

[Paul Simpson]

Duty

Hi all!

In Europe it’s necessary to have as a statutory requirement the CE Mark in almost all products. It's fundamentally a safety and health requirement.
In one of my clients we had a nonconformance because, even thought we had written in our purchasing orders the necessity of that requirement, the company that we are used to buy one sub product, refused to make the necessary arrangements in order to get that CE Mark in that product (witch is not very expensive and easy).

Need a little more information Antonio. To what directive should they be claiming conformance by applying the CE Mark? It may be they can merely issue a declaration of conformity. Even so it is the supplier that is breaking the law by not applying the mark (if it is required).

Anyway, as we couldn’t stop production and the only alternative supplier we CE Mark in that product is more that 200 km away, with prices over 3 times more expensive, we contacted our customers about this and as they said there was no problem, we decided to buy that usual supplier.

I would contact your alternative supplier and ask how their competitors can get away without CE marking.

I know perfectly well that ISO 9001:2000 7.2 states clearly that we “the organization has the ability to meet the defined requirements”, but this is a case of doing it for much more money, or probably stop doing it!

If you are supplying a product that carries CE marking in itself then you are taking the overall responsibility - even if the supplier has a duty - see above.

Is it our fault that we can’t find anybody that can supply that product in good economic and regulatory conditions?
Shall the company close the door?
Isn’t the registrar organization trying to “build the house starting by the roof”?
:mg:

Again it is unusual for a registrar to look at CE marking under an ISO 9001 banner if it only applies to health & safety. Some CE Marking however relates to product performance and compatibility - e.g. Electromagnetic Compatibility (EMC)

 

[Don Palmer]

Your the consultant...

Hi all!

In Europe it’s necessary to have as a statutory requirement the CE Mark in almost all products. It's fundamentally a safety and health requirement.
In one of my clients we had a nonconformance because, even thought we had written in our purchasing orders the necessity of that requirement, the company that we are used to buy one sub product, refused to make the necessary arrangements in order to get that CE Mark in that product (witch is not very expensive and easy).
Anyway, as we couldn’t stop production and the only alternative supplier we CE Mark in that product is more that 200 km away, with prices over 3 times more expensive, we contacted our customers about this and as they said there was no problem, we decided to buy that usual supplier.

I know perfectly well that ISO 9001:2000 7.2 states clearly that we “the organization has the ability to meet the defined requirements”, but this is a case of doing it for much more money, or probably stop doing it!
Is it our fault that we can’t find anybody that can supply that product in good economic and regulatory conditions?
Shall the company close the door?
Isn’t the registrar organization trying to “build the house starting by the roof”?
:mg:

Hi António, what have you advised your client to do about this. IMHO, Registrar bashing ("Isn’t the registrar organization trying to “build the house starting by the roof”?") doesn't help your customer solve their problem. I'm certain you know that any worthy structure begins with a solid foundation. Consider, using your valuable talents as a consultant/engineer and help your customer find an appropriate answer that is in-line with their business goals and remains true to the standard.

 

[Antonio Vieira]

Thanks.
By the way Paul, this “famous” product is just sand and rocks to be used in the preparation of concrete to fill the holes for electricity columns.
The Directive is 89/106/CE for construction products. We already knew this was going to happen with this registrar, but I find it very stupid. This directive was made to construction of buildings and it’s being used to get ISO 9001 nonconformances everywhere concrete is used...

This is being happening in other small companies like this one, that just “were sent” to ISO registration by imposition of the Electricity Company.
Some of them are considering getting out of “this system”, because it’s becoming too expensive. Their products are not getting any better, but specially are getting much more expensive.
I’m sure this not the purpose of ISO 9001:2000 even considering that efficiency is not one word we can find in the standard...

Dear “Muleskinner”, of course that I’m going to advice this customer that he has to buy to the supplier that sends the product with CE Mark. This is not the problem.
The problem is that he is not very happy with quality..., or at least this kind of quality.,,

 

[Don Palmer]

Yes, I understand.

Dear “Muleskinner”, of course that I’m going to advice this customer that he has to buy to the supplier that sends the product with CE Mark. This is not the problem.
The problem is that he is not very happy with quality..., or at least this kind of quality.,,

Yes, António, I understand and empathize with you and your client. If your client is unhappy with the registrar's interpretation of the standard, that is one thing, and can and should be dealt with in a proactive way. Help your client respond conformity to the registrar's nonconforming statement.

 

[Sidney Vianna]

Did you forget the LAW?

Hi all!

In Europe it’s necessary to have as a statutory requirement the CE Mark in almost all products. It's fundamentally a safety and health requirement.
In one of my clients we had a nonconformance because, even thought we had written in our purchasing orders the necessity of that requirement, the company that we are used to buy one sub product, refused to make the necessary arrangements in order to get that CE Mark in that product (witch is not very expensive and easy).
Anyway, as we couldn’t stop production and the only alternative supplier we CE Mark in that product is more that 200 km away, with prices over 3 times more expensive, we contacted our customers about this and as they said there was no problem, we decided to buy that usual supplier.

I am very surprised with this. The European Directives carry the power of LAW. What you just described (collusion of customers and suppliers) represents "conspiracy" to bypass a REGULATORY requirement. If the legislation requires certain products to be "CE-Marked", anything short of that is failure to comply with REGULATORY requirements. Which ISO 9001 addresses in several paragraphs. If "rock and sand" seem unimportant, I would like to bring to your attention that several buildings around the world, especially in the developing world, have had dramatic structural failures, many of them traced to improper use of building materials and materials that are not up to spec. This is definitely something that has SIGNIFICANT safety implications. I am really surprised with this post. In the US this would have tremendous legal implications.

 

[Antonio Vieira]

Do you know how to achieve the CE mark in one product like sand?
It’s not a certified product, it’s just one conformity declaration made by the producer, it doesn’t mean a thing.
All you have to do is to make a test, for example once a year, and then you have conformity all the time.
That’s the main reason I think this is a “Mark” with zero value...
It’s what I told in the beginning “building the house starting from the roof”!
AV

 

[Sidney Vianna]

So, if is that simple, why didn't the supplier comply with it? Irrespective, consciously disregarding the law is a poor risk management strategy. As far as I can tell by your description of the situation, the registrar is 100% correct.

 

[Antonio Vieira]

The supplier is just one guy. He takes the sand out of a river and sells it.
To make the so called CE Mark, it will cost him some money – should he close his business also?
If you want another supplier, with that declaration of conformity, you have to pay much more (3 or 4 times more) for the same product. And if you’re able to find one...

It's the only registrar that is doing this thing here. The solution can be change for another one. (that's what everybody is doing)
This registrar is not doing this to improve quality; it's just to have more things to write in their audit reports. This has no value added for this kind of industry.
Anyway we write that we want the CE Mark in the product, the supplier doesn’t sell it with that conformity. What can we do?

I’m not saying that the registrar isn’t right, what I’m trying to explain is that they are not going to go anywhere with this thing...
I'm also an auditor, and for irony for the same registrar, and my opinion this is no more than the so called “fashion finding in audits”. Where is the main quality of an auditor – the common sense?

 

[Don Palmer]

I'm also an auditor, and for irony for the same registrar, and my opinion this is no more than the so called “fashion finding in audits”. Where is the main quality of an auditor – the common sense?

Uh-oh, did you just say you are representing a client as a consultant while at the same time working as an auditor for the same registrar who holds your client's certification and audits them? How can a registrar provide both consultant services and audit services to the same client at the same time? I've always thought this was taboo (conflict of interest). Would someone please explain. Have I misunderstood the text?