Harmonized Standards EN vs. IEC

D

DynaPur

#1
The company I work for sells to a VERY large global client that has requested CE Declarations of Conformity for all components within our electrical enclosure. We have provided several sets of documents provided by our multi-billion dollar electrical manufacturers/suppliers only to be told their DoC's are not valid for a variety of reasons such as the harmonized standard being out dated, the signatory did not list their title, DIN vs. EN vs. IEC standards... the list goes on. Over the past 5 months, we have learned much about CE but still cannot find answers to some very basic questions and I'm hoping someone can help.

1. Are IEC standards harmonized? Manufacturer = Yes, Client = No
2. Can the Low Voltage Directive and ATEX directive both be listed on a DoC.
3. What can a $4M/year company do when a $27B/year supplier insists their DoC is correct as is but the +$100B/year client disagrees?

I have more questions but will leave with these three for now. Any responses or suggestions on where to find answers and/or training would be greatly appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The company I work for sells to a VERY large global client that has requested CE Declarations of Conformity for all components within our electrical enclosure. We have provided several sets of documents provided by our multi-billion dollar electrical manufacturers/suppliers only to be told their DoC's are not valid for a variety of reasons such as the harmonized standard being out dated, the signatory did not list their title, DIN vs. EN vs. IEC standards... the list goes on. Over the past 5 months, we have learned much about CE but still cannot find answers to some very basic questions and I'm hoping someone can help.

1. Are IEC standards harmonized? Manufacturer = Yes, Client = No
2. Can the Low Voltage Directive and ATEX directive both be listed on a DoC.
3. What can a $4M/year company do when a $27B/year supplier insists their DoC is correct as is but the +$100B/year client disagrees?

I have more questions but will leave with these three for now. Any responses or suggestions on where to find answers and/or training would be greatly appreciated.
Hello and welcome to the Cove :bigwave:

I come from the medical devices field. FWIW:

1. IEC standards are not harmonized per-se. Some of them may be harmonized under an EN designation. Each Directive has an associated list of harmonized standards that provide presumption of conformity, look at this page: http :// ec. europa. eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm#h2-1. - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Nevertheless, the EC DoC may also list standards that are not harmonized. A manufacturer may be able to claim that a certain non-harmonized standard (an IEC one, if you like) is identical in its normative part to a harmonized one (EN), and the relevant NB may accept it; AFAIK its a matter of NB policy, but I may be wrong.

2. I have no specific experience with the ATEX directive. In general, if a single document meets all the applicable requirements listed in 2 different Directives, I don't see why it wouldn't be able to serve as the DoC for both.

3. That is a tough business question. I don't think the regulations and/or associated guidance could help with that. If you could somehow get the +$100B to talk directly with the $27B, it might help... Other than that it's always good to have alternative suppliers for critical components.

Cheers,
Ronen.
 
Last edited by a moderator:

CharlieUK

Quite Involved in Discussions
#3
What type of DoCs are you providing for components? - CE marking DoCs are for finished apparatus, not components.

Regarding what standards are on a CE mark DoC - the manufacturer may list whatever they like.

"Fully Applied" "Harmonised Standards" provide the manufacturer with a PRESUMPTION of conformity - no more and no less. Many Directives (inc EMC and LVD) do not require use of Harmonised Standards and others, such as R&TTE, allow use of non-Harmonised Standards where a Notified Body Opinion has been obtained.

Unfortunately for you, many large companies take the view that compliance with Harmonised Standards is the ONLY acceptable method for CE marking - this view is not LEGALLY enforceable, but is entirely enforceable COMMERCIALLY.

You might be buying components/items from large companies, but you are essentially a small company selling to a large one. You MIGHT have a chance of educating them, but more likely you need to give them what they ask for.

I'll repeat my initial question though - why do they need DoC's for components?
 
D

DynaPur

#4
Ronen & Charlie, thank you so much for your input! Do you know of any resources that could substantiate what you have stated regarding the standards not being required to be Haromonised? We have sent several supplier explanations as to why they are using the standards they listed to our client and all have been rejected. After going back and forth with the suppliers most have altered their DoC to match what our client wants. (Doesn't seem like the best idea to me but...)

Charlie, as to your question about why we are supplying our client with component level DoC's... their sales engineer apparently allowed his client in Egypt to add that level of detail into the contract so now, if they cannot provide the proper documentation, they are looking at not being paid or having to replace the parts that are deemed "non-compliant." As for our machine, we (as an ISO9001 company) self-declare CE on our finished machine. We conform to the EMC, LVD and Machinery directives. We have tested our machine to ensure it meets the EMC directive as required. We have provided our DoC for the machine and the substantiating test data but it is not enough.

Our biggest issue is we submit documentation to our client and they come back and say "unacceptable" and we start going back and forth trying to find out what exactly what would be acceptable. We have been using the Europa web-site as a reference but still be cannot find concise answers to specific questions, i.e. are IEC standards harmonized, is a type written name AND title required for the signatory, etc.

The bottom-line is we are trying to play by the rules but we don't know what the rules or who has the rule book.

Again, thank you both very much for your previous assistance and any additional assistance you could offer.:thanx:
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Ronen & Charlie, thank you so much for your input! Do you know of any resources that could substantiate what you have stated regarding the standards not being required to be Haromonised? We have sent several supplier explanations as to why they are using the standards they listed to our client and all have been rejected. After going back and forth with the suppliers most have altered their DoC to match what our client wants. (Doesn't seem like the best idea to me but...)

Charlie, as to your question about why we are supplying our client with component level DoC's... their sales engineer apparently allowed his client in Egypt to add that level of detail into the contract so now, if they cannot provide the proper documentation, they are looking at not being paid or having to replace the parts that are deemed "non-compliant." As for our machine, we (as an ISO9001 company) self-declare CE on our finished machine. We conform to the EMC, LVD and Machinery directives. We have tested our machine to ensure it meets the EMC directive as required. We have provided our DoC for the machine and the substantiating test data but it is not enough.

Our biggest issue is we submit documentation to our client and they come back and say "unacceptable" and we start going back and forth trying to find out what exactly what would be acceptable. We have been using the Europa web-site as a reference but still be cannot find concise answers to specific questions, i.e. are IEC standards harmonized, is a type written name AND title required for the signatory, etc.

The bottom-line is we are trying to play by the rules but we don't know what the rules or who has the rule book.

Again, thank you both very much for your previous assistance and any additional assistance you could offer.:thanx:
Hi,

I'm glad you found my post useful.

In my field - Medical Devices - most of these definitions are given in the directives, or in other specific EC legal documents referenced by the Directives, so it's only a matter of careful reading of not-too-many pages. I assume that would be the case with most other New Approach (leading to CE mark) directives. Well, maybe not so sure about the "not-too-many pages" part :lol:

Regardless, it seems that the "rule book" is not so relevant because you have an extra-picky client which seems to be bullying you (at least by how you describe it). Perhaps it's time to consider a different approach.

Sorry I can't help more than that.
Ronen.
 

CharlieUK

Quite Involved in Discussions
#6
Your DoC should be to:
EMCD and LVD
or
EMCD and Machinery Directive (MSD)

You don't declare to both LVD and MSD as they are applied "either/or".

Given that you have a machine and assuming that its not one of those listed in Annex IV, you can self declare.
Assessment for the MSD is based on an EHSR assessment against Annex I. This is typically done by applying(using and maybe testing against) some standards - these may or may not be Harmonised.
You will also need to perform risk assessment as to risks that may occur suring use.


The bottom-line is we are trying to play by the rules but we don't know what the rules or who has the rule book

The MSD is far more complicated than EMCD and LVD and if you are having trouble with a customer it may be because you have missed some part of the assessment. You can't learn enough about doing an MSD assessment by reading the web - I strongly recommend that you get yourself some expert, 3rd party help.
Where abouts are you based?
 
D

DynaPur

#7
Charlie,

Thank you again for your input. We are located in the US and do have a 3rd party that has performed the EMC testing and we are scheduling the same party to do some additional testing and provide some additional assistance. Regardless of our testing, the client is not interested in our DoC for the whole machine they are interested primarily in the components. Our other issue is that it seems that the client's compliance group and the third party they have had to hire to keep up with their own demands don't view documents the same way. This morning the 3rd party rejected a DoC on a current project that they had previous accepted on another project that had higher standards for acceptance. It is really becoming a coin toss to see if a document is acceptable.

Our biggest concern is providing the best possible product. We have designed our machine so it is very reliable and easy to operate. We have also looked to use only quality manufacturers whose product is available global so if there is an need to replace a part in the field it can be quickly source and easily replaced. ALL of the components that can be CE marked are CE marked but the supplier DoC just isn't up to par in many cases, at least according to this client. The client is looking to have us swap out one component for another purely based on a pretty piece of paper. We would prefer to keep what we have as the solution is proven, the components as well as the finished machine are reliable and safe. We are just at a point where we are banging our heads against a wall. In all reality, as I read what I just wrote, I don't think the "rule book" would help.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Charlie,

Thank you again for your input. We are located in the US and do have a 3rd party that has performed the EMC testing and we are scheduling the same party to do some additional testing and provide some additional assistance. Regardless of our testing, the client is not interested in our DoC for the whole machine they are interested primarily in the components. Our other issue is that it seems that the client's compliance group and the third party they have had to hire to keep up with their own demands don't view documents the same way. This morning the 3rd party rejected a DoC on a current project that they had previous accepted on another project that had higher standards for acceptance. It is really becoming a coin toss to see if a document is acceptable.

Our biggest concern is providing the best possible product. We have designed our machine so it is very reliable and easy to operate. We have also looked to use only quality manufacturers whose product is available global so if there is an need to replace a part in the field it can be quickly source and easily replaced. ALL of the components that can be CE marked are CE marked but the supplier DoC just isn't up to par in many cases, at least according to this client. The client is looking to have us swap out one component for another purely based on a pretty piece of paper. We would prefer to keep what we have as the solution is proven, the components as well as the finished machine are reliable and safe. We are just at a point where we are banging our heads against a wall. In all reality, as I read what I just wrote, I don't think the "rule book" would help.
As I wrote, maybe it's time for a different approach.

What is Quality?

One of my favourite definitions says "everything that makes the client happy". If this client is important to you, maybe you should listen to them, and listen good. Don't be "right", be clever. If they care more about the "fancy piece of paper" than about the machine being brilliant, then this should be your key to Quality, in this case. What good is a reliable and user-friendly machine that sits in the warehouse?... And if your organisation doesn't have that kind of flexibility, or will to have it, maybe you should let this client go.

My limited experience shows that when dealing with big clients, you could be "right" for the rest of your life, but until you yield they just won't buy from you. Why? Because they can.

Cheers,
Ronen.
 
L

larsahl

#9
1. Are IEC standards harmonized? Manufacturer = Yes, Client = No
2. Can the Low Voltage Directive and ATEX directive both be listed on a DoC.


1. First comes the IEC standard then it is adopted into an EN standard.
Most of the EN standards are an copy of the IEC standard. I've read that about ~79% of the EN standards is an IEC. When you are doing an DoC you can write IEC/EN if the product fulfils both standards should be enough?.
2. Yes I think so, but if your product is going under Machinery directive you should write that instead of LVD as CharlieUK mentioned before.
 

CharlieUK

Quite Involved in Discussions
#10
1. Are IEC standards harmonized? Manufacturer = Yes, Client = No

No.
Only EN standards currently listed in the Official Journal of EU are "Harmonised Standards". Lists for various directives available at: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm
IEC standards are often developed in conjunction with CENELEC standards, any may be identical in content with an "EN wrapper". but only EN standards are Harmonised.
You are not required to apply EN standards, but as only Harmonised Standards offer a presumption of conformity you would be advised to apply EN standards.
Harmonised EN standards are also developed by other organisations, such as ETSI.

2. Can the Low Voltage Directive and ATEX directive both be listed on a DoC.
Certainly.
I would also expect such a product to also fall under EMC Directive, so that can (should) be listed on same DoC.
 
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