10 - Clues CE

10 CLUES ABOUT CE
3rd Parties Dont Want You To Know

But That Help You Find Your Way Out Of The CE Marking Maze
Han Zuyderwijk
10 Clues About CE
2010 by Han Zuyderwijk. All rights reserved. Published by Alura Group BV. No part of this publication may be reproduced or distributed in any form or by any means, or stored in ad database or retrieval system without the prior written permission of Alura Group BV. The author and publisher have used their best efforts in preparing this
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Alura Group
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Contents
A Message From The Author ..........................................................................................4 Certication vs. Self-certication ................................................................................5 Third Party Certication Bodies .....................................................................................7 Certication Trap .......................................................................................................7 Location of Certication Body ..........................................................................................9 Prepare for Conformity Assessment, Testing, and Certication .................................11 Standards .........................................................................................................................13 The Application of Standards is Voluntary ....................................................................15 Role of Vendors and Distributors ...................................................................................16 Internal/Company Organization .....................................................................................18 Technical File ...................................................................................................................19 Make Money with CE Marking ........................................................................................21 CEMarking.Net Sequential Training System .................................................................22 Han Zuyderwijk ................................................................................................................23 Feedback ...................................................................................................................23
Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!
A Message From The Author

I am about to disclose ten secrets of CE Marking that everybody should know before starting the CE certication of their product; ten facts that certication bodies and consulting rms do not want you to learn about. I will be criticized for what I tell you, but you will intuitively know that what I say is true. What you are about to hear will help you to take control of your product certication projects and help you back into the drivers seat, even without having to take driving instructions from certication bodies, distributors or authorities. You will learn about some of the pitfalls, so you will be able to avoid them. And I will tell you about the certication trap. If you have been struggling with the CE requirements and certication, then pay attention. Knowing these powerful secrets will allow you to be more effective in CE certication and to save a substantial amount of money in the process.
Han Zuyderwijk
Clue #1
Certication vs. Self-certication
What most people dont realize when they start their rst CE Marking project (and what is important to know), is that CE Marking is not a traditional form of product certication. I consider a traditional form of certication to be when you take your product to an institute for testing and certication, and basically wait for them to come back with the results of the approval. The certication body tells you which requirements apply and how the tests will be conducted. CE certication can be approached in the same way, if you choose. However, the CE Marking regulations give a manufacturer much more control and exibility. And I recommend you to take advantage of this exibility, because with a little more effort, your company can save a substantial amount of money.
How is CE Marking different? Well, in close to 90% of the cases, the European CE Marking regulations allow manufacturers to fully or partially self-certify their products. In other words, you are not required to have your product certied by a third party, but you can assess the product conformity yourself (or have it done on your behalf). This may seem a little strange, as you may think that manufacturers are tempted not to bother about product compliance at all. But the interesting thing is that the opposite is actually true. The European authorities hold the manufacturer (or importer) fully responsible for ensuring compliance before and after the product is placed on the market. If the inspection authorities nd noncompliant products in the market, they not only can prosecute the manufacturer or importer, but they may also order product withdrawal or recall, as well as the prohibition of sales. This has proven to be an important incentive for producers to take responsibility for their products compliance.
Surely self-certication gives you more control over your product certication project, and also more exibility to choose a conformity assessment method, because you are not longer conned to one particular test and one particular certication body.
This brings us to clue #2.
Clue #2
Third Party Certication Bodies
As mentioned, in some cases the CE Marking regulations do not allow selfcertication, or only allow it in part, and you are required to involve a third-party certication body in the conformity assessment of the product or production process. If this applies to you, then pay attention to the following: You should realize that you have the freedom to choose which certication body you would like to use. So, in this regard CE certication is not like UL certication, which only allows you to go to one organization. The CE Marking regulations give you the freedom to shop around, comparing prices and services. From my experience assisting clients with test and certication projects I can tell you that it is absolutely worthwhile shopping around. I have had cases where clients were able to save more than 50% of the highest bidders quoted price, just by getting proposals from several service providers.
Certication Trap It is important to note that once you made a choice for a third-party certication body, and you have sent them your application, you are no longer allowed to switch to another third party for that particular product. This is due to the rule that a certication body may not accept your application if you have made an application with a different certication body. So, once you have made your choice for a certication body, you are stuck with them. For a new product, you could nd another certication body. However, this new certication body will need to do their own audits of the production facilities, and probably also require the use of their own trusted laboratories. So, if you switch your certication body for the next product you need to have CE certied, you are probably going to be required to have a re-assessment of the product and a
second audit of the production facilities! In other words, when you do not select your certication body carefully, it either will cost you a lot of money and effort to switch to another, or you will just have to decide to live with it and stay with the rst one, although the other body has more reasonable conditions. This is what I call the certication trap. I cannot stress enough that if you are required to involve a certication body in the CE certication, it is essential that you take the time to prepare carefully and that you know how to choose a certication body.
Clue #3
Location of Certication Body
Only bodies that are located in one of the Member States of the European Economic Area (= European Union + Norway + Iceland + Liechtenstein) can become recognized third-party certication bodies for CE Marking. So, if you are located in North America or Asia, and a local company claims they are a Notied Body for CE, it most likely means that they are a subsidiary or sales ofce of a European certication body. The real certication activities are performed and concluded in Europe. Interesting, right? Therefore, why should you conne your search for CE Marking certication bodies or service providing companies to your region only, if the most important activities are going to be executed in Europe anyway?
Compliance testing is a different story altogether. Test laboratories can be located anywhere. As long as they have the expertise and the facilities to perform the required compliance tests according to European harmonized standards, you may use them. How do you check if they have the required competences and facilities? The answer is by checking that their accreditation covers the relevant European harmonized standards that apply to your products.
Please note: As I am writing this, there is not yet a formal requirement in the CE regulations regarding accreditation for test laboratories. However, this may change soon when a revision of the CE Marking system is adopted by the European legislators. As such, I recommend you work only with accredited test laboratories, especially when the laboratory is located outside of Europe. The reason for this is that the test reports and certicates of accredited laboratories are considered
more reliable and are better accepted by European customers and authorities. Look for laboratories that have accreditation that is also accepted or conrmed by a European accreditation body. You may think you will save money by contracting a test laboratory that offers testing for low prices, but if your European customers or the market surveillance authorities do not accept their test results, you may be left with nothing more than re-testing, and end up paying twice as much for the same test.
Please note: If you must involve a third-party certication body, it may have specic conditions about the test laboratory you use for compliance testing.
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Clue #4
Prepare for Conformity Assessment, Testing, and Certication
The lab manager of an EMC and electrical safety laboratory I frequently visit for my clients test projects recently told me something that shocked me: Almost 80% of the products offered for compliance testing fails the rst compliance test. Even more shocking: In most cases, the non-conformities can be prevented if the manufacturer is better prepared for the compliance testing. Can you imagine? So many companies waste money on a rst compliance test, which they arent likely pass because they did not prepare their samples, or they failed to provide the right documentation.
You will dramatically increase the chances of your products passing compliance tests if you are informed about the requirements as well as about the ways the laboratory will conduct the compliance tests. If you understand the requirements and the test to be performed, you can prepare the test sample properly.
Almost without exception, test laboratories conduct compliance tests according to the specications of standards. If you nd out which standards will be applied (you may simply ask the lab to tell you), you may obtain a copy of the standards and study them. In some cases it is even possible to simulate the tests in-house. Either way, it will allow you to verify whether your product is ready to pass the tests that test laboratories or certication bodies are going to conduct.
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In general, the CE Marking Directives text describes what documentation, information, and warnings are needed on the product label, and what markings are required. These requirements are an integral part of the CE approval process. Therefore, make sure you have the documentation available, and that the product label meets the specications. Your product cannot be approved without having the correct documentation in the correct form.
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Clue #5
Standards
As I have indicated above, standards are often applied for conformity assessment. The CE Marking regulations have a very particular relationship with standards: if your product meets the relevant specications of all appropriate European harmonized standards, it is automatically presumed to comply with the appropriate CE regulations. In other words, if your product is tested and approved according the European harmonized standards, it can be afxed with the CE Marking, because the product is presumed to comply with the CE Marking regulations. This is why standards provide an easy way to check CE compliance.
Please note: This presumption of conformity is accepted only for European harmonized standards, and even then only in the case where all relevant specications of all relevant European harmonized standards have been applied. The CE Marking cannot be afxed on the basis of compliance with UL or CSA standards. European standards are recognizable by the abbreviation EN in their reference code (e.g. BS-EN 60204-1). European standards are only considered European harmonized standards if the European legislator published its reference number on a list.
For each CE Marking regulation, a list of European harmonized standards is published. Standards are often updated in order to reect the latest state-of-theart technology. On average, every ve years a new version of the standard is adopted and published. For this reason, the lists of European harmonized standards also are updated often. Therefore, it is important that you regularly check the list of European harmonized standards, whether or not the European harmonized standards that have been applied for your products CE approval are still valid, or the presumption of conformity has been repealed in favor of a new version of that standard.
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The term harmonized in European harmonized standard does not refer to harmonization between international standards. It refers to the fact that the content of the standard is presumed to be harmonized with all or parts of the essential requirements of the Directive to which the standard pertains. However, many European standards are actually harmonized with international standards. For example, most European standards for electrical products are harmonized with the standards of the International Electrotechnical Committee (IEC). Additionally, an increasing number of ISO standards also are adopted as European harmonized standards.
If your product complies with the requirements of an (inter)national standard that is harmonized with a European harmonized standard, you will already know whether it will comply with the European harmonized standard. For example, one of my clients applied the Australian standard AS 10535-2002 Hoists for the transfer of disabled persons Requirements and test methods. This standard is harmonized with the equivalent European harmonized standard, EN 10535:1998. As such, my client knew that his product would meet the EN standard as well, and subsequently, that the presumption of conformity would be valid and the CE Marking could be afxed. The only challenge that remained was to include in the Technical File a conformity assessment report or test report referring to the EN standard instead of the Australian standard, because the CE Marking only can be afxed on the basis of a European harmonized standard.
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Clue #6
The Application of Standards is Voluntary
You should understand the difference between standards and CE regulations (which are called directives). Standards are voluntary. Despite what the name implies, directives are obligatory. In other words, the essential requirements of the directives are the law. Standards are merely a reference.
In other words, if your product fails to meet the standards, that does not mean the product cannot be CE approved. Although it is better if you can show compliance with the standards because you would be referring to a well-accepted industry practice, deviations from the standards are possible. As long as you can prove that the design solution you have chosen is safe, and that it ts within the safety framework set by the essential requirements of the appropriate CE Marking directive, you are perfectly ok.
Please Note: Some CE Marking directives may require you to involve a third-party certication body in the case you are deviating from a European harmonized standard. In the EMC Directive, which sets requirements for electromagnetic interference of products containing electronics and active components, standards are, though not in theory, in fact, obligatory. This is because the test parameters and limits are specied in the EMC standards. And because electromagnetic interference is invisible, there is basically no other way of proving compliance than by testing according to the EMC standards. However, in CE Marking this is an exception, and for most directives it is possible to deviate from the provisions of the standards.
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Clue #7
Role of Vendors and Distributors
Both vendors and distributors play an important role in product compliance. For example, components and parts may require CE Marking of their own, or may have a decisive inuence on your products compliance. I can illustrate this with a story: One of my clients manufactures and sells electrical well-being products. These are powered by power adapters, which are purchased from China. For the purpose of the electrical safety tests and the electromagnetic compatibility tests, the power adapter is considered an integral part of the test sample. The EMC test results showed that the sample failed the tests. When we investigated what caused the problem, it turned out that the power adapter was not CE compliant. In other words, the product could not be CE approved and had to be re-tested because a vendor supplied non-compliant part. A power adapter is a product that is required to be CE approved. And while the adapter in this story did in fact carry a CE Mark, the tests showed that the CE Mark was not afxed legitimately. Be aware that even if a part or component has the CE Marking afxed to it, you have no way of making sure that it is CE approved unless you have a test certicate or test report from an accredited laboratory.
At the other end of the spectrum, compliance problems may be introduced by distributors or retailers. Another example comes to mind, where a manufacturer of highly sensitive electronic devices was refused approval by their certication body due to the fact that an external warehousing company, which handled part of their warehousing and shipping needs, was not able to provide the documented evidence that they controlled the storing conditions. This meant that they could
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not ensure that the units arrived to the warehouse fully CE compliant. But, because quality control was not complete, it was not possible to ensure the quality of the products stored in the warehouse. The only options left were to replace the quality control by performing a random type test, which would raise the costs of CE certication drastically, or to help the warehouse get their storage control and quality procedures in order.
The vendors and distributors may also contribute to cutting the costs of CE certication. Some products are assembled exclusively from CE Marked components purchased from vendors. In such cases, the EMC Directive does not require you to test the whole assembly again. And for the Machinery Directive, you would not have to investigate the parts and components again, but you may focus on the areas where parts and components are integrated with the machine. Or, take the example of a machine, for which the control panel is supplied by a vendor. If the vendor takes care of the CE compliance of the control panel, the manufacturer of the machine does not have to assess the conformity again, on the condition that the manufacturer can show the documents that prove compliance of the control panel (e.g. Declaration of Conformity, certicate, Technical File). You can imagine that this saves the manufacturer a very substantial amount of money.
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Clue #8
Internal/Company Organization
From an organizational point of view, there are many aspects to CE Marking. It covers activities like regulatory affairs, technical design, and technical documentation, but also quality assurance, production, distribution, sales and marketing, and of course the management.
Sales and marketing persons often get to deal with CE Marking rst because customers are asking for it. The technical design department is very much involved, because they have to ensure that the product design meets the requirements of the Directives and standards. They also should ensure the drawings, schematics, wiring diagrams and other technical specications are made available for the Technical File. The persons responsible for the documentation and artwork must take care of the labeling requirements and requirements regarding marking and users information to be provided. CE certication is very much related to quality assurance as well, and so the quality assurance manager should be involved.
Therefore, it is clear that every one of these persons/departments should know about CE, but it is difcult to say who in the company should be in charge of CE Marking projects. What we often see is only one person in the company deals with all CE Marking issues. In my opinion, that is an almost impossible task. It is more efcient and more effective to set up a project team consisting of the different persons/departments I mentioned before. Relevant information can be shared, and tasks can be delegated. And, generally sharing the tasks in a project team leads to a CE approval much faster.
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Clue #9
Technical File
The Technical File is one of the most underestimated elements of CE Marking certication. A lot of companies focus on product compliance testing and assume that the Technical File is not very important. However, at the heart of the CE Marking system lays documented product compliance, which refers to compliance that is demonstrated by documentation. A Technical File is a collection of information and documentation that should prove the products conformity with the CE requirements. It should contain, at the very least, information about the design, manufacture and operation of the product.
In general, the Technical File must be kept for at least ten years from the last date of manufacture of a product (for medical devices, the period currently is ve years). Most CE Marking Directives require that the Technical File be kept in Europe. This means that non-European manufacturers must send the Technical File to someone in Europe. The recipient may be the distributor, but not all manufacturers want to share their trade secrets with distributors. One possible solution is to appoint an independent Authorized Representative who keeps the Technical Files on behalf of the manufacturer. The Authorized Representative handles the communication about the product compliance with the authorities on your behalf, and not with the distributor.
Please note: The information in the Technical File is intended for the European market surveillance authorities. They may request access to the Technical File at any time, and you will be required to provide the requested information within a few days.
The information in the Technical File should be in one of the ofcial languages of the European Union, or at least provide a translation. This means that drawings, diagrams, test reports, and certicates should be written in one of these
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languages as well. It is probably best to provide all compliance information in English, and to make it a procedure in your company to have documents available in English or at least with an English translation, should this not be your native language.
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Clue #10
Make Money with CE Marking
Do you know how difcult it is to nd CE approved products? Companies in Europe need to identify what products are CE approved, particularly if they are manufactured outside of Europe, because according to the law, when the products are imported the importing company becomes responsible for the CE Marking and liable for the product safety. Or, because a European company may save time and money in their own CE certication process if they use parts or components that already are CE approved.
For these European companies, it is a blessing if they (nally) meet manufacturers who know the CE Marking requirements, and who have taken responsibility and taken care of all the aspects of CE Marking (testing, Technical File, users manuals, product labeling, etc.). Not only will they place trust in you and your products, but they also will appreciate doing business with you because they do not have to put a great deal of effort in CE compliance issues.
For this reason, I recommend you advertise your products CE compliance. I am sure it will pay off. Do not forget to specify which European harmonized standards your products meet. This information is often forgotten. I have seen many cases in which the CE logo doesnt mean anything if you do not know which standards have been applied. Only then can companies appreciate the value of a products CE compliance.
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CEMarking.Net Sequential Training System

If you have bought a product from CEMarking.Net or have read a free report, youll be keen to learn if there are more goodies in the CEMarking.Net collection. Sure there are! Not only are there more training courses, but heres a little helping hand guiding you along the sequence you need to follow to get the maximum advantage. On this page, youll nd the sequence that has worked best for most clients. Step One: 10 Clues 3rd Parties Dont Want You to Know If you want to stop wasting money on CE certication and dramatically increase your CE marking approval success rate this book is a must read. Everyone should read this book before starting their rst CE marking project. It helps you to understand CE certication, so you dont depend on certication bodies any longer. Readers have been able to cut their CE costs by 50% and more on the basis of the 10 clues.
Step Two: The Ultimate CE Marking Guide If you need results fast and don't know where to go next, this is the product you want to get. It's the world's easiest and most practical CE marking self-certication guide. Heck! It's the only CE self-certication guide! It's CE marking made simple: We have it all laid out for you. Just follow the steps and you can't go wrong.We tell you what is important, give you the templates and checklists to ll out. The Ultimate CE Marking Guide is a home study course and coaching program that navigates you through each of the steps of the CE marking in an efcient way. You are also provided with the templates and checklists that are necessary to document your conformity assessments, as well as to compile the obligatory Technical File.If you can ll out forms, and follow instructions, you can do the CE self-certication successfully with this on-line course and coaching program. You will be certain you did it right: The course comes with extensive help in Forums, as well as with a total of three hours of consulting. You also receive coupons for having us check the compliance documents you made with help of our course. Visit http://www.cemarking.net/the-ultimate-ce-markingself-certication-system/ Step Three: Personal, Email or Phone Consulting Do you need more personal assistance? Visit http:// www.cemarking.net/services. for the options.
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Resources
Han Zuyderwijk
It all started in 1995, when Han left the University of Leyden with a Degree in International and European Law, and started to work as an assistant account manager for a small CE marking consulting rm. Soon after establishing his own company in 1998, Han became a trusted key expert chosen in many European Union projects assisting with transposition and implementation of European technical regulations. In this capacity he helped writing laws and technical regulations related to CE marking, certication, standardization, accreditation and metrology in countries like Russia, Turkey, Lebanon, Croatia, Bulgaria, Bosnia and Herzegovina, Marocco, Moldova and Albania. Today, Han is an author, speaker and consultant based in the Netherlands. His company, Alura Group, develops CE certication self-help systems for small and medium sized companies that export technical products to Europe. His clients seek his counsel on optimizing CE certication processes. This extends to regulatory issues, quality management and product liability. Hans articles have been published in over a dozen magazines and trade journals. His communicational skills have resulted in many invitations as a guest speaker and lecturer at events in the United States, China, Russia and most European countries Feedback If you have feedback or any questions please email or call Alura Group. No matter is too small. Email: han@cemarking.net.
To view all products visit http://www.cemarking.net/products
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If you nd anything that bugs you, please click here to send me an email. Nothing is too small or too big. And if I can, Ill be sure to x it. han@cemarking.net
Alura Group
Sweelinckplein 9-11 2517 GK, The Hague, Netherlands T +31703624896 T (941) 312-7780 http://www.cemarking.net

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10 CLUES ABOUT CE

3rd Parties Dont Want You To Know

A Message From The Author

This brings us to clue #2.

CEMarking.Net Sequential Training System

To view all products visit http://www.cemarking.net/products

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