10 CLUES ABOUT CE. 3rd Parties Don t Want You To Know. And That Help You Find Your Way Out Of The CE Marking Maze. Han Zuyderwijk

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1 10 CLUES ABOUT CE 3rd Parties Don t Want You To Know And That Help You Find Your Way Out Of The CE Marking Maze Han Zuyderwijk

2 10 Clues About CE 2013 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 book and the document contained herein. However, the author and publisher make no warranties of any kind, express or implied, with regard to the informational content, documentation, or files contained in this book or in any accompanying media files such as CDs or DVD, and specifically disclaim, without limitation, any implied warranties of merchantability and fitness for a particular purpose, with respect to program listings in the book, the techniques described in the book, and/or the use of files. In no event shall the author or publisher be responsible or liable for loss of profit, or any commercial damages, including, but not limited to, special incidental, consequential, or any other damages in connection with or arising out of furnishing, performance, or use of this book, program files, instruction, audio or video connected with this information. Further, the author and publisher have used their best efforts to proof and confirm the content of the files, but you should proof and confirm information such as dates, measurements, and any other content for yourself. The author and publisher make no warranties of any kind, express or implied, with regard to that content or its accuracy.

3 A Message From The Author... 4 Certification vs. Self-certification... 5 Third Party Certification Bodies... 7 Certification Trap... 7 Location of Certification Body... 9 Prepare for Conformity Assessment, Testing, and Certification Standards The Application of Standards is Voluntary Role of Vendors and Distributors Internal/Company Organization Technical File Make Money with CE Marking Han Zuyderwijk Feedback Contents Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 3

4 A Message From The Author I am about to disclose ten secrets of CE Marking that everybody should know before starting the CE certification of their product; ten facts that certification bodies and consulting firms 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 certification projects and help you back into the driver s seat, even without having to take driving instructions from certification 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 certification trap. If you have been struggling with the CE requirements and certification, then pay attention. Knowing these powerful secrets will allow you to be more effective in CE certification and to save a substantial amount of money in the process. Han Zuyderwijk Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 4

5 Certification vs. Self-certification What most people don t realize when they start their first CE Marking project, and what is essential to know, is that CE Marking is not a traditional form of product certification. I consider a traditional form of certification to be when you take your product to an institute for testing and certification, and basically wait for them to come back with the results of the approval. The certification body tells you which requirements apply and how the tests will be conducted. CE certification can be approached in the same way, if you choose. However, the CE Marking regulations give a manufacturer much more control and flexibility. And I recommend you to take advantage of this flexibility, because with a little more effort, your company can save a substantial amount of money. Clue #1 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 certified 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 find 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 product s compliance. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 5

6 Surely self-certification gives you more control over your product certification project, and also more flexibility to choose a conformity assessment method, because you are not longer confined to one particular test and one particular certification body. This brings us to clue #2. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 6

7 Clue #2 Third Party Certification Bodies As mentioned, in some cases the CE Marking regulations do not allow selfcertification, or only allow it in part, and you are required to involve a third-party certification 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 certification body you would like to use. So, in this regard CE certification is not like UL certification, 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 certification 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 bidder s quoted price, just by getting proposals from several service providers. Certification Trap It is important to note that once you made a choice for a third-party certification 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 certification body may not accept your application if you have made an application with a different certification body. So, once you have made your choice for a certification body, you are stuck with them. For a new product, you could find another certification body. However, this new certification 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 certification body for the next product you need to have CE certified, you are probably going to be required to have a re-assessment of the product and a Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 7

8 second audit of the production facilities! In other words, when you do not select your certification 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 first one, although the other body has more reasonable conditions. This is what I call the certification trap. I cannot stress enough that if you are required to involve a certification body in the CE certification, it is essential that you take the time to prepare carefully and that you know how to choose a certification body. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 8

9 Location of Certification 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 certification bodies for CE Marking. So, if you are located in North America or Asia, and a local company claims they are a Notified Body for CE, it most likely means that they are a subsidiary or sales office of a European certification body. The real certification activities are performed and concluded in Europe. Interesting, right? Therefore, why should you confine your search for CE Marking certification bodies or service providing companies to your region only, if the most important activities are going to be executed in Europe anyway? Clue #3 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 certificates of accredited laboratories are considered Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 9

10 more reliable and are better accepted by European customers and authorities. Look for laboratories that have accreditation that is also accepted or confirmed 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 certification body, it may have specific conditions about the test laboratory you use for compliance testing. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 10

11 Prepare for Conformity Assessment, Testing, and Certification 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 first 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 first compliance test, which they aren t likely pass because they did not prepare their samples, or they failed to provide the right documentation. Clue #4 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 specifications of standards. If you find 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 certification bodies are going to conduct. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 11

12 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 specifications. Your product cannot be approved without having the correct documentation in the correct form. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 12

13 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 specifications 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 affixed 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 specifications of all relevant European harmonized standards have been applied. The CE Marking cannot be affixed 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 ). 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 reflect the latest state-of-theart technology. On average, every five 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 product s CE approval are still valid, or the presumption of conformity has been repealed in favor of a new version of that standard. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 13

14 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 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 affixed. 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 affixed on the basis of a European harmonized standard. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 14

15 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. Clue #6 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 fits 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 certification 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 specified 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. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 15

16 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 influence on your product s 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 affixed legitimately. Be aware that even if a part or component has the CE Marking affixed to it, you have no way of making sure that it is CE approved unless you have a test certificate 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 certification 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 Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 16

17 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 certification 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 certification. 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, certificate, Technical File). You can imagine that this saves the manufacturer a very substantial amount of money. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 17

18 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 first 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 specifications 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 certification 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 difficult 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 efficient 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. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 18

19 Clue #9 Technical File The Technical File is one of the most underestimated elements of CE Marking certification. 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 product s 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 five 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 official languages of the European Union, or at least provide a translation. This means that drawings, diagrams, test reports, and certificates should be written in one of these Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 19

20 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. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 20

21 Clue #10 Make Money with CE Marking Do you know how difficult it is to find 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 certification process if they use parts or components that already are CE approved. For these European companies, it is a blessing if they (finally) 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 product s 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 doesn t mean anything if you do not know which standards have been applied. Only then can companies appreciate the value of a product s CE compliance. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 21

22 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 firm. 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, certification, 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 certification self-help systems for small and medium sized companies that export technical products to Europe. His clients seek his counsel on optimizing CE certification processes. This extends to regulatory issues, quality management and product liability. Han s 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 or call Alura Group. No matter is too small. han@aluragroup.com. Han Zuyderwijk 10 Clues About CE 3rd Parties Don t Want You To Know! 22

23 If you find anything that bugs you, please click here to send me an . Nothing is too small or too big. And if I can, I ll be sure to fix it. han@aluragroup.com!