10_Clues CE

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<p>10 CLUES ABOUT CE3rd Parties Dont Want You To KnowBut That Help You Find Your Way Out Of The CE Marking Maze</p> <p>Han Zuyderwijk</p> <p>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</p> <p>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 les contained in this book or in any accompanying media les such as CDs or DVD, and specically disclaim, without limitation, any implied warranties of merchantability and tness for a particular purpose, with respect to program listings in the book, the techniques described in the book, and/or the use of les. In no event shall the author or publisher be responsible or liable for loss of prot, 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 les, instruction, audio or video connected with this information.</p> <p>Further, the author and publisher have used their best efforts to proof</p> <p>and conrm the content of the les, but you should proof and conrm 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.</p> <p>Alura GroupSweelinckplein 9-11 2517 GK, The Hague, Netherlands T +31703624896 T (941) 312-7780 http://www.cemarking.net</p> <p>ContentsA 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</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>3</p> <p>A Message From The AuthorI 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.</p> <p>Han Zuyderwijk</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>4</p> <p>Clue #1Certication vs. Self-certicationWhat 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.</p> <p>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.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>5</p> <p>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.</p> <p>This brings us to clue #2.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>6</p> <p>Clue #2Third Party Certication BodiesAs 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.</p> <p>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</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>7</p> <p>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.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>8</p> <p>Clue #3Location of Certication BodyOnly 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?</p> <p>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.</p> <p>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</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>9</p> <p>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.</p> <p>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.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>10</p> <p>Clue #4Prepare for Conformity Assessment, Testing, and CerticationThe 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.</p> <p>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.</p> <p>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.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>11</p> <p>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.</p> <p> Han Zuyderwijk | 10 Clues About CE 3rd Parties Dont Want You To Know!</p> <p>12</p> <p>Clue #5StandardsAs 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.</p> <p>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...</p>