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10 CLUES ABOUT CE 3Rd Parties Don’T Want You to Know 10 CLUES ABOUT CE 3rd Parties Don’t 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 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. Cut The 3rd Party From CE Certification Alura Group Anna Paulownastraat 32 2518 BE, The Hague, Netherlands T +31703624896 F +31 70 7568026 http://www.cemarking.net Contents 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!.................................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!.................................................................23 Han Zuyderwijk!................................................................................................................24 Feedback!...................................................................................................................24 © Han Zuyderwijk | 10 Clues About CE 3rd Parties Donʼt Want You To Know" 3 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 Clue #1 Certification vs. ‘Self-certification’ What most people don’t realize when they start their first CE Marking project (and what is important 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. 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 non- compliant 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 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 Clue #2 Third Party Certification Bodies As mentioned, in some cases the CE Marking regulations do not allow self- certification, 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 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"
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