Hi Jeff, Regarding your questions.
1. Notified bodies would only be connected to the concept CE marking "approval" in cases where the a Notified Body is mandated--for example, Medical, Telecom, some Personal Protective Equipment, etc. Even here, the idea is not so much an approval as an affirmation of the manufacturer's claims and the subsequent issuing of a CE marking associated with a Notified Body number. Where any certification body or (certification body acting in its capacity as a notified body) issues a certificate (here meaning a standard document relating to parameters affirmed--usually a standard--and requiring a follow up inspection--usually ISO 9000 or a factory inspection), the notified body is backing all of the products covered by the certificate. While a serial number may exist for the specific model tested, the certificate normally covers a range such as a model or model family. Hence, certification bodies who issue marks are exposed to the liability associated with the product relative to the certified parameters. This is why they carry very large insurance policies. This is also the very nature of certification. It is easy to get confused because there are many things that are sometimes called certification that are really a legal version of it and other things that look like certification but really stop at the test stage--like a Competent Body certificate of conformity under the EMC Directive. Here again, there might be a product range (so its an oddball again), but if the products made by the manufacturer do not match the one that was tested, the Competent Body has no involvement. In the case of certification, the certification body would be quite exposed because its mark indicates that all products made by the manufacturer meet the originally stipulated parameters. Indeed, it does go without saying that the manufacturer still signs a declaration of conformity. Manufacturers are never out of the liability loop. They are only more or less exposed. With certification, their exposure declines. With due diligence, certification, and solid engineering their exposure in minimized. (Throw in 'right marketing.') Without certification, exposure increases. 2. Certification for a TUV mark or a GS mark requires safety critical components to be certified. This often makes good common sense and fills the vacumn created by the question, "How do I assure the component I use will work for my needs?" The CE marking was never intended to answer this question. It answers the question, "How do I know this product meets the minimum essential requirements?" Glad to see discussions of this kind growing. Gene Panger TUV Product Service ------------- Original Text >From [email protected] (Compliance West), on 02-5-96 5:54 PM: To: <[email protected]> Gene and Vic, Thanks for letting everyone know about notified body certification. A couple of points that I think are important: 1. If a notified body is contacted for CE marking approval, notified bodies will judge ONE serial number for compliance. There is nothing stating that the notified body is taking any responsibility for any PRODUCTION units. Also, it goes without saying that the mfr still signs the DofC in this case. 2. I further understand that it is not possible to obtain a GS Mark if any safety critical item has a CE marking only. The safety critical items have to have safety markings in kind. Jeff Lind Compliance West >Vic, > >Great observation and the simple answer is, under self-declaration only, >there isn't much more for protection. And you are right, the people you >deal with will not think like you. It is still possible to add >certification on top of your self-declaration. When anyone asks, "Why would >I do that?" your questions points to one reason. > >I realize this mail may seem like an advertisement for all certification >bodies but the plain fact is, the service of certification and the needs >that drive it, are still present in a self-declaration environment. It's >just a question of whether you want to add volunatry certification or not. > >Gene Panger >TUV Product Service >------------- >Original Text >From "Victor L. Boersma" <[email protected]>, on 27-4-96 8:14 PM: >To: "EMC-PSTC" <[email protected]> > >In the grey past, we obtained certification/listing from our >friendly certification houses. If we thought that something >was wrong with the application of an old standard to a new product, >we would have a heart-to-heart talk with our certification >organization. If we had a good, solid and valid argument, chances >were that our certification organization would agree and certify us >to the spirit of the standard. In addition, it was likely that our >certification organization would propose changes to the standard, to >rectify the anomaly. > >In the brave new world of "Declaration of Conformity", the only >time you have to explain yourself is, when you get caught. > >The question will be whether the regulatory police will consist of >intelligent people who think like you, or will they be dummies who >think unlike you ? > >If they think unlike you, your organization may be in for >extraordinarily expensive times, where the fact that they don't >have you on the payroll any longer, will not offset the costs. > >Question: > >How are we going to best protect our owners and ourselves in this new >environment ???? > > >Ciao, > > >Vic Boersma > > The following was included as an attachement. Please use UUDECODE to retrieve it. 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