Safety/EMC

In addition to the CE marking affixed to a product, customers may demand a European third-party (notified body) approval mark, certification, or test report connoting a higher level of quality to ensure safety/EMC compliance. To control non-conforming products the following clause from the Official Journal of the European Communities (OJEC) applies ... 

Test reports are technical records on the conformity assessment of a product according to specific standards. Test reports are concise accounts, including clause-by-clause details on the results of the product safety/EMC assessment, standards rationale, test data, construction, and critical components. Test reports are an essential tool for conformity assessment. Test reports contain the technical results of the conformity assessment and need not contain confidential design information. Test reports may be requested by customers, testing/certification bodies, or enforcement authorities for review and verification purposes. 

Directives tell us why we must comply (consumer safety/EMC) and what may happen if we ignore the laws (withdraw products). But it s the European standards that show us how to comply (design and assessment). 

There are several ways for product and machine manufacturers to show compliance with the European directives. However, only one way presumes conformity— the use of harmonized European standards. This is why I strongly recommend the application of harmonized standards, also known as European Norms (ENs). Standards play an important role in European Union safety/EMC compliance for products and machines. Standards become valid in Europe after they are published in the Official Journal and are transposed into member states national standards. The ENs are listed or appended to the directives themselves. 

Quality assurance techniques (e.g.. ISO 9(X)0 factory quality), are not relevant for modules A, Aa, or B-C and may not take the place of the safety/EMC directives for product conformity. 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

Note. In all three cases, the CE marking, declaration, and technical file shall be in place. ISO 9000 factory quality techniques are not a part of modules A, Aa or B-C (see Product Quality versus Factory Quality in Chapter 5). The relevant safety/EMC directives and conformity assessment modules still apply. 

The technical file is for market surveillance purposes and must be kept at the disposal of national enforcement authorities. The documentation must be readily available to a duly substantiated request by enforcement authorities for inspection and control purposes. Failure to make the documentation available may constitute sufficient grounds for doubting the presumption of conformity. It is the manufacturers or their authorized representative in Europe who are ultimately responsible for the accuracy of the technical file. The technical files accuracy and the product safety/EMC conformity are of paramount importance. 

The technical file consists of the technical documentation necessary to demonstrate the conformity of the product to the essential requirements of the directives (LVD, EMC, Machinery, etc.)- It shall cover the design, manufacture, and operation of the product. The file may be in English or another EU language and should only address the safety/EMC issues, in other words, kept to a minimum. The contents of the file depend on the applicable directive, but in general consists of the following ... 

Notice This Declaration of Conformity is supported by the attached safety/EMC approval certifications, numbers S9512345 and V9554321 issued by TUV Rhein- ... 

An approval mark and certificate visibly demonstrate product quality (safety/ EMC) and can lay to rest any doubts the consumer may have concerning a product s conformity to the EU directives and standards. The requirement for certification can come from ... 

Due diligence means taking all reasonable steps to ensure conformity. With only a few exceptions, the manufacturer/importer is ultimately responsible for a product s compliance to directives, but with a mark, certificate, or test report from a notified body the suppliers risks are decreased and their defense of due diligence enhanced, should the products safety/EMC conformity come into question. It is the responsibility of notified bodies to accurately interpret directives and standards through testing and certification, thereby ensuring conformity and building consumer confidence. 

The approval mark on the product and accompanying test report from a notified body serve two purposes. In regards to safety/EMC conformity, the test report is the manufacturer s best line of defense if the product s safety is questioned, and a reputable approval mark on the product is marketing s best sales tool As the European Commissions Guidelines on the Application of Council Directive 73/23/EEC (LVD), states ... 

Within the European Conformity safety/EMC context, three types of quality assessments are addressed in terms of the entities they relate to ... 

The CE marking is not intended for marketing or sales and is not a quality marking of any kind. Confidence in a product s safety/EMC quality must be earned and verified through a system of independent checks and balances. 

Product safety/EMC claims of conformity, for sales and marketing, often raise more questions than they answer and may not be supportable. Unsubstantiated claims are in abundance Watch out for the following statements ... 

A consultant may be knowledgeable in one field, but carefully check out those who offer the so-called one-stop-shop for U.S. EU—Safety EMC. Many of these shops actually specialize in only one area (such as U.S. EMC/FCC) and have a much lower level of competence in other areas. 

Buyer beware. Equipment s Conformity in Question Some manufacturer s focus on the directives essential requirements as a way to get around the safety/EMC rules (standards). In these cases there is no presumption of conformity. ... 

Technical requirements and safety/EMC laws and standards exist to protect the consumer from dangerous occurrences caused by products. The German Equipment... 

Surveillance on the ground by authorities with support of safety/EMC experts... 

Evidence to date leaves the credibility of the CE marking in doubt. Based on my numerous safety/EMC inspections of equipment (> 75% fail) and seeing... 

You may be surprised and even discouraged at what first appears to be the work involved to achieve European Conformity for your products. At this point you can either fight it and continue to ask, Why me or simply apply the rules and accept them. Remember, for the most part the world is or soon will follow the European safety, EMC, quality, and environmental rules. It is sometimes difficult for us to change our ways of thinking, but once we learn and apply the principles to the design and manufacturing of the first product, achieving subsequent product conformity will be much easier—if not automatic. 

Standards. European harmonized standards provide specific technical safety/EMC design, testing and pass/fail rules for components, products, and machines. Standards are the cornerstone of the New Approach, and without them the Single Market could not function. The EU standards, referred to in the directives, provide a presumption of conformity for equipment manufactured in accordance with these standards. Without properly applying EU standards, equipment will not benefit from a presumption of conformity conferred by the use of such standards. 

Certificates and approval-marks. Visible attestations from European accredited testing and certification bodies that provide positive evidence of conformity. Approval marks are product quality marks for safety/EMC compliance. Certificates and marks are supported by verifiable and accurate test reports from EU-notified or competent bodies. Marks and certificates establish the independent verification of a product s conformity that customers may demand. Regular follow-up inspections are performed, on equipment with EU approval marks, by the certification body to ensure ongoing conformity. When issued by recognized European certification bodies, official certificates and test reports provide the ultimate defense of due diligence should a product s conformity come into question. 

A Test Report and Approval Mark from a highly reputable European testing and certification body builds consumer confidence in the equipment s safety, EMC, and quality. To adequately protect the consumer and manufacturer, this safety/EMC certification and approval marking philosophy should be applied to all equipment categories, including components, products, and machinery. Manufacturer s whose equipment truly meet the goals of European Conformity will pass the final test as marketable and approved ... 

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