Notified bodies testing

A notified body tests and certifies that a specimen provided by the manufacturer or his EU-resident authorized representative and this specimen representing the production complies with the requirements given in the directive. 

Notified bodies are listed in the Official Journal of the European Communities Member states should accept test reports and/or certificates of all notified bodies Testing may be subcontracted to other laboratories, under the direct supervision of the body and... 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

Different conformity assessment options are available, depending on the type of device and the level of associated risk. For lotv-risk devices, the manufacturer can make a declaration of conformity based solely on self-assessment, without the need for the involvement of a Notified Body. For all other devices Notified Bodies are required to perform one or more of the tasks outlined in Table 10.2. HIV and hepatitis tests and blood grouping tests represent the highest risk devices, as they are critical to ensuring the safety of blood and blood products. For example, a defective HIV test device could result in widespread infection in an unsuspecting population, whereas the detrimental effects ofan AIMD or a Class III device failure will just be confined to the individuals treated by the device. At this end of the risk spectrum. Notified Bodies are required to verify the applied quality system, the specific device design, and the... 

The purpose of all the conformity assessment procedures is to ensure that the device as designed and as subsequently manufactured will meet the essential requirements. For most devices where Notified Body involvement is required, the manufacturer may choose between the strategies of relying on the application of appropriate quality systems or independent testing to demonstrate this. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

For products in Classes Ila, lib and III, and AIMDs, examination and certification by a notified body of a specimen product (t)q)e examination Aimex III of the MDD) coupled with a varying degree (partially restricted by product class) of product or production quality assurance (MDD Annexes IV, V and VI), which ensures that the manufacturing process produces products that conform to the certified t)q)e and might involve a quality system for manufacture and final inspection (Annex V), or a quahty system for final inspection and testing (Annex VI). 

All devices other than those covered by Annex II are subject to the EC Declaration of Conformity procedure (Annex III), which does not involve the intervention of a notified body, but which includes supplementary requirements for devices for self-testing, which does involve a notified body (Annex III). 

Flow capacity testing The usually special testing of a pressure relief device to determine its operating characteristics, including measured relieving capacity. This tests whether the valve flows the capacity as stated in the literature or as per given flow coefficients, or to simply determine the flow coefficient of the valve as such. This is done on a spot-check basis by independent notified bodies in limited locations worldwide especially approved for that purpose. 

Actually it is good practice that any valve received from an off-site location should be bench tested to verify set pressure and leakage rate. However, please be aware that if the tag on a new valve is broken, the supplier forfeits on the warranty of the valve unless it is done by or in the presence of a notified body who is able to tag or lead the valve again. 

Apparatus approved by a notified body (certificate of conformity, control certificate) shall be marked by the manufacturer with an Ex in a hexagon according to Fig. 3.1(a). This mark ensures the compliance of the individual apparatus with the specimen tested by the notified body and ensures that all routine tests according to the relevant Harmonized European Norms (if a certificate of conformity has been issued) or all routine tests prescribed in the control certificate have been carried out and passed successfully. According to Directive 82/130/EEC, apparatus with a control certificate shall be marked with an additional S in a circle (see Fig. 3.1 (b)). 

These notified bodies have introduced a type of certificate without any legal status the component certificate, which is marked by a U following the certificate number. This document acts as a working instrument for a simpler handling of components like conductor bushings, terminal blocks or inspection windows. The notified body issuing such a component certificate herewith declares the conformity with the relevant Harmonized European Norm and the relevant type tests. Other notified bodies accept this document without asking for renewed type tests. In this way, components can be handled in a very efficient... 

Table 3.8 List of notified bodies in the European Union for type testing and certification of electrical equipment for potentially explosive atmospheres...

The notified body verifies the product s compliance with the technical documents and with standards, carries out the type tests according to these standards and issues the EC-type examination certificate. 

The manufacturer carries out the relevant routine tests and affixes the identification number of the notified body during the manufacturing process. This is under the responsibility of this notified body. 

For the purpose of supervision, the manufacturer grants the notified body access to all facilities for production, acceptance, testing and storage. In addition, he submits technical documents. 

The notified body carries out the relevant test by controlling and inspections applied to each item to ensure the product s compliance with the relevant requirements given in the directive. 

If the apparatus has been type tested and certified (certificate of conformity, control certificate) according to the old article 100 directives, the identification mark of the notified body and the certificate number shall be affixed on the apparatus. In the same way, a component (with a component certificate) shall be marked. 

By no means will this chapter claim to fill a standard s place. Therefore, a very careful reading of standards is recommended and in case of any need for clarification the testing houses or notified bodies should be asked for interpretation. 

Primary and secondary cells (accumulators) are in the scope of the m-standards. Only cells, which in normal use (under the specified conditions given by their manufacturer) are not expected to release gas, do not release electrolyte or produce excessive temperature rise, may be encapsulated. The m-apparatus shall be so constructed as to allow a venting to the outside atmosphere of any gas which may be generated, or precautions shall be taken to avoid gas release or cell deformation adversely affecting the type of protection m. These precautions should be based upon an agreement between the testing house or the notified body and the manufacturer. 

Involvement of the test institutes and notifies bodies for compliance assessment. 

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 ... 

Accreditation bodies are independent national accreditors who evaluate testing and certification parties according to recognized norms. After a third party is found competent in a member state, such as in Germany, the accreditation body then notifies the European Commission who notifies the other member states by listing them in the Official Journal. These third-party testing and/or certification bodies are then considered EU-accredited third parties or notified bodies. 

Notified bodies are independent testing laboratories and/or certification bodies recognized in the European Union to perform tests and issue reports and certificates on conformity. These bodies are generally referred to as notified bodies. Depending on the directive an accredited body may be referred to as a notified body, competent body, certification body, third party, or other (see Notified Bodies and Third Parties in Chapter 4). Test reports and certificates issued by accredited bodies attest to a product s or system s conformity to the relevant standards. These reports and certificates are the basis for mutual recognition of test results and build consumer confidence in a product s conformity. 

Some people believe that the reason for the popularity of German safety approvals such as the GS Mark, is that approvals were mandatory in Germany. After all, over 100,000 different products bear the GS Mark (GS = Safety Tested). Approvals and marks have, however, never been mandatory by German law for the vast majority of products and machines. Their popularity is driven by expectations in the marketplace from the product users, consumer groups, insurers, and employers. These high expectations continue today in Germany and some other countries. (See chapters on Notified Bodies and Certification [Chapter 4] and the Quality and Safety Mindset [Chapter 5].)... 

Voluntary certification. Oftentimes manufacturers have products assessed by a European body (notified or competent) for a mark and certification for marketing purposes and as a defense of due diligence in the event of a challenge. The intervention of notified body certification route provides confirmation of accuracy of the testing and documentation (test reports, etc.). 

Mandatory certification. Most products and machines do not require mandatory certification. But in such cases, as with some high-risk machinery or when harmonized standards do not exist or are not applied in full, a type examination by a notified body is required. After successful testing, a Type-Exam Certificate for machinery or Certificate of Conformity for EMC is issued by the EU Body. The manufacturer then affixes the CE marking and issues a declaration of conformity. 

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 assessment, standards rationale, test data, construction, and components. Test reports are an essential tool for conformity assessment and the most important element of the technical file. The manufacturer may obtain a test report as a element of proof of conformity from an notilied/compe-tent body (not mandatory) in advance and keep it with the technical file. The availability of such a report [from a notified body] would make matters easier and speedier in the event of challenge by authorities (refer to Notified Bodies and Due Diligence sections in Chapter 4). 

In the last two cases it is advisable (and sometimes mandatory) to consult a notified body for guidance and testing. Authorities are obliged to recognize that products manufactured in conformity with harmonized standards are presumed to conform to the essential requirements of the directives. 

Notification is the formal recognition of a testing and/or certification body by the European Commission. After a successful laboratory assessment and recognition by an accreditor, the state government notifies the Commission of the nationally accredited body. The accredited bodies are then listed in the OJEC as Bodies Notified to the Commission and to the Member States, commonly referred to as notified bodies or third parties. 

Market surveillance of products whether at the marketing and distribution stage or at the marketplace is the responsibility of the public authorities. In some member states, the notified bodies and the surveillance authorities come under the same authority, and lines of responsibility are organized to ensure that the two activities are separate and independent. Market surveillance may be performed at the national, regional, or local level, including the customs authorities. When a product s conformity is in doubt the authorities may resort to testing the product themselves at either their own testing facility or at those of a notified body. If they are... 

European notified bodies (safety) and competent bodies (EMC) are accredited at the national level by the member states, such as in Germany at the European level accreditation occurs when notified to the Commission and listed in the Official Journal of the European Communities. These accredited bodies are sanctioned by the European Commission and the member states to interpret directives and standards, and issue test reports and certificates on conformity. When a product becomes suspect or an incident occurs, the national enforcement authority may consider a test report or certificate issued by a European body. Having the notified body mark, certificate, and test report usually shifts the onus of proof in the manufacturer s favor, since the product was evaluated and certified by European recognized experts. 

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. 

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