Conformity assessment procedures for Radio & Telecommunication Terminal Equipment Scheme

Transcription

1 Conformity assessment procedures for Radio & Telecommunication Terminal Equipment Scheme RD_060, Issue 09 This guide describes the certification services of Telefication for manufacturers and importers to realise that their products can be placed on the European market. No rights may be derived from the text of this document. Copyright 2016, Telefication Telefication B.V. The Netherlands

2 for the R&TTE scheme Page 2 of 38 Revision record sheet NOTE: The person who initiated the document or modified the document is responsible for maintaining this record sheet (in case of use please remove revision information) Revision Section number Page numb er Date Remark(s) issued by Revision record sheet added KEB Change of document name KEB Modified paragraph About Telefication EB Modified paragraph Termination (expiration), EB reduction, suspension and withdrawal of Certificates Annex A control on EN and EN 45012; replaced EB by ISO/IEC resp. ISO/IEC , 4.2 & 4.3, 14, Update hyperlink for European harmonized EB 4.5 standards Annex E Changed Phone number EB Annex D Added RQ_160 EB Issued/modified by : Eric Bansberg Function : System Assessor Revision : 9 Date : Verified by : Willem Jan Jong Function : Manager Product Certification Date : Released by : Axel Gase Function : Quality Assurance Manager Date of release :

3 for the R&TTE scheme Page 3 of 38 Contents REVISION RECORD SHEET INTRODUCTION ABOUT TELEFICATION ABOUT THIS DOCUMENT THE R&TTE DIRECTIVE OVERVIEW OF THE SERVICES OF TELEFICATION FLOW DIAGRAM OF SERVICES THE INFORMATION SERVICES OF TELEFICATION R&TTE PACKAGE R&TTE PACKAGE DETERMINATION CATEGORY 1 OR COMPILATION OF TECHNICAL FILE NOTIFICATION THE CERTIFICATION SERVICES OF TELEFICATION COMPLIANT TO THE R&TTE CERTIFICATION OF QUALITY MANAGEMENT SYSTEMS WITH RESPECT TO PRODUCT COMPLIANCE ISO COMPLIANCE IN PRODUCTION SCHEME THE TEST SERVICES OF TELEFICATION SAFETY TESTING EMC TESTING RADIO TESTING ARTICLE 3.3 TESTING EMF (RF SAFETY) TESTING CREATION OF TECHNICAL CONSTRUCTION FILE (TCF) CONFORMITY ASSESSMENT PROCEDURES OF THE R&TTE DIRECTIVE OVERVIEW DIFFERENCES OF THE SEVERAL CONFORMITY ASSESSMENT PROCEDURES THE TELEFICATION APPROACH AND THE R&TTE DIRECTIVE NOTIFIED BODY SERVICES OF TELEFICATION APPLYING FOR AN OVERVIEW OF THE SPECIFIC RADIO TESTS (ANNEX III) INTRODUCTION ANNEX II (INTERNAL PRODUCTION CONTROL) ANNEX III (INTERNAL PRODUCTION CONTROL PLUS SPECIFIC TESTS) OVERVIEW OF THE SPECIFIC RADIO TESTS APPLYING FOR THE STATEMENT OF OPINION (ANNEX IV) ANNEX IV (TECHNICAL CONSTRUCTION FILE) TIME TO MARKET FLOW DIAGRAM Type-examination Statement of Opinion REGISTRATION PRODUCT VARIANTS THE STATEMENT OF OPINION APPLYING FOR APPROVAL OF QUALITY MANAGEMENT SYSTEM (ANNEX V) ANNEX V (FULL QUALITY ASSURANCE)... 25

4 for the R&TTE scheme Page 4 of ALTERNATIVES FULL QUALITY ASSURANCE [MODULE H] PRODUCTION QUALITY ASSURANCE [MODULE D] AND ACCREDITED TESTING APPROVAL OF QUALITY MANAGEMENT SYSTEM GENERAL REQUIREMENTS OF THE CONFORMITY ASSESSMENT PROCEDURES THE AFFIXING OF MARKINGS RECORD OF COMPLAINTS TERMINATION (EXPIRATION), REDUCTION, SUSPENSION AND WITHDRAWAL OF CERTIFICATES DRAWING UP A DECLARATION OF CONFORMITY DRAWING UP A DECLARATION OF RADIO TESTS PERFORMED MODIFICATIONS WITH RESPECT TO THE ASSESSMENTS TYPES OF MODIFICATIONS CHANGES TO THE DETAILS OF THE STATEMENT OR CERTIFICATE HOLDER CHANGE OF STATEMENT OR CERTIFICATE HOLDER ALTERATION/ADDITION OF A TYPE DESIGNATION AND OR TRADEMARK ADDITION OF NEW PRODUCT VARIANTS MODIFICATION OF PRODUCT HARDWARE/SOFTWARE MODIFICATIONS NOT EFFECTING THE REQUIREMENTS ANNEX A, ABBREVIATIONS AND PARAPHRASES ANNEX B, ESSENTIAL REQUIREMENTS ANNEX C, NOTIFICATION ANNEX D, FORMS AND DOCUMENTS ANNEX E, ADDITIONAL INFORMATION... 38

5 for the R&TTE scheme Page 5 of 38 1 Introduction 1.1 About Telefication Telefication is a third party test laboratory and third party certification body. The Dutch Council for Accreditation (Raad voor Accreditatie: RvA) has accredited Telefication to ISO/IEC (laboratory) and NEN-EN-ISO/IEC (product certification). More information about Telefication is available in RD_560, About Telefication. 1.2 About this document This document is a guide for manufacturers and importers, who want to apply for the services of Telefication in order to meet the requirements of the R&TTE Directive, when placing Telecommunication Terminal Equipment or Radio Equipment on the European market. This document describes the conformity assessment procedures of the R&TTE Directive that may be followed. The added value of the services of Telefication is given. When the assistance of a Notified Body is needed a description is given of the implementation of these services by Telefication. The Notified Body services are derived from the conformity assessment procedures as defined in the Annexes III, IV and V of the European R&TTE Directive 1999/5/EC. Furthermore this document gives information how to act when modifications to equipment are made. It also describes specific conditions, such as markings on the products, declarations to be drawn up, etc., which manufacturers and importers will have to deal with when using a conformity assessment procedure with or without the involvement of a Notified Body. 1.3 The R&TTE Directive The Directive came into force on 7 April The application of the Directive started in all the Member States of the European Union on the same day: 8 April There is one essential requirement in the R&TTE Directive, which is adding technical requirements compared to the situation before 8 April 2000, there is a risk of non-compliance. This essential requirement is defined in Article 3a: The protection of the health and safety of the user and other person, including the objectives with respect to safety requirements contained in Directive 73/23/EEC, but with no voltage limit applying. New are no voltage limit applying and the fact that safety is not limited to compliance with the LVD (Directive 73/23/EEC), but is defined on a higher level ( including the objectives of the LVD ). One of the consequences of this change is that aspects like the influence of electromagnetic radiation on the human body and the risk of an acoustic shock are now elements of the European compliance. The R&TTE Package is the service we supply to guide a manufacturer through all the obligations coming out of the R&TTE Directive. This service is also a good starting point for manufacturers, who want to approve their products to the R&TTE Directive. See chapter 2 for a description of The R&TTE Package. 1.4 Overview of the services of Telefication Telefication offers four groups of services: Information, Certification, Test and Notified Body services. The Information services of Telefication as far as related to the R&TTE Directive are: R&TTE package; Storage option on R&TTE Package;

6 for the R&TTE scheme Page 6 of 38 Determination category 1 or 2; Compilation of a Technical File Notification. The Test services of Telefication relevant for the R&TTE Directive are: Safety; EMF (RF Safety); EMC; Radio. The Certification services of Telefication relevant for the R&TTE Directive are: R&TTE Compliant (under development); ISO 9000; Compliance in Production. The Notified Body services of Telefication as defined by the R&TTE Directive are: Overview of the specific radio tests (Annex III R&TTE); Statement of Opinion (Annex IV R&TTE); Approval of Quality Management System (Annex V R&TTE). 1.5 Flow diagram of services See figure 1 on next page.

7 for the R&TTE scheme Page 7 of 38 Choosing Conformity Assessment Procedure(s) R Annex II Annex III Annex IV Annex V & T T E P A C Identification of radio tests Testing to (harmonized) standard(s) Declaration radio tests performed Creation of TCF Statement of Opinion Declaration of Conformity to radio test suites Approval of QMS K A G R&TTE Compliant Notification(s) Declaration of Conformity Determination of Category 1 or 2 E Marking, Packaging and Instruction Manual Compilation of Technical File + Storage of Technical Documentation Compliance in Production / ISO 9000 Internal Production Control Figure 1: Flow diagram of services Placing on the market

8 for the R&TTE scheme Page 8 of 38 Some clarification: Some activities are the direct responsibility of the manufacturer: they cannot be subcontracted or outsourced to third parties. In the flow diagram these activities are described with Italic letters and in red (Choosing Conformity Assessment Procedure, Declarations and Internal Production Control). The activities mentioned in gray boxes with blue letters have to be done by an R&TTE Notified Body, like Telefication. All the other activities can be fulfilled by the manufacturer or a third party. Telefication -as a third party- can supply services for all these activities, except Placing on the market. Testing can be performed by Telefication. In some cases (dependent of the availability or transportability of test equipment) the tests can also be performed on location. The Creation of a Technical Construction File is an activity of the manufacturer.

9 for the R&TTE scheme Page 9 of 38 2 The Information services of Telefication 2.1 R&TTE Package The R&TTE Package is a service to assist the manufacturer in his objective to meet the requirements coming out of the R&TTE Directive. This is done by means of supplying information to the manufacturer. The complete process is managed by Telefication and finally the manufacturer has to sign the documents (declarations) prepared by Telefication. Elements of the R&TTE Package are: List containing all related mandatory and voluntary standards; Marking/label; Additions to manual; Package instructions; Proposal on declarations (you only need to print this on your company paper!); Generation of Technical Documentation. The last step of the R&TTE Package is the Compilation of the Technical Documentation. The Storage of the Technical Documentation, Internal Production Control and voluntary certification of a Quality Management System are outside the scope of the R&TTE Package. Not included in the R&TTE Package are the costs involved with Testing, Notified Body activities, Determination Category 1 or 2, Notification(s), Creation of Technical Construction File and voluntary certification. 2.2 R&TTE Package + The R&TTE Package + consists of the R&TTE Package plus all the activities related to the obligation to store the Technical Documentation for a period of at least ten years after the last product is produced. The additional elements of the R&TTE Package + are: Storing of the Technical Documentation in the premises of Telefication (as long as required by the R&TTE Directive); Supplying information on changing regulations; Granting access to surveillance authorities; Delivering maintenance of the Technical Documentation in case of additions / modifications. The procedures of Telefication regarding the archiving of files, which are part of the accredited quality system of Telefication, are applicable for this storage of Technical Documentation. 2.3 Determination category 1 or 2 In the R&TTE Directive a distinction is made between the right to place a product on the European market and the right to use a product. The right to place a product on the European market is related to the essential requirements. When the essential requirements are met the product may be placed on the market. In some cases (see paragraph 2.4) a notification is needed and the manufacturer has to wait a period of four weeks before he can place the product on the market. But in general the right to place a product on the market is related to the essential requirements. The right to use a product is with this R&TTE Directive a different story. Some products may be used in the whole European Union. On the other hand there are products with restriction on its use. A restriction could be the need to obtain a license before it is allowed to use the product. These licenses could have all kind of conditions (like use of frequency bands, radiated output power and geographical areas). These restrictions on use can differ from country to country in

10 for the R&TTE scheme Page 10 of 38 Europe and even within a country. The most extreme situation is that the product never can be used in Europe (but it may be placed on the market when meeting the essential requirements). Products, which may be used all over Europe, are category 1 products. Products with restrictions on its use are category 2 products. An obligation to obtain a license before the product may be used, is not considered as a restriction in this context. Telefication has a service to determine whether a product is a category 1 or a category 2 product. Investigations are made in all of the 15 European countries, whether one or more restrictions exist on the use of the product concerned. For a category 2 product an Equipment Class Identifier is defined. This is called the Alert Symbol. Advice on the use of this Alert Symbol is included in the service of Telefication determining whether the product is category 1 or category 2 product. 2.4 Compilation of Technical File The compilation of a technical file consists of the following information: Technical documentation; - a general description of the product; - conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.; - descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product; - a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist (Article 5 of the R&TTE Directive 1999/5/EC); - results of design calculations made, examinations carried out, etc.; - test reports. Statement of Opinion; Declaration of Conformity; Category of product; Notification(s); Packaging information. 2.5 Notification If there are restrictions on the use of the product in other words it is a category 2 product- then notification could be needed before the product may be placed on the market. In the R&TTE Directive is stated you have to notify when the frequency used is not harmonized in Europe. Notification has to be done in every Member State, where you place the product on the market. This is the law so Member States are allowed to request such notifications. On the other hand in TCAM 3 a decision is made about this subject (decision 16 of that meeting). Decided is that notification is restricted to those Member States where the frequency used is not allowed in the national frequency allocation plan and only when you place the product on that market (see last sentence of the decision). This is no law but just a direction/interpretation. The law gives a lot of work for manufacturers and hardly any relevant information for the Member States. The TCAM decision is limiting the notification to exceptions: only in the case you place a radio product on a national market, where it is not allowed to use it. And that will hardly ever happen, so the TCAM decision is a wise one. The present situation is very confusing. Some Member States don t like the TCAM decision and are following the law (like Belgium). Other Member States are not fully aware of the TCAM decision. And there are also Member States who act in accordance to TCAM 3.16.

11 for the R&TTE scheme Page 11 of 38 And last but not least the radio industry doesn t like the notification procedure as defined in the R&TTE Directive. Some large manufacturers want to sabotage the notification. There are plans to notify everything possible (with over thousand notifications per manufacturer). They hope the system will crash. Other manufacturers want to minimize their risks. And because there are no costs involved in the notification, they notify every category 2 product in every country where they place it on the market. This is irrespective whether the product is using the radio frequency spectrum as intended in the country concerned. The advice of Telefication is for the moment: notify everything. As soon as there is more clarity on this subject this document will be changed. The notification is limited to the supply of information. Member States are not allowed to grant an approval or to refuse the placing of the product on their market. Sometimes they do not confirm the receipt of a notification. Telefication offers a notification service. The procedure used by Telefication guarantees the availability of a proper (third party) proof the notification is done on a certain date. After the notification date the manufacturer has to wait four weeks before he is allowed to place the product on the market of the country where the notification is done.

12 for the R&TTE scheme Page 12 of 38 3 The Certification services of Telefication 3.1 Compliant to the R&TTE Driven by a demand from the industry Telefication is developing a new product certification scheme called Compliant to the R&TTE. This demand is driven by the facts that the R&TTE Directive is based on the principle of self declaration and that the requirements coming out of the R&TTE Directive are complex. The result is that signing a Declaration of Conformity -where the manufacturer is declaring his product is meeting the requirements of the R&TTE Directive- is not an unambiguous and risk-free activity. To create the possibility to incorporate the expertise, independence and liability of Telefication in the process of signing a Declaration of Conformity this product certification scheme will be developed. Having a certificate, issued by an experienced and accredited Notified Body like Telefication, stating that the product is meeting the requirements of the R&TTE Directive increases the confidence when signing of a Declaration of Conformity and decreases at the same time the liability. 3.2 Certification of Quality Management Systems with respect to Product Compliance In all Conformity Assessment Procedures of the R&TTE Directive the manufacturer is obliged to meet the requirement Internal Production Control. The purpose of this requirement is that all products produced are meeting the essential requirements of the R&TTE Directive and not only one specimen of the product type. Although the R&TTE Directive does not specify the procedure to achieve this requirement, the manufacturer must guarantee the compliance in his production. There are a lot of alternatives to fulfil this requirement. In general there are two different approaches. The first is product oriented and the second process oriented. In case of a product oriented approach the produced products itself are checked on their compliance. This can be done on all products produced or on a selection of the products produced. A second choice is the scope of the investigation. This can vary from a check on all essential requirements (a complete re-test) to an educated selection of tests related to some key parameters of the product. To realize an acceptable level of confidence the costs can be a disadvantage of this approach, especially in case of high production volumes. In case of a process oriented approach a quality management system is implemented in the production facility. The purpose of such a management system is to ensure all products produced are equal and in conformity to type (the specimen used to prove compliance). A general known standard for such a management system is ISO Telefication developed a process certification scheme specially for the ensuring of product compliance. It is called Compliance in Production Scheme. This scheme is based on a selection of the requirements from ISO 9000 and some verification of the products produced is added. In fact this scheme makes use of the best of the product and process oriented approaches to ensure product compliance in production. Telefication offers certification services for ISO 9000, as well as for the Compliance in Production Scheme. Once chosen for the implementation of a Quality Management System (QMS) the step to an approval of such a QMS by a Notified Body as meant in Annex V of the R&TTE Directive is a small one.

13 for the R&TTE scheme Page 13 of ISO 9000 The ISO 9000 series is a group of international standards comprising both quality management and quality assurance. The requirements specified in the ISO 9000 Standard are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing. The ISO 9000 series are also of help to ensure all products produced are equal to the product for which compliance to the R&TTE Directive was proved. The ISO 9000 series are a general, but suitable tool to fulfil the continued compliance requirement of the R&TTE Directive. Telefication has issued a special document with respect to their ISO 9000 certification service: RD_054, Certification of Quality Management Systems based on the ISO 9000 series. 3.4 Compliance in Production Scheme The Compliance in Production Scheme helps manufacturers with the assurance of the compliance of their products during the production phase. Having developed a compliant product is one thing, but to assure all the products you are producing are also compliant is another thing. This scheme supplies the manufacturer with the requirements to be implemented in his quality system and with a dedicated selection of tests to perform in the factory on the products produced, to verify the products are still compliant. The selection of tests is based on the experience of Telefication as a test laboratory and these tests are just enough to ensure continued compliance - eliminating unnecessary activities and corresponding costs. The scheme is based on product and essential requirement dependent tests, but we are also able to make custom made selection for the specific products and factory involved. With this level of flexibility, special conditions such as the availability of test equipment can be taken into account Telefication will set-out objectives to create maximum effectiveness within the production process and to realize the lowest costs possible. With the R&TTE Directive manufacturers can implement different (and more effective) ways to ensure continued compliance of their products. Telefication is offering a cost-effective and efficient solution. Telefication has issued a special document with respect to this certification scheme: RD_240, Compliance in Production Scheme. More information about the procedure of obtaining certification of a management quality system meeting the requirements of the Compliance in Production Scheme can be found in document RD_053, Certification of Quality Management Systems with respect to Product Compliance.

14 for the R&TTE scheme Page 14 of 38 4 The Test services of Telefication 4.1 Safety testing The essential requirement of article 3.1(a) of the R&TTE Directive is about safety and health and is referring to the Low Voltage Directive (73/23/EEC). The wordings in the Directive are "including the objectives of the Low Voltage Directive (LVD)". Formally this text implies that meeting standards published as harmonized standards under the LVD is not enough to obtain the preassumption the product is in compliance with this essential requirement. The absence of harmonized standards published under the R&TTE Directive to be used for this essential requirement would -formally spoken- imply that for this essential the Conformity Assessment Procedures as defined in Annex II and III are not available! After discussions with the European TCAM Secretary with respect to this subject Telefication advises their customers to read this essential requirement as "comply with the LVD". On top of that additional attention to "Acoustic shock" and "Influence of electromagnetic radiation on the human body" (SAR) is advisable for some products. Be aware that the R&TTE Directive eliminated the voltage limits of the LVD. This implies that all products falling under the scope of the R&TTE Directive have to comply (at least) with the LVD. Even products without a battery or power supply have to comply with the LVD. The consequence is that products approved before 8 April 2000 have to meet additional technical requirements when transferring them to the R&TTE Directive (which have to be done before 8 April 2001). Conclusion: A test to a European harmonized standard published under the LVD is a good starting point for every R&TTE product in order to meet the article 3.1(a) essential requirement of the R&TTE Directive. All harmonized standards published under the LVD Directive can be used to obtain the preassumption of compliance with the requirements of the LVD. You can find a list of all European harmonized standards published under the LVD Directive in Safety testing is available in the test laboratory of Telefication. For the latest information see EMC testing The essential requirement of article 3.1(b) of the R&TTE Directive is one on one linked to the EMC Directive (89/336/EEC). All harmonized standards published under the EMC Directive can be used to obtain the preassumption of compliance with this essential requirement of the R&TTE Directive. You can find a list of all European harmonized standards published under the EMC Directive in EMC testing is available in the Telefication test laboratory. For the latest information with respect to: Radio products see TTE products see

15 for the R&TTE scheme Page 15 of Radio testing The essential requirement of article 3.2 of the R&TTE Directive is about effective use of the spectrum. All harmonized standards published under the R&TTE Directive can be used to obtain the preassumption of compliance with the radio requirements of the R&TTE. You can find a list of all European harmonized standards published under the R&TTE Directive in As you will see there are at the moment just a limited number of harmonized standards published under the R&TTE Directive. The consequence is that for a lot of products using the radio spectrum there are no harmonized standards available. These standards are under development (at ETSI). Due to absence of applicable harmonized standards for the radio essential, manufacturers cannot use Annex III to prove compliance for some radio products. The only remaining alternatives for these products are Annex IV and V. In both remaining conformity assessment procedures a Technical Construction File (TCF) has to be created. The easiest way to realize a TCF for the radio essential is to perform testing to an applicable national standard or applicable ETS/EN specification. When ordering an Annex IV Statement of Opinion (see chapter 7), Telefication will deliver a free of charge information service, supplying the manufacturer with the identification of the (nonharmonized) standards, which can be used for proving compliance to the radio essential. It is essential for this service, that Telefication has the correct product documentation (or accurate information about the product characteristics) at their disposal. Radio testing is available in our laboratory. For the latest information see Article 3.3 testing At the moment there are no products for which an essential requirement exists as defined in article 3.3 of the R&TTE Directive. As soon as such an essential requirement becomes applicable for one or more classes of products, Telefication will develop if not ready available- an applicable test service. Test services of Telefication related to essential requirements of article 3.3 can be found at EMF (RF Safety) testing All products falling under the scope of the R&TTE Directive have to be safe, see article 3.1(a). The European Commission published the Council Recommendation of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (1999/519/EC). The document can be found at At the moment no harmonized standards are available to proof compliance with this requirement. The European Commission published the Draft standardisation mandate addressed to CEN, CENELEC and ETSI in the field of electro technology, information technology and telecommunications in order to create these standards. The document can be found at

16 for the R&TTE scheme Page 16 of 38 As long as no harmonized standards are available to proof compliance with EMF (RF Safety) Annex III cannot be used as a Conformity Assessment Procedure for Radio transmitters. The available procedures are Annex IV and V. As soon as harmonized standards are available Telefication will deliver a test service for these standards. At the moment Telefication can assist manufacturers in the compilation of a Technical Construction File to proof, with other means than the use of a harmonized standard, that the Radio transmitter is safe with respect to EMF. 4.6 Creation of Technical Construction File (TCF) The policy of Telefication is that Telefication will not compile a TCF. The Manufacturer should provide the complete TCF. The use of a harmonized standard to prove a product is meeting an essential requirement is voluntary. When a product is in compliance with a harmonized standard the pre-assumption exists the product is meeting the relevant essential requirement. It is also possible to prove a product is meeting an essential requirement without the use of a harmonized standard (as defined in Annex IV). This can be done by any means. Examples are the use of non-harmonized (i.e. national) standards, references to similar/equal products, calculations, educated estimations, deduction, etc, etc. The intention of Annex IV of the R&TTE Directive was to limit the use of the TCF to the radio essential (article 3.2). The actual wordings in the R&TTE Directive are however not restricting the use of Annex IV to the radio essential. Proving compliance to any of the R&TTE essential requirements can be done by using Annex IV. When using a TCF as proof for compliance you always need a Statement of Opinion delivered by a Notified Body (see chapter 7).

17 for the R&TTE scheme Page 17 of 38 5 Conformity Assessment Procedures of the R&TTE Directive 5.1 Overview To prove your product complies with the essential requirements of the R&TTE Directive you can use four different conformity assessment procedures. The use of two conformity assessment procedures is dependent on the product (TTE = Telecommunication Terminal Equipment, RR = Radio Receiver and RT = Radio Transmitter): In case of TTE or RR: Annex II = Declaration of Conformity (DoC) In case of RT: Annex III = DoC and specific radio-tests (DoC+) When using Annex II or Annex III the manufacturer needs to apply Harmonised Standards. When there are no Harmonised Standards available or applied the manufacturer has two alternatives available (independent of the type of product): In the next figure a flowchart is given. Annex IV = Technical Construction File (TCF) Annex V = Full Quality Assurance (FQA) Conformity Assesment Procedure? YES Go for FQA? (~ISO 9001) NO YES Harmonised Standards used? NO / YES (*) NO Product a Radio Transmitter? YES Use Annex V = FQA Use Annex II = DoC Use Annex III = DoC+ Use Annex IV = TCF (*) When you applied a Harmonised Standard to prove your product meets an essential requirement you are allowed to use Annex IV, although this is not obliged. Some manufacturers like to have the involvement of a third party with a respectable expertise of the R&TTE Directive to verify their work. The Statement of Opinion as defined in Annex IV is an effective solution for this demand. Figure 2: Choices of Conformity Assessment Procedures There are in total 9 essential requirements defined by the Directive (see Annex B). Three of them are always applicable (Safety, Electromagnetic Compatibility and Effective use of the spectrum). One of them (Effective use of the spectrum) is only relevant when the product is an intended radiator (a radio transmitter). The other 6 are possible essential requirements, which can be made applicable if needed (following the procedure, according article 15).

18 for the R&TTE scheme Page 18 of 38 Manufacturers are allowed to use a separate conformity assessment procedure for every essential requirement (within the restrictions given in the flow chart above). Ultimately regardless the choice of the conformity assessment procedure- the manufacturer has to draw up and sign a Declaration of Conformity, with reference to all applicable essential requirements. An example: A specific radio-transmitter has to meet with three essential requirements: Safety, Electromagnetic Compatibility and Effective use of the spectrum. You can choose a separate conformity assessment procedure for every of the three essential requirements. Because the product is a radio-transmitter Annex II is not available. The other three conformity assessment procedures can be applied for each of the three essential requirements. In total you will have 27 options! One of these options is Annex III for Effective use of the spectrum, Annex IV for Safety and Annex V for Electromagnetic Compatibility. 5.2 Differences of the several Conformity Assessment Procedures The Conformity Assessment Procedures are defined in Annex II to V of the Directive. Annex II is a subset of Annex III, whilst Annex III is a subset of Annex IV. Annex II and Annex III are both based on Self Declaration. Annex V is based on Self Certification. Annex IV is in between Self Declaration and Self Certification. For Annex IV a Notified Body is needed, but their authorisation is limited to deliver an opinion. A manufacturer can formally neglect such an opinion from a Notified Body. Whether that will be a wise decision, when the opinion is negative, is another case. In the following table an overview is given of some activities defined by these annexes, which have to be fulfilled by or on behalf of the manufacturer. PROVING COMPLIANCE ARCHIVING (FOR > 10 YEARS) USING NOTIFIED BODY(S) MAKING DECLARATION(S) II DoC III DoC + ANNEX TESTS TO HARMONISED STANDARDS TECHNICAL DOCUMENTATION - 1) - V FQA QUALITY SYSTEM APPROVAL RADIO TESTS - PERFORMED DECLARATION OF CONFORMITY IV TCF OTHER MEANS TECHNICAL CONSTRUCTION FILE STATEMENT(S) OF OPINION CONFORMITY TO RADIO TEST SUITES 1) Identification of the radio tests to be performed. Formally in the Directive, but practically not applicable (they will be defined in the harmonized standards). Table 1: Differences between the several Conformity Assessment Procedures. As you can see there is a role for a Notified Body under Annex III, Annex IV and Annex V. The Notified Body services of Telefication are described in the chapters 6, 7 and 8. The choice of the conformity assessment procedure and all their aspects is an item of our R&TTE Package. See chapter 2 for a description of the R&TTE Package.

19 for the R&TTE scheme Page 19 of The Telefication Approach and the R&TTE Directive The Global Approach, which is the basis for almost all the European Directives with respect to product compliance, describes procedures for the assessment of products. Each procedure comprises both the design phase and production phase of a product. The procedures differ in nature and are applied according to the potential risk associated with a non-compliance product. For instance, pacemakers have to satisfy much more stringent assessment requirements than toy trains. Depending on the risk associated with a particular product, Directives specify in which cases the manufacturer himself may determine whether the products conform to the essential requirements in the Directive(s) and in which cases this has to be assessed by a third party, a Notified Body, by means of certification. Telefication as a certification body has developed the Telefication Approach, which is a superset of the Global Approach. The Telefication approach can also be used for approval scheme outside Europe and for voluntary product certification. 5.4 Notified Body services of Telefication The following conformity assessment procedures apply to equipment falling under the scope of the R&TTE: Internal Production Control (Annex II); Internal Production Control plus specific test (Annex III); Full Quality Assurance (Annex V); Technical Construction File (Annex IV). The basic features and the related modules of the Telefication Approach of these procedures are as follows: Internal production control The manufacturer assesses both the design and production of his products himself. This is called Self-Declaration. The applicable procedure of the Telefication Approach is Module A. In Module A no role is defined for Telefication as a certification body / Notified Body. Internal production control plus specific tests The manufacturer assesses both the design and production of his products himself. In addition to that the manufacturer has to perform specific radio tests. In case those tests are not defined by Harmonised Standards, a Notified Body defines those tests. The manufacturer must declare that all selected/defined tests have been carried out and that compliance is established. The applicable procedure of the Telefication Approach is Module Aa. Full quality assurance A Notified Body assesses whether the manufacturer has sufficient expertise to design, test, and verify products according to the standard, and whether he has a Quality Management System of a sufficiently high standard to guarantee that the products satisfy the (statutory) requirements. The applicable procedure of the Telefication Approach is Module H. Technical Construction File Definition of Technical Construction File in accordance R&TTE Directive 1999/5/, annex 4: The technical documentation described in point 4 of annex 2 and the declaration of conformity to specific radio tests suites described in annex 3 must form a technical construction file. The manufacturer has to prove compliance of the product to one or more of the essential requirements without the use of tests to Harmonised Standards. This proof has to be added to the Technical Documentation. A Notified Body will assess the TCF. The applicable procedure of the Telefication Approach is Module Ba.

20 for the R&TTE scheme Page 20 of 38 The different possibilities are given in table 2. Module A Module Aa Module H Module Ba Annex II Annex III Annex V Annex IV Telecommunication Terminal Equipment X X (X) Harmonised Standards are applied Radio Equipment Harmonised Standards are applied X X (X) All Equipment No (or partly) Harmonised Standards are applied (X) Not explicitly mentioned in the R&TTE Directive. X X Table 2: Restrictions in use of the several Conformity Assessment Procedures. In the modules A and Aa the involvement of a Test laboratory is needed. In the modules H and Ba Test laboratories can be used, but the involvement of a Notified Body is needed. Notified Body Telefication is a certification body who is authorised to implement the tasks relating to the conformity assessment procedures defined by the R&TTE Directive. Test laboratory A test laboratory is capable to perform tests, which is part of some of the conformity assessment procedures. A laboratory could be accredited on the basis of an assessment in accordance with a quality standard, i.e. EN 45001, ISO Guide 25 or IEC/ISO Guide There is no legal obligation to use an accredited laboratory. Manufacturers are taking aspects like quality, policy, liability, procurement requirements, costs, etc. into account determining whether tests are outsourced and to whom. The listed test laboratories of Telefication are accredited to EN45001 and/or to ISO Guide 25.

21 for the R&TTE scheme Page 21 of 38 6 Applying for an Overview of the specific radio tests (Annex III) 6.1 Introduction Annex II is a subset of Annex III. This means that all obligations defined in Annex II are also applicable for Annex III. In the next paragraphs respectively the obligations of Annex II and III are given. 6.2 Annex II (Internal production control) This procedure can only be applied for Telecommunication Terminal Equipment (TTE) or Radio Receivers (RR), but the obligations of it are included in Annex III (which is for Radio Transmitters). The essence of this procedure is that the manufacturer himself shall verify the compliance of the equipment with the provisions of the Directive. The most important obligations are: Verify by means of testing to Harmonised Standards the compliance of the product; Create a file called Technical Documentation; Draw up a written Declaration of Conformity; Affix the appropriate CE marking to each product; Archive the Technical Documentation for a period of at least ten years after the last product is produced. 6.3 Annex III (Internal production control plus specific tests) This procedure is applicable to transmitting radio equipment for which Harmonised Standards are applied and consist of Annex II supplemented by the following obligations: Carry out for each radio type a certain set of essential radio tests; Declare that all selected tests have been carried out and that compliance is established. The certain set of essential radio tests has to be defined by test suites according to a Harmonized Standard or by a Notified Body. 6.4 Overview of the specific radio tests Telefication will investigate which specific radio tests the manufacturer must perform. The investigation shall be based on the specific radio characteristics of the product involved. The manufacturer will obtain an Overview of the specific radio tests. This is the formal description of the Annex III Notified Body service of Telefication. In practice the manufacturers do not need this service. When the Directive came into force the assumption was made, that the information which specific radio tests must be performed, would not be publicly available. Now the general expectation is that for every Harmonized Standard published in the Official Journal the specific radio tests will be indicated.

22 for the R&TTE scheme Page 22 of 38 7 Applying for the Statement of Opinion (Annex IV) 7.1 Annex IV (Technical Construction File) Definition of Technical Construction File in accordance R&TTE Directive 1999/5/, annex 4: The technical documentation described in point 4 of annex 2 and the declaration of conformity to specific radio tests suites described in annex 3 must form a technical construction file. This procedure is in particular designed for equipment for which no, or partly, Harmonised Standards are applied. It consists of Module B of the Telefication Approach. The following requirements are applicable: The manufacturer must present its Technical Construction File containing all information to one or more Notified Bodies. The Notified Body shall review the Technical Construction File and may give his opinion if it is considered that the given information is insufficient to demonstrate that the requirements of the Directive are met. The Notified Body give his opinion within four weeks. After that period the product may be marketed. The manufacturer must affix the Notified Body number(s) together with the CE mark on the product. 7.2 Time to market The procedure of Annex IV is based on the assumption that no (negative) opinion received within four weeks means the TCF gives enough information to conclude the product complies with the essential requirement(s). This approach is introducing a lead-time of four weeks before the manufacturer can place his product on the market. To eliminate this barrier in the time to market Telefication will always issue an opinion. Independent whether the opinion of Telefication is positive or negative the manufacturer will receive this opinion as soon as possible. To realise the shortest time to market Telefication has chosen for performing a type-examination as their implementation of this Annex IV. 7.3 Flow diagram The implementation of Annex IV by Telefication is similar to normal product certification. The result of the type-examination is not a Certificate of Approval, but the legal needed Statement of Opinion. On the next page a flow diagram is given of the assessment procedure.

23 for the R&TTE scheme Page 23 of 38 Product Type-examination Statement of Opinion Registration Figure 3: The assessment procedure of Annex IV. The type-examination can take the following forms: 1. The manufacturer or importer has the equipment tested by an (accredited) laboratory of his choice. He should then submit the application together with the TCF and all other relevant documentation to Telefication; 2. The manufacturer submits an application directly to Telefication together with the relevant supporting documentation. Telefication will assess the submission and if Telefication is of opinion that the product needs to be tested, this will take place in consultation with the applicant. There are no restrictions concerning who may apply or the place of establishment of the applicant; everyone may submit an application. However, the application should preferably be submitted by the manufacturer. Application forms are available from Telefication (see also Annex D). The application and the accompanying documentation may be submitted in Dutch, English, French, German, Italian or Spanish, where English is preferred. The Statement of Opinion declares that the listed equipment shows no non-compliances with the essential requirements in accordance with Article 3 of the Directive 1999/5/EC as far as applicable for the product involved and as far as is specified in the order granted to Telefication. The Statement can be issued for none, one or more of the essential requirements according to the specification of the order (see Annex B). 7.4 Product variants Product A product is unique in its construction. A product may be marketed as a variant, however all of these variations need to be assessed by Telefication. OEM products and product variants can be added to a Statement of Opinion if they comply with the following conditions. OEM product

24 for the R&TTE scheme Page 24 of 38 One may market the same product under different type designations and/or trademarks. The products are 100% identical, in construction, hardware, software and physical outlining (OEM = Original Equipment Manufacturer). Product variants category one Product variants category one are products that are almost identical, but differ in some small detail. Products that fall under this category are for instance the so-called stripped versions, where components are skipped to achieve for example less extensions, etc. Product variants category two Products that are identical at large, but differ more than the previous mentioned products, will fall under category two. Examples of these products are: A different PCB layout is used while the electronic design is the same; Addition of more options to the same basic product; etc. 7.5 The Statement of Opinion Telefication will, if the Type-examination procedure has been completed, issue a Statement of Opinion. Any Statement of Opinion issued by Telefication will contain at least the following data: The name and address of the manufacturer and the holder of the Statement, and data to identify the terminal equipment; The name and address of Telefication; Registration number; Product description; The type designation of the product and of each variant if any; Date of issue and signature. The annexes accompanying the Statement of Opinion contain information on the technical specifications on the basis of which the Statement of Opinion was issued and any conditions for its validity, such as: Description of equipment use; References to the technical standards to which the equipment is assessed. The Statement is not transferable without the intervention of Telefication.

25 for the R&TTE scheme Page 25 of 38 8 Applying for Approval of Quality Management System (Annex V) 8.1 Annex V (Full Quality Assurance) Annex V is on the approval of a Quality Management System (QMS). This QMS will guarantee that all products designed and produced by the manufacturer, who has implemented this QMS, will meet the requirements of the Directive. Telefication will audit the QMS and issue a Certificate of Approval, when the QMS is meeting the requirements of the Directive. The procedure, which will be used by Telefication for performing these audits, is described in RD_053, Certification of Quality Management Systems with respect to Product Compliance. The products are not examined by Telefication. The manufacturer is operating on a quality level where the compliance of the products is assured. For that reason this conformity assessment procedure is sometimes called Self Certification. 8.2 Alternatives The straightforward approach is to implement a Quality Management System (QMS) concerning the design as well as the production phase (Full Quality Assurance). The investments to realize this can be reduced by starting with the implementation of a QMS just for the production phase. Such a QMS is called Production Quality Assurance. The requirements of the design phase can be realized by subcontracting the tests to an accredited test laboratory. So in principle there are the following two alternatives: Full Quality Assurance [Module H]; Production Quality Assurance [Module D] and accredited testing. 8.3 Full Quality Assurance [Module H] Annex V of the Directive is based upon module H of the Global Approach. The Telefication Approach is a superset of the modules defined in the Global Approach. Telefication is using Full Quality Assurance [module H] of the Telefication Approach to assess whether the quality system of the manufacturer is meeting the requirements of Annex V of the Directive. The document RD_008, Full Quality Assurance [Module H] describes the quality system requirements and procedures for assessment based on module H of the Telefication Approach. The designation mentioned in RD_008, Full Quality Assurance [Module H] must be based on the standards published in the Official Journal under the LVD, EMC or R&TTE Directive or when not available on the applicable essential requirements. 8.4 Production Quality Assurance [Module D] and accredited testing Telefication is using Production Quality Assurance [module D] of the Telefication Approach to assess whether the quality system of the manufacturer is meeting the requirements of Annex V of the Directive as far as related to the production phase. When the manufacturer has added to his Quality Management System the policy, that all the tests relevant for proofing compliance of his products will be subcontracted to an accredited test laboratory, then also the requirements of Annex V with respect to the design phase are met. Accredited means that the test laboratory complies with EN and that a member of the European co-operation for Accreditation (EA) is responsible for the accreditation. Accreditation by an Accreditation Body having a Multilateral Recognition Agreement (MLA) with the EA is also meeting the requirements.