NORMAPME Experts Tool Kit. A travel guide to the standardisation world. Being a NORMAPME s expert Role & Objectives

Transcription

1 NORMAPME Experts Tool Kit A travel guide to the standardisation world Being a NORMAPME s expert Role & Objectives Page 2-4 SMEs & standards : Organisations and Process The expert & NORMAPME Page 5-10 Page Page NORMAPME, the European Office of Crafts, Trades and Small and Medium sized Enterprises for Contact: info@normapme.com

2 Table of Contents 1 BEING A NORMAPME S EXPERT: YOUR ROLE, YOUR OBJECTIVES NORMAPME S EXPERTS IN TECHNICAL COMMITTEE(S) (TCS) OBJECTIVE: MORE SME-FRIENDLY STANDARDS, INCREASED USE OF EUROPEAN STANDARDS AMONG SMES 3 2 SMES AND STANDARDS WHY STANDARDS ARE IMPORTANT FOR SMES? WHAT IS STANDARDISATION? WHAT IS A STANDARD? WHAT IS A HARMONISED STANDARD? THE NEW LEGAL FRAMEWORK THE CE MARKING STANDARDISATION ORGANISATIONS AND THE STANDARDISATION PROCESS INTERNATIONAL, EUROPEAN AND NATIONAL STANDARDISATION ORGANISATIONS International standardisation European standardisation standardisation THE CEN STANDARDISATION PROCESS THE CENELEC STANDARDISATION PROCESS ETSI WHAT ARE THE DIFFERENT STEPS IN THE DEVELOPMENT OF A STANDARD? How long does it take to develop a standard? THE EXPERT AND NORMAPME WHAT ARE THE NORMAPME MIRROR COMMITTEES? WHO CAN PARTICIPATE IN NORMAPME MIRROR COMMITTEES? THE RELATIONS OF THE EXPERTS WITH THE STAFF AND THE SECRETARIAT OF NORMAPME Expert and Technical Committee NORMAPME services THE LIVELINK USEFUL LINKS REFERENCES WEBSITES: ENCLOSED DOCUMENTS

3 1 Being a NORMAPME s expert: your role, your objectives NORMAPME is an international non-profit association created with the support of the European Commission, under the full name of the "European Office of Crafts, Trades and Small and Medium-Sized Enterprises (SMEs) for ". NORMAPME s members are associations representing SMEs either at national level in the EU 1 /EFTA 2 countries or at European level. NORMAPME, as the body representing crafts and SMEs interest in the standardisation area, receives financial support from the European Commission. NORMAPME s provides services aimed at the promotion of crafts and SMEs interests in standardisation. NORMAPME is an Associate Member of CEN, the European Committee for and a Cooperating Partner of CENELEC, the European Committee for Electrotechnical. It is also a Full Member of ETSI, the European Telecommunication Standards Institute and has the status of Cooperating Organisation at ISO, the International Standards Organisation. As such, NORMAPME has a seat in the managing bodies of the European Standards Organisations (ESO). Similarly, NORMAPME is entitled to appoint experts in Technical Committees (TC). In September 2010, NORMAPME is involved in 52 Technical Committees, either at European or at International level. 1.1 NORMAPME s experts in Technical Committee(s) (TCs) NORMAPME appoints experts in TCs to ensure that SMEs positions are taken into account in the standardisation processes and to increase the understanding of SMEs needs among standards drafters. NORMAPME experts are supported by: NORMAPME standardisation project managers that ensure liaison with the organisation s secretariat, run SMEs consultations and assist the experts; NORMAPME mirror committees: composed of SME experts from different countries; they ensure that the nominated experts represent a pan-european point of views by providing input and feedback to the expert. Participation in mirror committees is open to all experts supported by SME representative associations. 1 European Union 2 European Fair Trade Association (Iceland, Liechtenstein, Norway and Switzerland) 2

4 The tasks of NORMAPME experts include the following: Introduce himself, his role and give to the other members of the TCs the form "the role of Normapme experts in TCs; Attend meetings of relevant Working Group(s) (WGs) of the TC; Actively contribute to the standardisation work taking place in the WG(s)/TC; Identify issues of concern for SMEs; Develop proposals and comments taking into account SMEs needs; Liaise with NORMAPME mirror committees and NORMAPME secretariat in order to ensure that his/her positions are fully SME representative; Report to NORMAPME secretariat. 1.2 Objective: more SME-friendly standards, increased use of European Standards among SMEs SMEs represent the strength and the uniqueness of the European economy and society. They are approximately 24 Million in 30 European countries and account for 99% of all enterprises. They contribute to almost two thirds of EU s gross domestic product and provide more than half of European employment. SMEs are often not sufficiently represented in the standardisation process and standards are frequently found not adapted to SMEs needs. Better participation and SMEs and representation of their interests in the standardisation processes can be addressed by working upstream the standardisation system: NORMAPME appoints SME experts in TCs that are assessed to be relevant for SMEs; such experts contribute to the TC s work and draw attention on the specific needs of SMEs in standards. The results of this approach are standards more SME friendly, better responding to the SMEs need and more used by SMEs. The most common issues for SMEs in standards are the following: technical/academic language non-linear approach amount of references to other standards length of standard clarity of language: o explanations of terminology o explanations of the relevance of references o clarity of scope o use of illustrations o explanatory examples special provisions for SMEs/ non-series production expensive conformity procedures, eg destructive tests exclusion of technologies used by SMEs development of new standards not needed by SMEs 3

5 In addition to the activities SME experts in TCs, NORMAPME promotes measures that increase the SME friendliness of the standardisation environment. Guide 17 a concrete tool for the NORMAPME expert The NORMAPME expert can also promote and work with the CEN-CENELEC Guide 17 Guidance for writing European Standards taking into account micro, small and medium-sized enterprises (SMEs) needs. It raises awareness on the issues that may be of importance to SMEs in the development of standards with the ultimate aim of increasing the uptake of European Standards amongst SMEs. Providing advice and a useful checklist, the Guide addresses the issues to be considered during the development process of preparing European Standards relevant to SMEs. The guide provides recommendations to standard writers on how to take into account SME needs by identifying issues that should be considered during the development process of standards. Standards should be for instance, written in a clear and easy to understand language and excessive testing costs should be avoided. To this end a useful checklist is included. The guide is a joint initiative of NORMAPME and CEN and CENELEC. It was published in its English original version in June To make it easier for standard writers and SMEs to read and apply the CEN-CENELEC Guide 17, national language versions of the guide are provided and free for download on the NORMAPME website and on the CEN-CENELEC website. 4

6 2 SMEs and standards 2.1 Why standards are important for SMEs? There are clear, tangible benefits for SMEs in using standards. They can use established standards in the development of new products in order to reduce the resources spent on research and development and improve their ability to innovate. They can also employ best-practice guidelines to increase efficiency, improve safety and measure performance. And by proving they adhere to standards, they can win new customers and retain existing ones by demonstrating the quality of products. The potential benefits for SMEs far exceed the cost of accessing and using standards. The benefits of standards compliance can be summarised as follows: Compliance to regulation Presumption of conformity: regulations allow 'presumption of conformity' for products complying with certain standards. Compliance with standards enables manufacturers to demonstrate the suitability of their own technology, providing them greater flexibility. Customer assurance & reduced product liability: safety and other standards help reassure customers that the product is safe and reliable. This increases product acceptance on the market. Standards thus demonstrate the firm's commitment to health, safety and environmental rules. Risk Management: standards are privileged documents for legislation, which may include antitrust protection. Firms can thus reduce their risk from legal actions, including competition policy, by use of standards. Governance: process standards help define internal procedures for organisations. Complying with such standards is often a requirement when bidding for contracts, particularly in public procurements. Revenue and market access Improved access to market: introducing a standard-compliant product into a market where the standard is already established often results in a greater acceptance of the product. Exports and product acceptance: the market ability of a product is often fully dependent of conformity with local standards and regulation, including health, safety and environmental rules. This especially affects entry to international markets. Product life cycle management: the typical life cycle of new products is invention, market introduction and acceptance, growth, maturity and eventual decline. Initially, protecting intellectual property is likely to be the most important concern for the organisation seeking to exploit the new product. However, as the product searches for greater market acceptance and adoption, then the use of standards becomes an increasingly important part of the strategy. 5

7 Costs reduction Reduced transaction costs: standards simplify component specifications, allow economies of scale, easier maintenance and support. Product/process interoperability: standards are increasingly developed for a complete system or process, to enable all components to work together consistently. The classic example of this is the open architecture used in computers and product interoperability. Flexibility in supply chain: manufacturers of products that conform to standards are likely to have a greater choice of suppliers (who are attracted by the large market for standard components) and as such will benefit from lower costs derived from supplier competition and economies of scale. Understanding best practice & management systems: process standards and management systems codify best practice, enabling organisations make use of the knowledge and experience of experts in management, rather than undergo the time, cost and uncertainty of developing their own protocols. Opportunity New markets opportunities: standards can help defining the design of a new product, ensuring it is compatible with other products on the market and establishing a new product on the market. Influence on technology change & industry evolution: in progressive industries, characterised by continuous innovation and multiple generations of technology, standards constantly need to be developed. They define the new products, by specifying key features for compatibility, reliability and quality, and provide the basis for development of complementary products and services that interface with the core product. Securing influence over evolving technical standards can create crucial competitive advantage. Structure of Regional / International Competition: essentially, harmonized standards increase the opportunity for firms to successfully export. 2.2 What is standardisation? is: a collective work based on consensus amongst all stakeholders (Industry, SMEs, consumers, workers, public authorities, non governmental organisations, universities, research bodies, etc ); lead by independent, officially recognised bodies at, European and global levels; increasingly used by EU authorities as a tool in their legislation, for technical harmonisation, ICT, public procurement, environment, competitiveness, safety & health, consumer protection. 6

8 2.3 What is a standard? A standard is a document that is: established by consensus, on a voluntary basis, by the main stakeholders; approved by recognised body providing for common and repeated use rules, guidelines or characteristics for activities or their results; a summary of best practices on a given product or process; based on the consolidated results of science, technology and experience; publicly available in all stages of standardisation process until ratification. European Standards (ENs) are documents that have been ratified by one of the 3 European Standards Organizations, CEN, CENELEC or ETSI. They are designed and created by all interested parties through a transparent, consensual process. ENs are a key component of the Single European Market and are crucial in facilitating trade. The fact that European Standards must be transposed into a national standard in all member countries guarantees that a manufacturer has easier access to the market of all these European countries when applying European Standards. Member countries must also withdraw any conflicting national standard: the EN prevails over any national standard. 2.4 What is a harmonised standard? Harmonised standards are European standards, adopted by one of the European Organisations, following a mandate issued by the European Commission after consultation of Member States. Compliance with harmonised standards, of which the reference numbers have been published in the Official Journal and which have been transposed into national standards, provides presumption of conformity to the corresponding essential requirements of the European directives. In the case of New Approach Directives, compliance with harmonised standards means CE marking conformity. Although CE marking compliance can be demonstrated by other means than compliance with harmonised standards, it remains the easiest way. 7

9 2.5 The new legal framework The creation of the Single Market in Europe was laid down in four basic principles commonly identified as the 4 freedoms that refer to the free movement of goods, services, capital and workers. The principal goal of the Single Market was to eliminate all barriers to trade existing between the Member States. In order to faster remove these barriers, a new legislative technique and strategy was established: The New Approach. This new legal framework, the New Approach to Technical Harmonization and (1985), was created in order to "harmonize" the health, safety, and environmental requirements of Member States into one single European legislative package. The outcome was called New Approach Directives, which are broad regulatory requirements to which confronted products must conform. Member States are obliged to adopt the New Approach Directives because European legislation always prevails over national one, which must be replaced. The New Approach represents a major change in policy for it makes reference to voluntary EN as the most appropriate method for technical implementation of legally-imposed requirements for products under European law. With the New Approach, the European Commission proposed the necessary mandatory performance requirements to ensure health, safety, etc. and asked the 3 recognized European Standards Organizations (CEN, CENELEC and ETSI), who create standards with the help of technical experts, the application of the principles that guarantee compliance with the corresponding requirements. The Global Approach to Testing, Certification and Conformity Assessment, adopted in 1989, supplements the New Approach. It provided for the establishment of harmonized procedures to assess the conformity of products with the requirements of the New Approach Directives and the placing of the CE Marking to such products. Notified Bodies, which are officially recognized organizations within Member States, can certify conformity on the basis of the New Approach, if required by the Directive in question. Adopted New Approach Directives are notified to Member States and published in the L series of the Official Journal of the European Communities (OJEC). Commission proposals for New Approach Directives are published in the C series of the Official Journal. New Approach Directives are based on the following principles: Legislation is restricted to regulatory specifications that must be met before products can be placed on the European market place. These specifications are outlined in the New Approach Directives and mainly refer to essential requirements that are of public interest (health and safety). The necessary standards ensuring that products meet these regulatory requirements are created by the competent recognized European Organization, CEN, CENELEC or ETSI, depending on the field of work, under a contractual relationship with the European Commission (and the EFTA Secretariat), known as a mandate. They will be called harmonized standards. 8

10 The references to harmonized standards will be published in the OJEC. It is only from this moment that the harmonized standards will grant presumption of conformity. Application of harmonized standards or other technical specifications remains voluntary. Manufacturers are always free to choose any technical solution that provides compliance with the essential requirements set by the Directive. This is a very important clause for it guarantees the ground for technical development, crucial when manufacturers of new or innovative products for which standards do not yet exist want to certify their products according to the legal European framework. Only products fulfilling the essential requirements may be placed on the European market and put into service. authorities must acknowledge that products manufactured in conformity to harmonized standards are presumed to conform to all the necessary legal requirements established by the Directives. Manufacturers may choose between different conformity assessment procedures provided for in the applicable Directive. A fundamental principle of the New Approach is to limit legislative harmonization to the essential requirements that are of public interest. These requirements deal in particular with the protection of health and safety of users (usually consumers and workers) although sometimes cover other fundamental requisites, like protection of the environment. Complying with the essential requirements is mandatory because they lay down the necessary elements for the protection of the public interest. All manufacturers are obliged to meet these legallybinding requirements specific to each product. Conformity Assessment is the process by which compliance with the essential requirements set by the Directives is determined. This process may be carried out with or without the use of standards. This principle is important to manufacturers of avant-garde products for which standards do not yet exist for it ensures that harmonized standards do not become the only technical solution, consequently impeding technological development. If a manufacturer decides not to apply harmonized standards, he may do so and market the product directly on the basis of the essential requirements, although he will have to demonstrate compliance. In other words: products placed on the market must comply with legislation but not necessarily with standards. 2.6 The CE Marking The EU s New Approach to Technical Harmonization and Standards aims to ensure that only products meeting the requirements set by the EU legislation can circulate within the EU. The CE Marking was therefore chosen as an easily identifiable label to indicate compliance with these requirements. The CE Marking is a declaration of conformity with European legislation designed to show all parties concerned that a product meets all the appropriate requirements specified by New Approach Directives. It may be compared to a passport for entrance into the EU market. CE in the term CE Marking stands for Conformité Européenne (European Conformity) and as stated above, it only applies to products that are governed by at least one of the New Approach Directives. Nevertheless, it must be stressed that it is compulsory to 9

11 affix it on all products for which one of these Directives applies. If a product is covered by more than one New Approach Directive, the CE Marking symbolises that the product conforms to all New Approach Directives applying to it. The CE Marking may certainly be called the passport to Europe for products. CE Marking a product that falls under one of the New Approach Directives is not an option for the manufacturer, it is simply required by law. All manufacturers, regardless of the product s origin or the plant s location, are required to affix this CE Marking to products that are governed by New Approach Directives. The CE Marking should not be confused with quality marks or labels for consumers to identify the excellence of a product. It is a visible sign affixed by the supplier of the product to show EU member states authorities and other parties concerned that the product is in compliance with all the New Approach Directives applying to it. It is the manufacturer or his Authorized Representative, established in the European Union, who affixes the CE Marking to the product. It is certainly not affixed by a Notified Body (officially recognized bodies that conduct Conformity Assessment tests for products that fall under those New Approach Directives that require this compliance procedure). The CE Marking must be affixed visibly, legibly and indelibly to the product, to its data plate or, where this is not possible, to its packaging. Where a Notified Body is involved in the production control phase according to the applicable Directives, its identification number must follow the CE Marking. More complete instructions for the design and placing of the CE Marking are available in the Directive 93/68/EEC, also referred to as the CE Marking Directive. 10

12 3 Organisations and the process 3.1 International, European and national standardisation Organisations International ISO /IEC/ITU WTO Europe CEN/CENELEC/ETSI EC EFTA Membership NSBs for CEN & CENELEC Companies for ETSI authorities 3 is a process that simultaneously takes place at three parallel levels: national, european and international. The three levels are complimentary International standardisation The elaboration of international standards is the responsibility of international standards organisations. There are three such organisations: The International Standards Organisation, ISO, regrouping the official national standards organisations from 159 countries and following the practice recommended by the WTO (World Trade Organisation). CEN is the European counterpart and their relationship is governed by the Vienna Agreement signed in IEC: International Electro technical Commission ITU: International Telecommunication Union WTO: World Trade Organization EC: European Commission EFTA: European Fair Trade Association (Iceland, Liechtenstein, Norway and Switzerland NSB: Body (DIN, AFNOR, BSI, UNI, AENOR...) 11

13 The International Electro technical Commission, IEC that produces standards recognized by the WTO. CENELEC is the European counterpart and their relationship is governed by the Dresden Agreement approved in The International Telecommunication Union, ITU. ETSI is the European counterpart European standardisation The European Union has used the European standardisation system to dismantle the technical barriers to trade and to the Internal Market within the EU. At European level, the European Organisations responsible for organising the process leading to the creation of new standards and for the transposition of international standards are the following: The European Committee for, CEN; The European Committee for Electrotechnical, CENELEC; The European Telecommunication Standards Institute, ETSI. These three organisations support the policies of the EU and EFTA for free trade, worker and consumer safety, interoperability of networks, environmental protection and others, developing standards asked though mandates. Both CEN and CENELEC are made up of 31 national standards bodies recognised both at national and European level (one per country of the EU and of the European Economic Agreement). The national standards bodies constituting the membership of CEN are active in many different sectors, whereas the national standards bodies constituting the membership of CENELEC may be specific to the electro-technical sector. Therefore, the membership of CEN and CENELEC depends on each country. ETSI, differently from CEN and CENELEC, is based on direct participation of industry and other interested stakeholders standardisation The elaboration of national standards is the responsibility of national standardisation organisations. Each country sets up national "mirror committees" where all interested national stakeholders may participate (such as industry, notified bodies, universities representatives, consumers representatives, public authorities...). Participation in mirror groups depends on each national standardisation organisations rules. mirror committees develop national positions on the drafting and voting of a European standard. Those positions are then taken into account at the European Technical Committee. It is particularly important for SMEs to participate in these "mirror committees" and express their points of views. 3.2 The CEN standardisation process Standards are not drafted by Standards Bodies but by experts in the specific field covered by the standard. It is the role of the Standards Bodies to facilitate this process. The drafting of standards is undertaken in CEN TCs or Project Committees (PCs). Most of the time a TC is 12

14 divided into several working groups (WGs). Technical issues and standards details are discussed in the WG. The TC plenary meeting is held once per year to vote and decide about the work done in WG. Experts participate in the TC/PC via the Body in their country and could represent trade associations (industry), professional institutions, government, consumer bodies, academia, education bodies, customers, certification bodies... On TC plenary level experts represents their national position decided in their national committee. On WG level, each expert represents the interests of his own sponsor. Participation in CEN European Technical and Project Committees CEN / TC 1 Expert Associate Delegation Delegation Bodies Bodies Body Bodies Bodies Body Bodies Bodies Body Normapme Mirror Committees or Mirror Committees Mirror Committees Mirror Committees or SME CEN Members send a delegation to represent the common national position with the aim of reaching a consensus on a standard at European level. CEN Members are committed to ensuring a balanced representation of all interested national stakeholders when nominating delegates to TCs and PCs at European level. A TC can create working groups or project teams to carry out a specific task, for example, to provide the TC/PC with a draft standard. CEN Associates (Normapme is one of these) can participate in a TC as observers (see the following figure) and they can give their views and comments on documents but they do not have a voting right. The expert of Normapme participates at European level in order to represent the position of the Normapme Mirror Committees regarding SMEs interests. 13

15 The role, the responsibilities and rights of an Associated Member (Associate) An Associate is an organization representative, at European level, of particular social or economic interests. Its responsibilities are the following: Commits to the development and promotion of European standardization (The Statutes of CEN, Articles 6.3 and 17); Commits to comply with rules set by the Statutes of CEN, including financial obligations as decided by the General Assembly (AG), (The Statutes of CEN, Article 7.2); Keeps CEN Mirror Committees fully informed of any changes in its organization and provides any other relevant information. The rights that characterized this type of membership are: To participate, without voting rights, in the AG, open sessions of the Administrative Board (CA), Technical Board (BT), Sector Activities, and CEN Certification Board (CCB), (The Statutes of CEN, Article 6.3; Resolution AG 15/1999; Internal Regulations - Part 4, Clause B.3.2.2); As a member of the BT, to apply for and hold TC secretariats under defined conditions and upon signature of a Service Level Agreement (SLA) with CMC (Resolution CA 6/1999; AG N 562 rev; Resolution BT 15/2000); To participate in TCs and Subcommittees, upon request, as an observer (Internal Regulations - Part 2, 3.2.4); To receive documentation for all meetings for which requests for participation have been granted; To propose new work item(s) in accordance with the correct procedure provided it will support the proposed work (Internal Regulations - Part 2, Clause 11.1). Furthermore European associations have the possibility to ask for a liaison statute within a specific TC/WG/PC, and become observers. Also there are possibilities for representatives of bodies or companies from countries outside the CEN membership to participate in the CEN work. The first task of a newly created TC is to adopt a Business Plan. The main objective of the Business Plan is to provide a concise and up-to-date overview for interested stakeholders of important business, technological, environmental and social trends in the field addressed by the work of the CEN committee. In addition, the Business Plan also establishes the priorities and work plan of the TC. Project Committees do not normally need to elaborate a full Business Plan but they should establish and agree on a work programme, which will need to be formally approved by the CEN Technical Board. For more information: 14

16 3.3 The Cenelec standardisation process The CENELEC standardisation process is very close to the CEN one. One difference between CEN and CENELEC is related to the organization of the membership and of the relations with the cooperating associations. CENELEC in fact is composed of the Electrotechnical Committees of 31 European countries, and of 11 Committees from neighbouring countries participating in CENELEC work as Affiliate. Moreover many independent European or International organizations representing a sector or subsector of the electronic field are CENELEC Cooperating Organizations (as Normapme is). The role, the responsibilities and rights of a Cooperating Organisation A cooperating organization is invited to advise on current and future standards programmes (e.g. by stating needs and by proposing priorities), to propose drafts for possible incorporation in ENs through the normal approval procedures, to assist CENELEC in case of difficulties during standardization, and to deliver expert advice on legislative consequences of adopted ENs. All proposals and contributions from cooperating organizations are introduced to the CENELEC Technical Board where they are referred to the relevant (technical) body. This (technical) body may invite the cooperating organization to send a delegation (max. 3 persons) to the meeting where their contribution is handled. The possibility of permanent observership in identified technical bodies is offered against payment of a minimal annual fee. In addition, a cooperating organization may request permanent observer status in particular CENELEC technical body(ies) of concern to it. If observership is granted, and on receipt by the Central Secretariat of the appropriate annual service fee, the cooperating organization is entitled to receive all documents of the technical body(ies) and to send a delegation (maximum three persons) to all of its (their) meetings. Finally, a cooperating organization may also request permanent observer status in the CENELEC Technical Board. If granted, and upon receipt by the Central Secretariat of the appropriate annual service fee, the cooperating organization will be entitled to receive all Technical Board documents and to send one observer to each Technical Board meeting. The description of the principles and procedures for the establishment and implementation of cooperation agreements between CENELEC and organizations interested in European Electrotechnical Standardization is given in CENELEC Guide

17 Participation in CENELEC European Technical Committees CENELEC / TC 1 Expert Cooperating Organisation Delegation Delegation Bodies Bodies Body Bodies Bodies Body Bodies Bodies Body Normapme Mirror Committees or Mirror Committees Mirror Committees Mirror Committees or SME For more information: ETSI ETSI produces globally-applicable standards for ICT (Information and Communications Technologies), including fixed, mobile, radio, converged, broadcast and internet technologies. It is officially recognized by the EU as a European Standards Organization and brings together more than 700 member organizations drawn from 62 countries worldwide. Much of this work is carried out in committees and working groups composed of technical experts from the Institute's member companies and organizations. These committees are often referred to as 'Technical Bodies' (TB), and typically meet between two and six times a year. They also rely heavily on electronic communications to help progress the work, especially in-between meetings. The main technical body recognized from ETSI is the Technical Committee (TC). The TC is a semi-permanent entity organized around a number of standardisation activities addressing a specific technology area. The results of a Technical Committee's work may often be used by other Technical Bodies. 16

18 Participation in ETSI European Technical Committees/ETSI Projects ETSI / TC 1 Expert Full member Full members Consultancy Administration Research Body Research Body Full member Manufacturer Administration or Network Operator or Normapme Mirror Committees SME In ETSI TCs/ETSI Projects experts don t participate via the Body in their country but they participate themselves directly with rights that depend on the kind of membership that their organization own. The experts participating in ETSI TC could represent Manufacturer, Administration, Network operator, Research Bodies, Certification Bodies, SMEs, Consultancy This is classified in a double matrix as the type of the interests and the size of the structure. In ETSI the rights in the participation in Technical Bodies depend in the kind of membership owned. In fact in ETSI the following three types of Members can be found: Full members (NORMAPME is one of these) have the right to attend meetings of a Technical Body and to participate in the work with the right to vote; Associate members have the right to attend meetings of a Technical Body and to participate in the work with the right to vote on all matters except those related to the elaboration and approval of ENs or on matters concerning documents exclusively intended for regulatory use by the European Union. Observers do not have the right to attend the meetings of a Technical Body or to participate in the work of a Technical Body. SMEs can participate directly to the ETSI TCs/ETSI Projects if they became member of ETSI or they can participate through NORMAPME. For more information: 17

19 3.5 What are the different steps in the development of a standard? The elaboration of a new European standard can either originate: from the European Commission, through a mandate, to answer to societal needs (harmonised standard hen); from other stakeholders, via CEN members or CEN associates, to answer to market needs (EN). The technical boards of CEN, CENELEC or ETSI then sets up and monitors TCs and WGs. When a relevant international standard already exists, it is transposed; if no international standard exists, a new TC is set up. The standardisation process is meant to be inclusive for all stakeholders. Standards are developed on a voluntary basis and reflect the views of all parties and stakeholders. Inclusiveness in the European standardisation system is ensured by CEN and CENELEC through their membership of national standard bodies. During the elaboration of a European standard, national "mirror committees" are set up where all interested national stakeholders can participate (such as industry representatives, consumers representatives, public authorities...). mirror committees develop national positions on the drafting and voting of a European standard. Those positions are then taken into account at the European TC. ETSI directly involves the participation of the industry but also national votes on Harmonised European standards. The graphics below are based on CEN process, but also match the CENELEC and ETSI processes. A European standard is on the average created in 36 months, or three years. The maximum timeframe within which to develop a standard is 54 months. 18

20 Once a proposal for new work has been accepted, it is allocated to a Technical or Project Committee (TC/PC). If no existing Technical or Project Committee is competent on the subject, a new TC/PC is created. CEN documents are developed according to strict rules to ensure that they reflect the values of openness, transparency and consensus. The specific steps will vary slightly depending on whether the document to be developed is a European Standard or a Technical Specification/Technical Report. Development of a European Standard (EN) The TC/PC will elaborate a draft standard. To allow rapid progress in drafting, a smaller group of experts (working group) can be created by the TC/PC. Once the draft is ready a public consultation (enquiry) will take place. This is a key stage in the process of ensuring transparency and acceptability of the standard. The comments received during the public consultation will then be examined by the TC/PC and the draft will be amended in line with the decisions made by the TC/PC. A report of this process will be carried out and will include justification for comments not taken up. The final draft, once modified, is sent for formal vote. This is a weighted vote of all national standardisation bodies that are member of CEN. Further information: Enquiry process Formal vote of a European Standard (EN) 19

21 3.5.1 How long does it take to develop a standard? In order to develop standards within acceptable timeframes according to market needs and, at the same time, to guarantee sufficient time for consultation and consensus building, European Standards (ENs) are developed in a maximum timeframe of 3 years. The graphics below show in detail the time allocated for every step in the development of ENs. Timeframe for the development of European standards (ENs) 20

22 4 The expert and NORMAPME 4.1 What are the NORMAPME Mirror Committees? Whenever NORMAPME appoints an expert in a standardisation TC, this person is supported by the related NORMAPME Mirror Committee. The role of the Mirror Committee is to form positions on the issues debated in the corresponding TC. The positions expressed by the NORMAPME expert in a TC are the result of an open and consensus based consultation of the European members of the corresponding Mirror Committee. The expert is responsible to create and/or animate a NORMAPME working group covering the Committee s area of interest. This includes activities such as the preparation of meetings of the working group including its agenda, chairing of the meetings and the drafting of the minutes. In addition, this will include exchanges (with the members of the working group) of all the official documents of the Committee, as well as other relevant documents, such as positions of NORMAPME members and other SME standardisation experts and where required an electronic vote of the working group members on common NORMAPME positions. Moreover: The participation in NORMAPME Mirror Committees is voluntary. NORMAPME does not pay any compensation for the participation in Mirror Committees. The work of Mirror Committees is exclusively done via electronic correspondence (unless the participants agree differently). 4.2 Who can participate in NORMAPME Mirror Committees? The experts appointed in NORMAPME Mirror Committees are persons with relevant knowledge of the matters subject to standardisation in the corresponding TC. The experts are appointed by SME associations or SME undertakings, whether they belong to NORMAPME membership or not. The experts of Mirror Committees can express the opinion of their association or organization but are also invited to freely present their personal views based on their own experience and knowledge. 4.3 The relations of the Experts with the staff and the Secretariat of NORMAPME The expert is continuously supported by the NORMAPME secretariat. One of the staff members is the direct contact for the expert. 21

23 First, the relationship between expert and secretariat is based on open communication and frequent contacts by , phone or meeting Expert and Technical Committee The expert is participating in the meetings of TCs and other related committees (1 or 2 per annum). In order to prepare these meetings and to report the decisions, the expert writes two kinds of official reports and submits them to the secretariat: 1 Action plan per year. It describes the objectives and strategies for the coming year. Quarterly reports per year - This report details the developments of the standardisation work of the committee with focus on issues which will impact SMEs. The report is based on information such as the documents that have been circulated by the Committee secretariat, the positions expressed by influential stakeholders, the exchanges with the NORMAPME working group and any other privileged information NORMAPME services In addition to the regular information exchange, NORMAPME secretariat is collecting information from the TCs, contacting the TCs secretariat and convenor when relevant, providing guidance on standardisation procedures and functioning of the European institutions and legislation. Twice per year the expert is invited to attend a NORMAPME experts meeting. The aim is that all NORMAPME experts meet and exchange about their role, their success, their difficulties and good practices. 4.4 The Livelink The Livelink is an extranet for online document management and collaboration environment. It supports the work of committee members in the process of standards development. Each member of a TC/WG has access to all the documents related to this TC/WG. It is the key system to have the information. Online meetings, discussion forums may be available depending on the TC/WG. Aside from the member-only areas, there is a site which allows general access to documents that have been placed in the public domain. Each TC/WG space is moderated by the national standardisation body in charge of the TC/WG secretariat. Login and password have to be asked as soon as the expert s nomination is done. 22

24 Useful links References CEN Hands on standardization: a starter guide to standardization for experts in CEN Technical Bodies January 2009 CENELEC - Primer on Standards: Uncovering the mysteries of standardization in Europe. NORMAPME European standardization and CE marking for SMEs Websites: Enclosed documents CENELEC Guide n 14: The concept of Cooperation Ag reements CEN/CENELEC Guide 17: Guidance for writing standards taking into account account micro, small and medium-sized enterprises (SMEs) needs ETSI Directives - Version 27- May