UEAPME - SME FIT II. Training Tool Standardisation and Certification. by Karine Iffour NORMAPME

Transcription

1 PHARE Business Support Programme III of the European Union for Bulgaria, Croatia, Romania, Turkey UEAPME - SME FIT II Training Tool Standardisation and Certification by Karine Iffour NORMAPME This project is funded by the European Union under the PHARE Business Support Programme and implemented by UEAPME and its partners. The content of this document does not necessarily reflect the opinion of the European Commission.

2 TABLE OF CONTENTS Introduction PART I - Brief description of the relevant EU laws I/ Standardisation II/ Certification PART II - Consequences for SMEs I/ Standardisation A) Benefits 1) Importance of standards for companies 2) What are the business benefits of standards? a) Standards supporting regulation b) Cost c) Revenue and market access d) Opportunity 3) SME interests in applying standards, and in participating to standardisation process. a) Why should SMEs use standards? b) Standard benefits in practice B) Problems for SME 1) Application a) Information Sources b) Information Content c) Application within the SME 2) Participation in standardisation II/ Certification PART III - Strategies for application I/ Standardisation A) How to take part in standardisation? B) How to find the relevant standard? C) How to obtain a standard? II/ Certification 2

3 Introduction A standard is a document, agreed by consensus and approved by a recognized standard body. In Europe, those bodies are CEN, CENELEC and ETSI. This document provides rules, guidelines or characteristics for products, activities or their results. It aims at the achievement of the optimum degree of order in a market. There are standards of various types: basic standard, terminology standard, testing standard, product standard, etc They are made by a process called standardization, with the participation of (all) interested groups. Most of standards in Europe are European standards. The share of international ones is constantly increasing as there are hardly any National standards being developed at National level. European standards played a major role in building the EU's Internal Market, by helping to remove the technical barriers to trade created by disparities among national standards. The uniform use of European standards throughout the EU and the European Economic Area eliminates a multitude of different national technical blueprints and related testing and certification requirements. Businesses want common standards to reduce the cost of purchasing parts and components and ensure that networks remain interoperable. Standards help the market to create an effective trading language and the associated tests and certificates are often seen as a way to build trust and confidence between trade partners. Certification 1 (of conformity) aims at proving, through a certificate, a marking or a label, the conformity to a referential system. It applies to products, services, organisations and persons. The conformity is assessed according to several types of referential systems: standards, specifications or technical rules, a schedule of conditions, norms, levels of competences. According to different cases, different techniques are used according to the chosen referential systems: tests, audits, inspections, exams... The certification may be imposed by regulation (regulatory certification), or can be chosen by the manufacturers themselves, mostly for commercial reasons (voluntary certification). PART I - Brief description of the relevant EU laws I/ Standardisation European standardisation policy is based on some legal documents: Directive 98/34, Directive 98/48/EC, Council Resolution of 7th May Directive 98/34/EC of the European Parliament and of the Council of 22nd June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations. Directive 98/48/EC of the European Parliament and of the Council of 20th July 1998 amend Directive 98/34/EC. Council Resolution of 7 May 1985 is on the new approach to technical harmonization and standards. Directive 98/34/EC is expected to be revised in Standardisation is an integral part of the EU to achieve the Lisbon goals by carrying out better regulation and by simplifying legislation, by increasing competitiveness between enterprises and by removing barriers of trade at international level. 1 Additional information on certification and CE marking can be found in the training tool Product Safety-WKÖ 3

4 On 18th October 2004, the Commission adopted a Communication on the Role of European Standardisation in the Framework of European Policies and Legislation accompanied by a staff working paper dealing with the challenges for European Standardisation. Both documents analyse the current situation of European standardisation and identify the key areas where the European standardisation system and the instruments available to European standardisation policy can and should be further improved. Both documents are a response to the Council Conclusions of March 2002 and the Council Resolution of October 1999 on the Role of Standardisation in Europe in which the Council had acknowledged the important role of standards and invited the Commission to analyse the current situation of European standardisation and to respond to the challenges the European standards system is faced with. The final output of this process was the European Standardisation Action Plan in October 2005 that was revised in Alongside, the European Commission has released a report on the Operation of Directive 98/34/EC from 2002 to In its Conclusions of December 2004 on European Standardisation, the Council has acknowledged the Commission s findings and invited the Commission to pursue the activities proposed in the Communication and in the staff working paper. On the 24 th of 2006, a decision of the European Parliament was adopted on the financing of European standardisation. Requests for European standards work can come either from the private or public sector. The rules of procedures to decide whether or not a project will be pursued and, if so, how it should be dealt with, vary according to the standardisation body. Standards are elaborated by Technical Committees in line with the WTO Code of the Good Practice for the Preparation, Adoption and Application of Standards. Besides this code, European standardisation is based on the four following pillars: - Standstill: it is an obligation accepted by the EAA countries to stop the elaboration of a national standard, either during the preparation of a European Standard or after its approval, which could prejudice the harmonisation intended. - Weighted voting - Implementation: The countries shall implement the European standards as national standards (usually within 6 months after the approval). - Withdrawal of conflicting standards Although international trade within the EU is mainly represented by intra community trade, relations between European and International standards appeared quickly as a necessity. Therefore two agreements have been signed laying down the principles for the cooperation between the European and international standards bodies. The Vienna Agreement regulates cooperation between CEN and ISO and the Dresden Agreement the cooperation between CENELEC and IEC. The aim is to achieve a general exchange of information, participation in standardization projects. Above all they adopt international standards into the European system without any amendment. 4

5 The task of framing standards that provide technical solutions for manufacturers seeking to comply with EU - directives is assigned by the European Commission to the European standardisation bodies. These standardisation assignments (Mandates) state guidelines within which standards need to be framed to meet each directive s essential requirements. All new approach directive standards must be based on sound scientific knowledge, fit for purpose, mutually consistent and rapidly modifiable to keep pace with technological innovation. Once a harmonised standard becomes available, a manufacturer can declare that his product conforms to this standard and therefore national authorities presume that his goods comply with the directive s essential requirements. These goods can thus be placed on the market based on the manufacturer s declaration and with a simple certification procedure. Nevertheless, the flexibility of the new approach also allows manufacturers to use mechanisms other than applying harmonised standards to demonstrate conformity with a directive, thus providing an incentive to innovation. EU directives specify only essential requirements to ensure a high level of protection (health, safety, consumers, environment, etc.). Essential requirements worded so as to produce binding obligations that can be uniformly enforced by Member States. Directives deal with large families of products and/or hazards. Commission mandates European standardisation bodies to define the detailed technical solutions (harmonised standards), which manufacturers may apply on a voluntary basis. Manufacturers may choose whether they apply these harmonised standards (or other technical specifications), provided their products satisfy essential requirements. Where harmonised standards are complied with, a product is presumed to meet essential requirements (manufacturers are no longer required to obtain prior third party certification). However, manufacturers are legally responsible for ensuring that all products placed on the market comply with the directives. Member States must ensure that nonconforming products are withdrawn from the market (market surveillance). Directives also lay down conformity assessment procedures for evaluating compliance with the directives, taking into account identified potential risks. Conformity assessment is carried out by testing and certification bodies ( notified bodies ), designated by Member States within their jurisdictions and acting under their responsibility. CE mark symbolises conformity with all relevant Community rules Member States recognise that a CE marked product placed on the market anywhere in the Community complies with their own national laws. New Approach directives are based on the following principles: * Harmonisation is limited to essential requirements. * Only products fulfilling the essential requirements may be placed on the market and put into service. * Harmonised standards, the reference numbers of which have been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements. * Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements. * Manufacturers may choose between different conformity assessments procedures provided for in the applicable directive. 5

6 II/ Certification Conformity assessment plays an important role in most technical regulations. While conformity assessment procedures can contribute to achieve essential public policy objectives, they can also act as an important source of technical barriers to trade. The European Community has therefore felt the need to develop a policy in the field of conformity assessment. This has to balance the need to guarantee the free movement of goods within its internal market with the requirement to ensure a high level of protection concerning health, safety, environmental protection and consumer protection. This policy became known as the Global Approach. The traditional method of drawing up Community technical harmonization directives provided for the recognition of certificates of conformity issued under the sole responsibility of the national competent authorities. This often led Member States to delegate the technical work to entities unknown to the other Member States or the Commission. These bodies were designated on the basis of unspecified criteria. The experience from this approach highlighted one of the main problems, namely the lack of adequate information concerning the operation and competence of the bodies involved, as well as lack of means for demonstrating their competence. The Global Approach therefore relied on the definition of objective criteria underpinning the designation of conformity assessment bodies). The primary objective of the Global Approach is to introduce transparency into the conformity assessment systems used in both the regulated and non-regulated voluntary sectors. One of the main means to achieve this is to ensure that the competence and credibility of conformity assessment bodies can be objectively verified. This is intended to generate confidence and thus promote the mutual recognition and acceptance of the results (test reports, certificates, etc.) issued by these bodies. The two main tools foreseen by the Global Approach are the use of standards and accreditation as the preferred means to demonstrate the competence of conformity assessment bodies. The Global Approach in certification and testing in Europe is to complete the New Approach to European regulation, which was introduced ten years earlier. (Same goal: technical harmonisation!). It came into force on January 1, In the field of regulation, the Global Approach aims at: defining the different methods for assessing the conformity with the basic requirements of the New Approach Directives (Council decision 93/465/CEE of 22/07/93), harmonising these Directives regarding marking (graphic design, signification, definition of responsibilities, sanctions, etc.). Eight modules (from A to H), with different levels of complexity and requirements exhaustively define the different controls and tests that apply to products and their manufacturing processes before they enter the market. In this toolbox, each New Approach Directive indicates the appropriate modules for the assessment and attestation of conformity with the basic requirements, considering the product and related risks. Conditions for reliable conformity assessment are necessary. The key elements in this respect are the building of confidence through competence and transparency, and the setting up of a comprehensive policy and framework for conformity assessment. The Council Resolution of 1989 on the Global Approach to certification and testing states the following guiding principles for Community policy on conformity assessment: 6

7 * A consistent approach is developed in Community legislation by devising modules for the various phases of conformity assessment procedures, and by laying down criteria for the use of these procedures, for the designation of bodies operating these procedures, and for the use of the CE marking. * The use of European standards relating to quality assurance (EN ISO 9000 series), and to the requirements to be fulfilled by conformity assessment bodies operating quality assurance (EN series) is generalised. Setting up of accreditation systems and assurance (EN series) is generalised. * Setting up of accreditation systems and the use of inter-comparison techniques are promoted in Member States and at Community level. * Mutual recognition agreements concerning testing and certification in the non regulatory sphere are promoted. * The differences of existing quality infrastructures (such as calibration and metrology systems, testing laboratories, certification and inspection bodies, and accreditation bodies) between Member States and between industrial sectors are minimised by programmes. * International trade between the Community and third countries is promoted by means of mutual recognition agreements, cooperation and technical assistance programmes. The New Approach entailed refining conformity assessment in such a way as to allow the Community legislator to evaluate the consequences of the utilisation of different conformity assessment mechanisms. The objective was to provide flexibility of conformity assessment over the entire manufacturing process in order for it to be adapted to the needs of each individual operation. PART II - Consequences for SMEs I/ Standardisation Although standards are often burdensome, the benefits of standard implementation are undisputable as it will be demonstrated below. It is also true that misfit standards for SMEs can be very damageable for their business. Hence, their participation in standardisation process is crucial. But as they lack of resources, their participation needs to be supported. A) Benefits 1) Importance of standards for companies Within the company: Not reinventing the wheel oneself, but using existing solutions (laid down in standards) which have already been well thought out. 7

8 To the outside: Bringing one's own procedure into line with what is normal elsewhere, so that cooperation is simpler and purchasing cheaper. Efficient working, by repeatedly using the same solution. Using recognised requirements in the field of for example quality and safety as a criterion. Being able to bring products onto the market, because they meet requirements (laid down in standards) that are important in that market (and also meet the statutory requirements). Being successful with products, because they meet customers' wishes. Giving clients confidence: the product (and/or the production method) meets accepted requirements. 2) What are the business benefits of standards? The business benefits of standards can be grouped under four generic headings. Regulation Cost effective compliance Customer assurance Reduce product liability Risk management Governance Cost Optimisation Reduced transaction costs Product / process interoperability Flexibility in supply chain Best practice & management systems Maximising Revenue Improve speed to market Product acceptance Product life cycle management Business Opportunities Develop new markets & future sales Influence technology change Influence industry evolution Structure regional / international competition 8

9 a) Standards supporting regulation Cost effective compliance Many standards are associated with regulatory requirements and legislation. Legally, standards do not in themselves impose any obligations of adherence. However, regulations may allow presumption of conformity for products complying with certain standards. This enables regulation to be kept simple, while still enabling both standard and innovative products to demonstrate compliance. In some markets, standards may be directly referenced in regulation, and contract terms may also insist on compliance with a standard. Compliance with standards enables manufacturers to demonstrate the suitability of their own technology, providing them with greater flexibility. Customer assurance & reduced product liability Safety and other standards help reassure customers that the product is safe, reliable and high quality, even though the manufacturer and the product itself may be unknown to the customers. This increases product acceptance and the overall size of the market. Other standards have similar effect on product credibility and acceptability. Standards provide a common language for units and test methods, and accepted communication methods that demonstrate the firm s commitment to health, safety and environmental rules. Showing that the product conforms to accepted safety and other standards may reduce liability for product defects. Risk Management Standards may acquire legal standing by being referenced, directly or indirectly, in trade descriptions, contracts and regulations. In particular, formal consensus standards are privileged documents for legislation, which may include antitrust protection. Firms may reduce their risk from legal actions, including competition policy, by use of standards. Governance Process standards help define internal procedures for organisations. Adhering to such standards is often a requirement when bidding for contracts, particularly in the public procurement arena. b) Cost Reduced transaction costs Products adhering to a set standard are able to demonstrate quality and reliability, which in turn inspires trust and confidence. When procuring a component, product or service, a buyer need only refer to that standard, rather than sifting specifications from different suppliers and undertaking separate quality and performance checks. 9

10 Standards serve to simplify component specifications, reduce variety for economies of scale, reduce warehousing needs (JIT), and enable easier maintenance and support. The producer of standard products similarly saves the effort of specifying product performance and demonstrating reliability. It only needs to show conformance to the standard, which can be demonstrated by conformity declaration. 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 PC computers by designing and manufacturing to a standard, it is possible to ensure at least a basic level of interoperability with products from other manufacturers. This saves redesigning the product for each new system that it needs to work with. By adhering to interoperable standards the potential marketplace for a product is increased, improving the opportunity to benefit from economies of scale. Interconnectivity standards cover cases where a product depends on its ability physically to connect with another part of a system. 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 to make use of the knowledge and experience of experts in management, rather than undergo the time, cost and uncertainty of developing their own protocols from scratch. They record proven solutions of experts who have faced similar challenges. In addition to improving internal performance and cutting costs, process standards help to communicate and spread best practice. c) Revenue and market access Improve speed to market Introducing a product into a market where the standard is already established often results in a greater acceptance and faster take-up of the product. Also, it is easier to focus attention on differentiating features of a product and to gain acceptance of novel ones if the product conforms to the accepted standard. Product acceptance Often, the marketability of a product is fully dependent on conformity with local standards and regulation, including health, safety and environmental rules. This especially affects entry to international markets, where local regulations and / or standards must be met before selling into a foreign market. 10

11 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 strategy. Basic standards for performance and safety help convince early adopters to accept the product. Further growth is likely to be accompanied by cost reduction, which switches further emphasis on standards for common product design and standardised components. d) Opportunity Develop new markets Standards can help to define the design of a new product, ensure it is compatible with other products on the market and help establish a new product in the market. Conforming to known standards helps to establish the credibility of a new product. Entry to new markets whether national, regional and / or international is frequently dependent on meeting certain health, safety or environment criteria, which standards can help to demonstrate. Once established, standards are enduring and help to ensure future sales. Suppliers and markets build up around accepted standards, which then provide a basis for further development of the standard and technology, adding to longevity. In advanced technologies, incorporating details of the properties of new materials etc in a standard can create a market where none would otherwise exist. Influence 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 for providing the basis for development of complementary products and services that interface with the core product. Similarly, standards can influence the development of an entire industry, whether it is a fragmented market based on proprietary standards and customised products or one based on standardised large volume products with multiple suppliers, including sub-markets for complementary products and services. Securing influence over evolving technical standards can create major competitive advantage. Structure of Regional / International Competition Markets are increasingly international, reflecting the globalisation of the world economy. Regional and international standards assist globalisation by making it easier to enter international markets by conforming to the relevant standard. They increase market access and prevent barriers to trade by demonstrating the local requirements are met. Essentially, harmonised standards increase the opportunity for firms to sell internationally. 11

12 3) SME interests in applying standards, and in participating to standardisation process. When standards issues are raised among SMEs, two questions appear immediately: Why? And How? If we analyse the results of the European network of small business researchers survey on SMEs, approximately 60 % of SMEs agree that standards and standardisation are very important issues, standards application remains a headache for SMEs. If large companies have the internal human and financial resources to get and apply relevant national, European and international standards, it is a completely different story for SMEs. Both questions require explanations on why SMEs should use standards and how they can apply them in their structure. a) Why should SMEs use standards? Before investigating the benefits of standards and mainly when SMEs are concerned, we should consider the fact that standards perception and benefits are seen differently according European countries. If in a KAN survey, in 2000, 57% SMEs declare using European standards and 43% - international standards, the interest in the issue varies widely according countries. In Ireland 90% of the SME, having responded to the survey initiated by the Commission, agreed that standards and standardisation were very important issues, however in Germany out of those who responded only 40% agreed. Country differences do exist also when we consider environmental standards. Available national Data for ISO in some countries shows that the percentage of certified SMEs varies from 80% in Switzerland to 36% and 25 % in Sweden and Great Britain. Another variation of standard interest within SMEs depends on the activity. Importance is also related to export activities, and the more an SME will export the more standard issues will be of importance. As a matter of fact complying with standards is a safe way to have your product CE marked. CE marking is a product & services European market passport and says the product follows the essential requirements of the Directive. To get this marking, the producer has to declare that its product conforms. But Directives under the new approach are very general and hence a declaration of conformity is not safe for either the producer or the customer. In this sense, as standards are made under the Directive requirement, use of standards is an easy and safe way to follow essential requirements of the Directive. In addition to these points the use of standards can be of great benefit for all, specifically for SMEs. b) Standard benefits in practice SME managers are down to earth and rely more on experience than on believes with no proof. We provide examples where standard application has had extremely positive effects on the business. We will consider 3 types of standards: 12

13 Product & services standards QMS standards Environment standards Product & Service standards Standard benefits exist for all stakeholders, including SMEs. Let s mention once more the main ones are the following ones: - Simplification of the growing variety of products and procedures in human life. - Variety control and efficient use of materials, energy and human resources. - Compatibility and interchange ability communication - Safety, health and protection of life and the environment - Reduction of the degree of market uncertainty. - Protection of consumers and community interests - Fitness for purpose - Elimination of trade barrier. - Protect the supplier and the user by clear definition of the requirement in case of legal dispute (Directive 85/374/CEE). In the context of SMEs, standards allow small and medium sized enterprises to compete fairly with large enterprises as they can sell on the same level as them by using the standard. Use of standards in trans-border trade is essential, and considering the evolution of international contacts for SMEs it becomes crucial for them. About one third of all SMEs report an increasing number of international business contacts over the last 5 years, ranging from 30% for micro enterprises to 50% for medium sized enterprises. The importance of using the same standards as large companies is confirmed by the competition perception of SMEs. Most of them consider competition is mainly based on customer services and product quality, as price is only ranked third. Although price is not the major factor in competition, cost reduction cannot be neglected. And we have to point out the fact that good use of standards reduces cost of operation; and this reduction is even more striking when Quality Systems standards are concerned. This cost reduction applies in many sectors: - Less product / process variation - Reduced risk in exports, in supply to large customers 13

14 - Legal protection - Less rejects - Increased efficiency. Quality Management System standards Nevertheless, whatever the advantages of using standards are, it is noticed that SME use firstly standards to satisfy their Quality Management System demands, when they do have one. Anyhow, Quality Management Systems are somehow a bulk of standards made to achieve product and service quality and more and more now it is management quality which means involving more and more factors. Advantage for SMEs in using Quality Management systems are important and numerous. They can be listed as such: Might be costly but there are ways to avoid these costs by working together More efficient management system Better quality products No cost for return of defect products Legal protection. Obey European Directives More market shares Image benefit Strategic tool leading to sustainable development. Corporate Social Responsibility is a new important part in the most recent quality systems. This part of the standard can lead to tangible benefits for SMEs. They identify two main ones. First it is the improvement of the loyalty of the customer, and second it is better relations with the general community/public authorities. Environment standards Environment standards are playing a role more and more important according to the place that environment issues have in our society, where the client is increasingly a citizen rather than a consumer. Meanwhile, and from an enterprise size perspective, SMEs are taking an increased interest in formal environment management systems, mainly due to the market pressure from customers through the supply chain (especially as far as ISO is concerned). According to several recent estimations, only 18% of EMAS registrations in the EU correspond to SMEs, although important variations may exist within different EU countries. 14

15 Empirical evidence from Spain also illustrates the existing relationships between enterprise size and availability of a general environment management system. Thus, only 4.2% of enterprise with less than 50 employees has an environmental management system in comparison to 10% and 16 % amongst those enterprises with 50 to 100 employees and those with 101 to 250 employees, respectively. Generally, the existing business literature identifies a number of benefits obtained by those SMEs who effectively adopt an environmental management system. These benefits can be differentiated according to their internal and external nature: Internal benefits can be grouped in three main sub-categories: Organisational benefits basically derived from improvements in the quality of management, improved quality of environmental information, compliance with existing environmental regulations or improvement in the procedures. Financial benefits, such as cost savings from material, energy and waste reductions and efficiencies, which results in improved economic performance. Benefits on the internal employees, such as increased employee motivation and morale, enhanced employees skills and qualifications or a better company image among employees. External benefits again can be grouped in several sub-categories: Commercial benefits, such as new customers/business opportunities, preferred supplier status, clear environmental profile contributing to competitive/marketing advantage or satisfaction of existing customers. Environmental benefits, basically derived from improved environmental performance, increased energy/material efficiencies and recycling and reduced pollution Communication benefits, such as positive enterprise s public image, better relationships with customers, better access to capital from environmentallysensitive investors or improved co-operation and relationships with regulators and administrative bodies that contributes to reduce regulatory oversight. Generalities The benefit of standardization lies essentially in the integration of market requirements and reduction of costs. The savings potential through standardization is generally divided into the following divisions: 15

16 SME, which use standards: Are more profitable - Lowering of transaction costs: - Achieving economies of scale - Reduction of external effects (environmental impact) Gain closer contact with large-scale enterprises Export more Can more easily be convinced to use quality management systems Are ready for the next phase (environment, aspects of adhesion, development of the e-business) If SMEs can get advantages from using standards, they can have some problems by not using them or ignoring them. Standards can be very costly for SMEs if not understood. They can be used as a basis for contracts or exports but if ignored by the small business this may result in faulty products leading to a legal dispute. Standards can be a burden if SME are not informed and protected. But the natural tendency of many micro enterprises is to ignore them unless competition, clients or authorities force the issue. Not using standards can exclude SMEs from market opportunities like exports, but using them is equally important in daily business practice. Whatever the interests for SMEs in using standards, micro enterprises are often reluctant to do so, when they are aware that standards (and which ones) exist in their sector. This situation is mainly due to difficulties in standard application. B) Problems for SME 1) Application One of the biggest problems regarding standards and standardisation is sourcing information on standards, and mainly the ones that have to be met. It seems that SMEs which are the most concerned by the standard difficulties are the ones between employees, as the smaller ones feel less concerned and the bigger ones are more informed and structured. Standard application problems are numerous but it seems that getting relevant and useful information is the most important. Hence, we will pay special attention to this one. 16

17 a) Information Sources Even if SMEs consider it is easy to get a standard, they often find hard to find out what standards are relevant for them. SMEs often lack knowledge concerning information sources and do not know where they could find standards. Only 40% of SMEs agree in receiving relevant information on standards and standardisation, as 55% of them disagree. If the result is not affected by age or sector, it is according to size and country. 55% of micro enterprises believe in not receiving the relevant information in this matter that is quite important as most of SMEs are micro enterprises - ; and if in Finland, Lithuania and Iceland over 50% of SMEs are satisfied with the information they have, in other countries it drops to 30% (European Commission survey - 08/05/2003). Across Europe 50% of SMEs declare receiving information on standards by their craft & trade association, and only 25-30% (mainly medium sized enterprises) from NSO. The proportion of information sources is different depending on country. This difference can be explained by the difference of SME representation in member states. b) Information Content What SMEs need more is to be kept informed by getting information on standards according to their specialities and activities. 90% of SMEs would want unlimited number of follow-up inquiries at low cost, 90% would want the information to be converted more to their needs, 89% would like better search possibilities on content, 83% would like to get information on withdrawn standards and 81% would like to get comments on standard application. The content of a standard is also part of information and should be improved to make it more users friendly. As a matter of fact, SMEs ask for standards that would be comprehensive and clearly arranged, containing clear requirements with instruction for implementing them and a concrete solution. Standards should repeat full text parts from other standards instead of just referring to them. 80% demand industry-specific information for the interpretation of product-related standards of the federations, chambers and similar organizations, 77% prefer the federations as the first source of information, and under 50% of the asked ones with the search for information first of all national standardization committees would contact. c) Application within the SME The first problem and not the least is the lack of standard benefit understanding by SMEs. Micro companies use standards when they are imposed by law or regulation, the client demands it, they want to export, they are in high tech, the competition forces them. This means it is not a voluntary behaviour most of the time but a forced one, and hence there is a lack of real involvement and interest from the beginning. This misapplication is also due to a lack of human resources and funds - the lack of expertise, the very high cost per employee. 17

18 2) Participation in standardisation All stakeholders interested in the draft standard are entitled to participate, but only representatives of national standardisation bodies have the right to vote in the Technical Committee (a group responsible for development and drafting of standards which are then ratified by European Standards Organisations). Committees comprise experts who are familiar with the area being studied. Members provide inputs and feedback based on their professional knowledge and experience. Often SMEs consider standards as a burden, made by large groups for large groups; and think they are not concerned. It is commonly due to some standards' imperfections. SMEs would advise that standards should: Be comprehensible and clearly arranged, Contain instruction for implementing the standards and concrete technical solutions (instead of general concepts), Repeat excerpts from other standards instead of merely referring to them. Although standard buying costs are rather low, the cost devoted to exploit specific standards, to audit internally and to be verified externally, is considered rather high. ¾ of company respondents would like to know if they comply with standards. Normapme, as a SME representative in standardisation, thinks that awareness campaigns should be lead, experts from SME associations should be trained and sectoral and country specific technical guides written in the local trade language should be prepared. If standard implementation has to be promoted among SMEs, their participation in European standardisation work has to be done too. SME participation in standardisation must be promoted as standards can be very costly for SMEs if designed for the large company only and if they are too complicated to use effectively in SME. Once we have identified problems faced by SMEs as far as standards and standardisation is concerned, some ideas are developed in order to increase implementation of standards in SMEs and SME participation in standardisation and they can be listed as follow: Intensive information campaign by newsletter, website, public announcements, visits & lectures Help in issuing of adapted standards, of guide of good practice and manuals in every day languages. Spread the effective use of such standards Europe wide. Participation with experts of small enterprises in standards committees 18

19 Training on standards and quality Technical assistance to set up shared standard and quality centre by sector and region. II/ Certification Since January 1996, the CE mark must appear on all products covered by the European New Approach Directives. (You have no choice!). The marking is a passport that controls the access of products European or others to the Single Market. It attests conformity with the basic requirements concerning health, safety but nothing more. The product is not dangerous (in principle), but the marking does not necessarily mean that the product is reliable or functioning. On the increasingly competitive market, it is voluntary quality markings generally national ones, like in France that may influence the customers choice. In fact, these markings are only authorized if the marking leads to higher added value (by surpassing the basic requirements of the Directives). The marking is applied by the manufacturer himself and in general under his own responsibility. For certain products however, according to the risks implied, the directives require that proofs of conformity (tests, controls of production and of the quality system ) are delivered by bodies whose competence is recognized by the Member states: the notified bodies. In the Official Journal of the European Communities (OJEC), the Commission publishes a list of the notified bodies for each directive. The manufacturer can choose any body from the list. Whilst CE marking provides a product s passport and enables it to have free movement within the Internal Market, the same cannot necessarily be said of any voluntary certification that the product has been awarded. There are several thousand certification bodies in Europe. Many operate marking schemes. In the absence of mutual recognition arrangements, certification of the same product may need to be repeated in several countries. Or, if a certificate is accepted in another country, it may still be necessary to pay extra licence fees for the affixing of equivalent mark in that country. Manufacturers have their own reasons for requiring certification and marks: - As a requirement of their quality management policy which is to have their in-house testing double checked; - If the manufacturer does not have in-house testing facilities, the test certificate can be used as part of the technical documentation required by legislation before affixing the CE marking. Certification and marks are most consistently used by manufacturers supplying consumer products. The main reason they gave for seeking certification was to comply with their quality management policies. Typically, where manufacturers have in-house testing facilities, they still require a second independent opinion of the quality of the product to ensure it complies 19

20 with the applicable legislation. The underlying reason being to safeguard their corporate and brand reputations for supplying trustworthy products. Where manufacturers do not have in-house testing facilities and they need to make a declaration of conformity in order to place CE marking on their product, they require a test report for the product. This report forms part of the technical documentation that must be established and held on file by the manufacturer as part of the requirements enabling CE marking. Testing a product forms part of the certification process, so when certification is required, it can provide manufactures with both a test report and an independent opinion of the quality of the product. There were other reasons given by manufacturers for affixing marks. Firstly, the mark may be required for specific marketing purposes, because a buyer is demanding it or because in some product sectors it needs to be easily spotted by buyers. Secondly, the mark (or more specifically the certification that led to the mark) is required since, through mutual recognition arrangements, it could be used to enable access of that product to markets outside Europe where marking is mandatory e.g. Russia. SMEs, needing to establish a brand reputation, may use marks to build trust in their brands. Brands already established at the European level do not have these particular requirements for marks. Therefore, multiple certification with or without marks, can amount to a barrier to trade for SMEs. Although a number of the major manufacturers of consumer products with well known brand names continue to use voluntary certification they do not always affix the mark to the product. They say that the addition of marks offers little marketing advantage as their brand name already has a high level of trust in the market place. Trust in a product is very important in a competitive market place. Large manufacturers with established reputations already have it but new entrants to the market, often SMEs, have no established (trustworthy) reputation and may seek certification and marking as a way to demonstrate that their products can be trusted. New entrants/smes are thus faced with costs for voluntary certifications and markings that larger established companies can avoid. Where a lack of mutual recognition leads to requirements for repeated certification in a number of European countries, as reported by manufacturers of security alarm systems, the expenses for multiple certifications can become so high that they effectively act as barriers to trade. If conformity is valuable and CE marking a European market passport, certification is a more complex issue as: 1- It can be or not compulsory need identification - can be hard to make 2- The quality of the certification body are different 3- The certification value for money is not easy to determine. 20

21 1. According to a KAN survey, a large percentage of SMEs would like to be better informed on the standards they have to be conformed with. This trend is also valid concerning certification and when it is compulsory. In order to find out, they have to know which Directive (s) applies to their product and the meaning of the conformity module they have to use. It is quite complex. 2. The quality of certification body is a big issue, mainly due to the fact it is a commercial activity. For instance, in September 2002, some certification bodies were issuing a large percentage of ISO 9000 series: 1994 certificates although this standard will not be valid anymore after December SMEs manager are not always aware of standard changes and can be an easy prey for indelicate certification companies. 3. Most certification issued are relating to Quality management Systems and advantages to be conformed to this types of systems can be listed as follow: More efficient management system. Better quality products No cost for return of defect products Legal protection. Obey European Directives More market shares Image benefit Strategic tool leading to sustainable development. But as it might be hard and expensive to implement, and often means trusting consultants they are not able to check out their work quality, the SME manager does not identify clearly the benefits (listed above) for his/her company. PART III - Strategies for application I/ Standardisation Standards are in principle applicable on a voluntary basis but give presumption of conformity to the relevant regulation. Nevertheless national law can use a standard as reference. A) How to take part in standardisation? Standardisation is a voluntary process based on consensus amongst different economic actors (industry, consumers, workers, public authorities, etc). It is carried out by independent standardisation bodies, acting at national, European and international level. SMEs can influence European and International standards by: taking part in National standardisation technical committees directly or/and via their organisations, taking part in European or/and International technical committees 21

22 taking part in the public consultations that are organised by National standardisation Organisation prior formal vote procedure, informing NORMAPME via their national trade organisation on the problems they meet in relation with standards. Taking part in NORMAPME mirror committees Commenting on NORMAPME consultation B) How to find the relevant standard? At European level, electro technical standards are developed by CENELEC, telecommunication standards by ETSI and other sector standards by CEN. At international level, the respective standardisation bodies are IEC, ITU and ISO. Each of the National Standardisation Bodies offers an electronic search engine for the standards that are valid in a particular country. You can go directly to the main website of a NSB of your interest and follow the instructions how to find a standard. Some of the NSBs offer abstracts of selected standards, so in case you are not sure if the standard is the right one, it is sometimes worth visiting the website of other NSBs to get some more information. All European standards can be found on the national level. These standards are simply preceded by letters EN. You can also buy them through the national websites. In addition CEN, CENELEC and ETSI offer their own search engines. However, all three organisations have a slightly different system one has to get used to (see NORMAPME PowerPoint presentation). Besides, European Standardisation Bodies provide also information on the drafts of standards and new work items. Similarly, all three International Standardisation Bodies i.e. ISO, IEC or ITU-T provide services allowing finding a standard via internet. C) How to obtain a standard? CENELEC and CEN standards are sold only by their respective members. This means that you can only buy the European standards at the national standard organisations. The prices of the standards are different according to the member from whom they are purchased, so it is worth comparing the prices especially that some national standardisation bodies offer the standards in the original working language i.e. English, German or French. ETSI standards on the other hand can be downloaded free of charge directly from the ETSI website after simple registration. International standard organisations sell their standards directly through their electronic portals. The standards of ISO or IEC can also be obtained through the websites the national organisations being members of ISO or of IEC. However, ISO web store is quite convenient one as it offers both ISO and IEC standards. ITU sells its standard through its own web store. Please remember that standards are protected by copyrights and it is forbidden to copy them for further distribution or commercial use. 22