CONFORMITY ASSESSMENT FOR DEVELOPING COUNTRIES

Transcription

1 Edition CONFORMITY ASSESSMENT FOR DEVELOPING COUNTRIES Guidelines CA Guide:2008(E)

2 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office 3, rue de Varembé CH-1211 Geneva 20 Switzerland Web: About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee, ). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by . Electropedia: The world's leading online dictionary of electronic and electrical terms containing more than terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: csc@iec.ch Tel.: Fax:

3 Edition CONFORMITY ASSESSMENT FOR DEVELOPING COUNTRIES Guidelines INTERNATIONAL ELECTROTECHNICAL COMMISSION Registered trademark of the International Electrotechnical Commission

4 2 CA Guide IEC:2008 CONTENTS INTRODUCTION...4 MESSAGE FROM THE CHAIRMAN OF THE IEC CONFORMITY ASSESSMENT BOARD (CAB) Conformity Assessment (CA) in general What is conformity assessment? The relationship between standards and CA The goals of CA General The One-One-One principle: one standard, one test accepted everywhere, one CA mark where relevant Safety Performance Interoperability The goals of 1st, 2nd and 3rd-party CA Mechanisms of CA General Activities Certification Assessment of CA bodies Peer assessment Accreditation Confidence and mutual recognition WTO Agreement on Technical Barriers to Trade (TBT) Use of standards and CA in government regulations Infrastructure and preconditions for CA The IEC s CA Systems IECEx, IECEE and IECQ Aspects common to all Systems Principles governing the IEC CA Systems Organization and functioning Specific benefits of IEC CA for developing countries IECEE IECEx IECQ What developing countries can do How developing countries can use IEC CA Systems Using IEC Conformity Assessment for regulations Using IEC Conformity Assessment for development...20 CONCLUSION...21

5 CA Guide IEC: Annex A List of ISO/IEC Guides and Standards from ISO/CASCO...22 Annex B Facilitated adoption of IEC International Standards under the Affiliate Country Programme...24 Annex C Conditions for bodies and organizations domiciled in non-iec Member countries to become members of an IEC CA System...26 Figure 1 Certification of a product according to the principle one standard, one test, one certification accepted everywhere...8 Figure 2 The IEC s organizational structure...14 Figure 3 IEC s conformity assessment structure...14

6 4 CA Guide IEC:2008 INTERNATIONAL ELECTROTECHNICAL COMMISSION Conformity Assessment for Developing Countries Guidelines INTRODUCTION The International Electrotechnical Commission (IEC) is the body responsible for the development of International Standards in the field of electrotechnology. It has the equivalent status in the standardization world to that of the International Organization for Standardization (ISO) and the International Telecommunication Union (ITU). International Standards produced by IEC, ISO and ITU serve as the basis for national standards and regulations in countries and regions worldwide. The IEC s International Standards cover products, processes and testing. While publishing International Standards, the IEC also operates three conformity assessment (CA) systems that offer a means of assessing conformity or certifying products, components or processes to the standards produced. The three IEC CA Systems cover the safety and performance of electrical equipment (IECEE), equipment and services for explosive atmospheres (IECEx), and the quality of electronic components (IECQ). The goal of the IEC in producing International Standards and operating the Conformity Assessment Systems is to offer a one-stop shop : a single source for one standard, one test and one certificate. The three Systems operate under the corporate umbrella of the IEC. NOTE 1 Information on the IEC s Conformity Assessment (CA) Systems, directed primarily at its Member Countries, is publicly available on the IEC website. The present document is intended to complete the available material with information likely to be directly usable by developing countries. NOTE 2 An extended discussion on conformity assessment, including the developing country perspective, may be found in the World Trade Organization s World Trade Report 2005 Exploring the links between trade, standards and the WTO.

7 CA Guide IEC: MESSAGE FROM THE CHAIRMAN OF THE IEC CONFORMITY ASSESSMENT BOARD (CAB) Participation in the IEC should result in creating confidence in international trade amongst the governments and consumers of developing countries. Governments and consumers should be confident that they can enjoy secure supplies and better choice of electrical and electronic products by using IEC Standards and established conformity assessment processes. What about the role of IEC Conformity Assessment? The IEC encourages developing countries to use the IEC Conformity Assessment Systems IECQ, IECEx and IECEE by developing a national procurement guideline, particularly for imports. How can IEC enhance the active participation of developing countries? First, the national standards and conformity assessment infrastructure needs strengthening, among other methods by collaboration with international capacity-building projects. Secondly, training is required on the use and benefit of IEC International Standards. Thirdly, countries need assistance so that conformity assessment can be brought in line with Article 5 of the WTO Agreement on Technical Barriers to Trade, Procedures for Assessment of Conformity by Central Government Bodies. Finally, the active participation of stakeholders is needed at the country level (essentially industry), where possible involving creation of a National Electrotechnical Committee. National stakeholders should be coordinated at sub-regional, regional and international levels to achieve a unique effect that is designed to serve the interests of developing countries in general. Countries that are members of regional bodies could work together and submit common comments on IEC projects or raise questions regarding the interpretation of existing IEC International Standards. They could collaborate under the guidance of other IEC National Committees which could agree to act on a tutorial or mentoring basis. The present guidelines, prepared jointly by the IEC Conformity Assessment Board (CAB) and the IEC Conformity Assessment Systems (IECQ, IECEE and IECEx), are intended to help developing countries implement a conformity assessment programme and meet a top priority for most of them: ensuring the safety of electrical articles sold to consumers.

8 6 CA Guide IEC:2008 Conformity Assessment for Developing Countries Guidelines 1 Conformity Assessment (CA) in general 1.1 What is conformity assessment? Conformity Assessment (CA) is any activity which results in determining whether a product or other object corresponds to the requirements contained in a specification. A specification, typically but not exclusively a standard, is a technical description of the characteristics which are required to be fulfilled by some object. These objects may be products (which in this context include services), processes, bodies, people or systems (management systems, for example). Officially, CA is the demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. Note that the phrase conformity assessment does not limit or classify the activity in any way a consumer who buys an appliance and at home checks that it conforms to a technical description may be said to be carrying out conformity assessment. In CA there are three types, differentiated by the body which carries out the assessment: 1st party, the seller (officially, person or organization that provides the object ), usually producing a supplier s declaration of conformity (see 1.3.6): a manufacturer does in-house testing. 2nd party, the buyer (officially, person or organization that has a user interest in the object ): the purchaser does his or her own testing. The example given above of a consumer checking an appliance at home is of this type. 3rd party, neither seller nor buyer (officially, person or body that is independent of the 1st and 2nd parties): an independent testing service does the testing. Some typical CA activities (several will be mentioned in this guide see 2.2 to 2.6) are: testing, inspection, sampling, audit, assessment of CA bodies, accreditation, certification, surveillance. 1.2 The relationship between standards and CA A good standard is written so as to allow conformity to its requirements to be assessed: it describes the function and behaviour of the product, rather than its design; it gives precise, measurable specifications; it mandates tests and test methods which are reliable and reproducible. Further, it should be equally usable for 1st, 2nd or 3rd-party CA. These characteristics ensure that the link from a standard or specification to CA activities will be successful and correspond to users expectations.

9 CA Guide IEC: In CA, as in other applications of standards and technical specifications, the highest level is represented by assessment to international standards, since these are the consensus result of the best technical and pragmatic efforts of the whole international community. Information that a product conforms to them is therefore of the highest value and shows that the requirements of the largest possible community of potential users are satisfied. However, conformity may be assessed to a national or regional standard, or in fact to any specification. This may be for local purposes, or because an international standard does not yet exist, or it may involve specifications of a different type from international standards. The IEC Conformity Assessment Systems are based on IEC International Standards but do allow for national differences where appropriate. 1.3 The goals of CA General The purpose of CA is to help users of products, processes, etc. obtain the expected benefits from those products, by showing that they behave as their specifications promise. To achieve this purpose, it is important that the results should be reliable and usable without difficulty, and that not too much extra cost is incurred. Consequently the different goals of CA may be summarized as follows The One-One-One principle: one standard, one test accepted everywhere, one CA mark where relevant The best result of the standards-ca system as a whole is achieved when there is a single international standard used by all, when a single test carried out anywhere in the world is sufficient and accepted everywhere else, and when a single mark is universally accepted as demonstrating that the product is conformant. At the same time it is recognized that a single mark is not currently relevant everywhere, since today some national legislations and many other market forces mandate a range of different marks (as those who have looked at the relevant panel of an electrical or electronic device will have noticed). Recognizing that for certification the one test accepted everywhere is ideally completed by one certification accepted everywhere, an alternative version of the same principle therefore reads, one standard, one test, one certification accepted everywhere. Independently of marks, the one standard, one test and one certificate already represent a major advance for users (see Figure 1), and the IEC contributes significantly to all of them. In publishing international standards it provides the one standard, and in operating three CA systems (see Clause 4) it achieves worldwide acceptance for the one test in the domains of those systems. These are major contributions to the facilitation of international trade, and to the reduction of costs for both manufacturing and CA.

10 8 CA Guide IEC:2008 Figure 1 Certification of a product according to the principle one standard, one test, one certification accepted everywhere Safety The most frequent requirement for CA comes from the desire to demonstrate that a product or process is safe and that in use it will not cause injury to humans or animals or any other harm. This is also the most frequent reason to prefer certification (3rd-party CA) to 1st-party CA, in order to obtain an unbiased assurance of safety. Governments need to protect the population and insurers want the assurance that equipment will not cause loss of life or damage Performance When the standard specifies requirements for performance, behaviour and other characteristics of the product or process (in a word, its fitness for purpose), CA becomes useful for the distributors, buyers and end-users who have an evident interest in getting what they expect. The performance of a product includes several aspects: its effectiveness (doing the job it was designed for); its quality; its efficiency; its economic use of materials and energy; and its effect upon the environment (pollution, noise). These contribute to value for money, provide public benefit, or both.

11 CA Guide IEC: Interoperability Where a specification provides the rules for how products may operate with each other communicate or fit together, for example CA can assure the future user that this will happen correctly. If a company s own products conform to an interoperability standard, it and its customers have an interest in knowing whether other products on the market have been shown to be interoperable The goals of 1st, 2nd and 3rd-party CA First-party CA, usually called a Supplier s Declaration of Conformity (SDoC), is the means whereby the manufacturer or supplier declares on his own responsibility that tests and other activities, which are needed to show that the product is conformant, have been carried out. Where no great danger exists, and in particular where commercial partners find it useful to note the supplier s undertaking that the standard has been followed, a supplier s declaration of conformity is sufficient and no independent checking is needed. Costs are thereby reduced. In this way, the principal goal served by first-party CA is information that a particular standard applies and a demonstration of commitment on the part of the manufacturer. Note that, in the general case, a manufacturer or distributor will not simply rely on product design or manufacturing methods to ensure that the product is conformant, but will also carry out typical CA activities, especially testing and inspection but also assessment of his own systems. Some national regulators will accept SDoCs for low risk products. A very large, important or demanding customer, typically a government, but in some past cases a major car manufacturer, may institute its own CA for products and services it acquires. This is 2nd-party CA, where for example a government s own test facilities and assessment procedures are applied to guarantee the quality of its suppliers goods. The purpose may be to obtain better assurance of conformity than if the suppliers carried out 1stparty CA given that they are often smaller and have fewer facilities while at the same time not incurring as much overhead as 3rd-party testing. The quality and expertise of government laboratories may also play a role. For special purposes or where mandated by law, 2nd-party CA may still happen, but today it is the least frequent type. 3rd-party CA, usually called certification, provides the highest level of confidence, while requiring more resources certification bodies are usually for-profit companies. Insofar as the one-one-one principle (see 1.3.2) is implemented, however, costs are limited to one test and one certificate, which for a global market is a tolerable overhead. The major goal of certification is independently-provided assurance of safety of products and processes, e.g. those involving dangerous substances or activities, or the quality of very complex production processes. Certification is applied where a major market makes it cost-effective or where it is mandated by legislation. These criteria are notably fulfilled in the case of the IEC CA Systems (see Clause 4), which are 3rd-party systems. 2 Mechanisms of CA 2.1 General How to carry out CA properly, professionally and effectively is itself the subject of international standards. ISO and IEC have a full set of international standards on conformity assessment, developed in ISO/CASCO, the ISO Committee on Conformity Assessment, with the full involvement of the IEC. These standards are often referred to as the CASCO Toolbox, and give much more information on many of the subjects covered in this guide 1. In particular ISO/IEC 17000, Conformity assessment Vocabulary and general principles, provides general information and definitions applicable to CA mechanisms. 1 More information may be obtained from A list of the ISO/IEC Guides and Standards concerned is given in Annex A and was available, at the time of publication of the present guide, on the following web page:

12 10 CA Guide IEC:2008 In this guide, as in ISO/IEC 17000, the term product includes services as well as physical objects such as parts or appliances. Thus CA activities such as testing and especially inspection may apply to services, and no further distinction is made here between product and service. However, there are some distinctions which are important, notably those concerning the possible objects of CA: product, process, system, person or body. Product CA typically involves examining physical characteristics and behaviour (using especially testing and inspection). By contrast, CA of a process or a management system while it also looks at behaviour of mechanisms or individuals mainly consists of examining the structure, rules and documentation prepared for the system s functioning. This type of examination is normally termed assessment. (Note that this term is of course also used much more generally, as in the phrase conformity assessment itself.) Processes which may form the object of CA include in particular manufacturing processes, and the most common form of system which is examined is the management system. The longest-standing example of this is quality management assessed against the ISO 9000 series of standards, with environmental management (against the ISO series) and more specialized, sectorspecific management systems having been added more recently. A person, at least in her or his professional role, may also form the object of CA, which consists in evaluating the training, skill and performance of the person against the criteria specified in a standard. Finally, when one talks of a body (organization) forming the object of CA, by convention one is referring only to a CA organization itself, typically a certification body or test laboratory. This is because for other types of organization CA is normally limited to their management systems, since that is what the market needs. 2.2 Activities A CA process consists of a number of activities, most of them briefly described in this and the following subclauses. They are carried out in a certain order dictated by the requirements of the object, the situation (desired results) and the standard being applied. In the example of a physical product the most frequent in relation to IEC Standards the first activity is sampling, the selection and obtaining of examples of the product to test. The testing then follows, often with the use of test equipment and measuring devices but also by examination (of a material type, for example). The results are evaluated to determine if the standard has been followed, and a decision is taken either a negative decision, or a positive decision to issue the SDoC (1st party) or certificate (3rd party). 2.3 Certification Certification of a product follows the general sequence outlined in 2.2. Its specificity is threefold: it is a 3rd-party method, i.e. the certificate is issued by an independent certification body (CB); by issuing the certificate, the CB assumes a certain amount of responsibility for the testing and evaluation, beyond that of the manufacturer or retailer; and some countries regulations mandate certification in order for certain products to be allowed onto the market. A certification programme may be more or less elaborate and contain various elements, depending on the product, the context and the requirements. ISO/IEC Guide 67, Fundamentals of product certification, contains examples, called Systems 1 to 6, of possible schemes containing the various elements. The two most useful to review briefly here are System 1b, consisting of sampling, testing, evaluation and certification, and System 5, which adds to this the ongoing surveillance of either the manufacturing or the delivered products, or both. A System 1b scheme will therefore give an assurance of the conformity of the product when the samples were tested and evaluated, but no further assurance about the continuing conformity of future products. (Of course the certification may be renewed or repeated, in which case assurance of conformity is again obtained.) A System 5 scheme, often called full

13 CA Guide IEC: certification, additionally examines the manufacturer s quality management system or manufacturing process, and also tests further samples obtained during ongoing surveillance. It can therefore attest to the ongoing conformity of the products produced by that manufacturer. 2.4 Assessment of CA bodies The results of test laboratories (including those operated by manufacturers), certification bodies and inspection bodies which carry out CA, would not be useful or accepted if these bodies were not doing their jobs properly. The same would apply if they were, for example, under strong pressure from their shareholders to bias their results in favour or against certain manufacturers. It is therefore essential that they should be assessed as to their competence and independence, and, where relevant, the level of technology or reliability of their test equipment or the training provided to their staff. Many of the standards in the CASCO Toolbox (see 2.1) specify how the assessments should be done and what criteria should be applied. The following subclauses describe the two major methods used to organize the necessary assessments, peer assessment and accreditation. 2.5 Peer assessment Peer assessment organizes the assessing of the competence of CA bodies by using experts drawn from other CA bodies of the same type peers. So, for example, the team examining the competence and independence of a testing laboratory, for a certain range of products and applying a particular series of standards, will be drawn from other laboratories capable of carrying out similar tests. Typically members of the small assessment team will be from a range of different laboratories, and even from a number of countries if the system in which the laboratory takes part is an international one. A similar process is used for certification bodies. Although the team members will be employees of organizations which may be in competition with the one being assessed, the mutual nature of the system will encourage them to be thorough and honest in their assessment. This is because their own organization will later be subjected to a similar assessment involving its competitors. An additional advantage is that the team members are likely to be experienced experts in precisely those issues which they must examine for the assessment, since their day-to-day work involves the same factors. The IEC s CA Systems use the peer assessment method. 2.6 Accreditation Accreditation is a function carried out by special organizations, called accreditors, which have received the authority usually from government to assess CA bodies. They train and employ experts who examine the independence, competence, skill, etc. of the CA body being assessed, and if the evaluation is positive the CA body may claim to be an accredited body. This will then serve as the basis for the mutual recognition (see 2.7) of each other s CA results, and also for the acceptance by the market of these CA results as being of high quality. Accreditors themselves use the peer assessment method (see 2.5) to establish confidence in each other, as a basis for their mutual recognition arrangements. 2.7 Confidence and mutual recognition The one-one-one principle (see 1.3.2) can only be realized if CA bodies recognize and accept each other s results, otherwise a certification body would for example insist on repeating the laboratory tests that had already been carried out once. However, in order to accept the results of a distant laboratory with which it has no direct relationship as a basis for a certificate for which it must assume responsibility, the certification body (CB) must have a high level of confidence in the accuracy and impartiality of the laboratory s work. Thus mutual confidence is an essential part of cost-effective and efficient CA; it may even be said to be the most important single element.

14 12 CA Guide IEC:2008 The practical arrangements for mutual recognition need careful planning if they are not to involve enormous overheads. For example, if a CB needed a separate agreement with every laboratory in the world in order to implement the one test principle, it would need hundreds of agreements, each of them requiring negotiation and maintenance. A part of the negotiation would be how each laboratory was to be assessed, which itself would need organizing. If this scenario was repeated for each CB, the practical impossibility of this approach for any but the simplest and smallest domain becomes apparent. The solution is for all the relevant CBs and laboratories to get together and sign a single agreement describing how assessments take place and what the conditions for recognizing test results are. Then not only will the multiple agreements be replaced by one, but no CB needs to organize its own assessments since the agreement will already have covered them. Such an agreement is called a mutual recognition arrangement. (The expression mutual recognition agreement is conventionally reserved for similar agreements among governments rather than CA bodies.) The three IEC CA Systems IECEE, IECEx and IECQ are mutual recognition arrangements. Accreditors also have mutual recognition arrangements; the international associations IAF and ILAC were established for this purpose. 2.8 WTO Agreement on Technical Barriers to Trade (TBT) Both the IEC and the World Trade Organization (WTO) aim to encourage international trade, so it should come as no surprise that a relationship between the two exists. IEC, ITU and ISO are recognized and promoted by the WTO as international standardization bodies, since the application of a single international standard everywhere is more conducive to free trade than if each country applied different technical standards to the products sold there. In particular, the large majority of WTO member states have signed the WTO Agreement on Technical Barriers to Trade, which spells out both commitments and best practice for states in the application of standards and CA. Its elements include the one-one-one principle (see 1.3.2), transparency, conflict resolution and equal opportunities for all states and all trading entities (manufacturers, etc.) a world-wide level playing-field. 2.9 Use of standards and CA in government regulations Governments have an interest in protecting their populations from danger, and this may include danger from household goods and many other sources for which safety standards exist. Consequently, there is a link between standards (especially according to the WTO TBT Agreement international standards), assessing the conformity of products or public facilities to those standards, and national legislation or regulations. In some countries such links exist, while in others there is no link or it is indirect. That is because international standards and the related activity of most CA bodies are both voluntary, whereas government regulations are mandatory. Regulations form no part of the role of the IEC or its CA Systems; the IEC s role is simply to produce the best possible international standards and offer the best possible certification to them. It is then the role of the national regulator to choose whether or not to make use of the international standards or the established conformity assessment systems as the basis for permitting the sale of products within the country 2. For developing countries, the situation is formally identical, but in practice it may be rather different. Where currently little or no practice of regulation exists, or is based on less solid grounds than international standards and CA, the regulator often has no other cost-effective choice than to build upon these. There may also be other reasons or commitments to establish a closer link between regulation and CA involving international standards, such as the following situations: 2 However, it should be noted that the regulator is strongly recommended to do so by the WTO TBT Agreement. It is also worth remarking that the greatest added value from CA is realized when the CA results (test reports, certificates) from a distant country are recognized by the regulator as permitting direct entry to the national market, rather than demanding that a national certificate or mark be issued first. Even if this takes place on the basis of the existing results, more time and money are needed. In fact, in more and more cases the IEC CA Systems certificates are recognized by regulators as allowing direct entry into the national market.

15 CA Guide IEC: participation in the IEC Affiliate Country Programme (see Annex B); participation in an IEC CA System as a non-member-country of the IEC (see Annex C); or benefiting from development programmes (e.g. those of the UN Industrial Development Organization, UNIDO, or the UN Development Programme, UNDP) which may require such a link. 3 Infrastructure and preconditions for CA The technical and regulatory infrastructure of a country must present certain characteristics before one may expect to derive maximum benefit from international standards and CA: established metrology infrastructure, both in legal metrology and facilities for traceable calibration of laboratory equipment; competent product test laboratories, whether government or private, with up-to-date equipment; trained personnel, both for laboratories and for government agencies (e.g. regulators); a stable, well-publicized regulatory regime, clearly organized at national level and determining the roles of government agencies and certification bodies. Assistance with these may be obtained by collaboration with international capacity-building projects such as those run by development programmes, both from UN agencies such as UNIDO and UNDP and by various developed countries. 4 The IEC s CA Systems IECEx, IECEE and IECQ 4.1 Aspects common to all Systems Principles governing the IEC CA Systems Three major principles govern the IEC CA Systems: openness, democracy (including transparency), and obligatory mutual recognition. Openness is twofold. On the one hand, anyone in the world may freely use the CA services offered and CA results produced by the Systems. It is not necessary to be a member or even to be situated in an IEC-member country; any manufacturer may request a certificate for his products and anyone may access and derive benefit from the Systems certificates, available publicly on the Internet, to determine whether particular products have been certified. On the other hand, any organization which undertakes to follow the rules may join the Systems. The members are organizations, at most one per country, which on being admitted to a System become responsible for their country s testing and certification activities within the System. An organization (usually a representative national committee) may become a member if it fulfils the criteria laid down in the rules, even if it is situated in a country outside the IEC membership (see Annex C). Any certification body or testing laboratory may be proposed by a member body to participate in a System, provided that it conforms to the criteria laid down in the rules. Democracy involves governance and transparency. All significant decisions in the Systems are taken by the full membership, and these decisions as well as all rules and information relevant to the activity of the Systems are published and freely available to all in the System. Obligatory mutual recognition is the base upon which the Systems major added value rests. It implies that no repeat tests are necessary and enables faster and more economic entry into distant markets for manufacturers. It also provides a global assurance that, no matter where a test was carried out or a certificate was issued, it has the same value.

16 14 CA Guide IEC: Organization and functioning CA in the IEC is supervised by the Conformity Assessment Board (CAB), one of three management-level committees reporting to the Council Board which functions as the IEC s board of directors (see Figure 2). The Standardization Management Board (SMB) is responsible for International Standards work while the Market Strategy Board (MSB) is still in the process of being fully established. Figure 2 The IEC s organizational structure The CAB s two major responsibilities are the IEC s CA policy and strategies on the one hand, and supervision of the three Systems on the other (see Figure 3). Figure 3 IEC s conformity assessment structure

17 CA Guide IEC: The Systems themselves do no testing or certification; as explained in 2.7, they are mutual recognition arrangements involving certification bodies (CBs) and testing laboratories (TLs). Their members (see 4.1.1) form the Management Committee, which is the governing body of each System. The members endorse applications from CBs or TLs in their country which wish to take part in the System, and these in turn are accepted by the System on the basis of the rules, including being subject to peer assessment (see 2.5). Each System is governed by a set of rules published as the Basic Rules (identified as publications IECEx 01, IECQ 01 and IECEE 01) and further Rules of Procedure (published as IECEx 02, etc.). The services the Systems provide (certification, etc.), the standards to which conformity is assessed and the industrial sectors in which they are active are a function of market demand. The IEC s strategy is to respond to clear needs from the market. There are no ready-made recipes, neither in standards nor in CA, which would allow us to prioritize or define in advance the work which it would be useful to do only the market can do that. Consequently, the services offered change and develop over time. Currently all three Systems are in a phase of expansion: the use of most existing services is growing, and gradually new services are being identified and introduced Specific benefits of IEC CA for developing countries For a country with little or recently developed manufacturing industry, two major development thrusts can benefit from use of IEC conformity assessment: infrastructure development (see also Clause 3), and quality and safety of imported equipment. Some potential actions will encourage infrastructure development, either directly or indirectly: build or subsidize relevant laboratories or other installations, alone or in cooperation with international funding bodies or donor countries, adopt IEC International Standards as national standards, require electrical and electronic products to conform to international standards, adapt public procurement rules and official incentives in the same direction, and possibly enact government regulations requiring products made, imported and sold to be certified. Besides the direct effects, these steps will give national industry and importers the requisite signal to put in place a modern manufacturing infrastructure. The encouragement or requirement for conformity may be 1st party Supplier s Declaration of Conformity (SDoC) or it may rely on the IEC s 3rd-party Systems. In both cases, CA sets the goal for industry to develop its manufacturing facilities so as to be able to produce equipment conforming to IEC International Standards. To guarantee that only safe and high-quality equipment and services are sold to consumers and industry, governments have an interest in requiring imported goods to conform to identified standards. Once IEC International Standards have been adopted nationally, regulations may be issued to require importers and distributors to show that the products concerned have been assessed as conforming to IEC International Standards. This establishes confidence that they are safe, and also goes a long way to ensuring their quality and fitness for purpose the market of course also contributes to determining this. Since the IEC CA Systems are international and one test or certificate is normally recognized everywhere without re-testing, the certification for imports may come from any of the IEC CA System s members or registered certification bodies. Moreover, the importing country does not need to be a member of the Systems, nor to have its own laboratories available. It is sufficient to require the existence of a test certificate. Since the certificates may be publicly consulted on the web, this presents no difficulty.

18 16 CA Guide IEC:2008 The country s government, importers and consumers consequently benefit from: the widest range of acceptable products, guaranteed neutrality no supplier countries favoured, assurance that the certificate issuer has adequate and enduring technical competence (6.1.1 of the WTO TBT Agreement), confidence that there will be no dumping of poor-quality goods and services, confidence that there will be no hiding behind false origins goods built in one place but trans-shipped through another. 4.2 IECEE IECEE is the worldwide system of conformity assessment schemes for electrotechnical equipment and components. It consists of two schemes (or programmes), the IECEE CB Scheme and the IECEE CB Full Certification Scheme (FCS). The former is a system 1b scheme (see 2.3), also often referred to as a product test certificate scheme, and the latter is its extension to a full system 5 scheme. In both schemes, the rules require all members to publish any national differences, special conditions or regulatory requirements in their country with respect to all the standards used for certification. This is a large task, but essential in order to enable all members to issue certificates which will be useful and recognized everywhere. The CB Scheme covers a wide range of products and services, for safety, performance and electromagnetic compatibility: Information technology (IT) and office equipment Electronics, entertainment Electrical equipment for medical use Installation accessories and connection devices Safety transformers and similar equipment Lighting Switches and automatic controls for electrical household appliances Portable tools Electrical equipment for railway rolling stock Photovoltaics Household and similar equipment Measurement, control and laboratory equipment Low voltage, high power switching equipment Installation protective equipment Capacitors as components Batteries Cables and cords Electric toys.

19 CA Guide IEC: The current figures describing the System give a picture of its extent: 52 participating countries 65 national certification bodies 255 testing laboratories and 19 satellite laboratories manufacturers laboratories certificates issued in ver current certificates More than manufacturers currently using the CB Scheme. IECEE on-line certificates permit immediate verification and are available anywhere there is access to the Internet: IECEx IECEx is the worldwide system for certification to standards relating to equipment for use in explosive atmospheres ( Ex equipment ). It consists of three programmes: the Equipment Scheme (a full system 5 scheme see 2.3), the Services Scheme (Ex-equipment-related services such as repair and overhaul), and the Mark Licensing Scheme, which allows the IECEx Mark to be affixed to certified equipment. Ex equipment can be almost any electrical device, but because of its use in this dangerous environment, the safety (and performance) standards which apply are more stringent. Ex equipment is frequently found in locations such as the following: Automotive refuelling stations or petrol stations Oil refineries, rigs and processing plants Chemical processing plants

20 18 CA Guide IEC:2008 Printing industries, paper and textiles Hospital operating theatres Aircraft refuelling installations and hangars Surface coating industries Off-shore oil platforms Underground coal mines Sewage treatment plants Gas pipelines and distribution centres Grain handling and storage installations Woodworking areas Sugar refineries Metal surface grinding, especially aluminium dusts and particles. IECEx on-line certificates act as a buyer s guide of Ex products and can be viewed and downloaded anywhere there is access to the Internet: IECQ IECQ is the worldwide quality assessment system for electronic components. It consists of three schemes: electronic component certification; Hazardous Substance Process Management (HSPM) programme, including lead-free; and avionics Electronic Component Management Programme (ECMP). The first programme contains elements of both product testing as well as process and system certification. The last two programmes take an exclusively process management approach in two very complex areas where a product test approach cannot be used. The HSPM Programme exists to certify that a manufacturer has systems providing confidence that allowed levels of hazardous substances will not be exceeded in its products. The ECMP certifies that a supplier to an aircraft manufacturer has systems which will allow it to continue to supply spare parts for aeroplanes, whose lifetimes may be much longer than electronic part life cycles.

21 CA Guide IEC: Electronic components represent a wide range of products: Active components, including integrated circuits Electromagnetic components Hybrid integrated circuits Electro-optic components Electromechanical components Passive components Printed boards Wires and cables. IECQ on-line certificates permit immediate verification and are available anywhere there is access to the Internet: 5 What developing countries can do 5.1 How developing countries can use IEC CA Systems Ensure that the minimum national infrastructure required to make use of international standards and CA is in place: Basic regulatory regime identifying which standards are acceptable and what form of proof of conformity is required. This will require risk assessment: safety of electrical products: medium to high risk, safety of products/services for explosive atmospheres (covered by IECEx): highest risk. Technical infrastructure (standards, certification and metrology). The active participation of stakeholders is needed at the country level essentially industry. Ensure any national or regional regulations recognize the relevant IEC CA System certificate or approval. Ensure that purchasing and tender documents call for IEC CA System Certificates or approval in order to prove compliance with IEC International Standards. Keep up-to-date with latest IEC CA System developments and service offerings. Attend or arrange regional or local IEC CA meetings, courses or conferences. Contact the relevant IEC CA System Secretariat for assistance. 5.2 Using IEC Conformity Assessment for regulations Priorities: determine which sectors and product families are a priority for conformity to standards. Adoption: obtain and adopt the IEC International Standards for those sectors. (Annex B gives information for countries which participate in the IEC Affiliate Country Programme.) Train relevant administrators, industry leaders, policy stakeholders in the policy and technical considerations and the contents of the standards. Decide policy: determine which standards are to be the subject of compulsory conformity (legislation, regulations), and which will be the subject of less constraining policy initiatives. Issue regulations: consult upon, write, discuss, refine the regulations. Implement and enforce: publicize the regulations and arrange that information and training should be available. Put in place the mechanisms for checking conformity and implement penalties for non-compliance.

22 20 CA Guide IEC: Using IEC Conformity Assessment for development Priorities: determine which sectors and product families are a priority for development. Adoption: obtain and adopt the IEC International Standards for those sectors. (Annex B gives information for countries which are members of the IEC Affiliate Country Programme.) Train relevant administrators, industry leaders, policy stakeholders in the policy and technical considerations and the contents of the standards. Build a community: publicize the potential for voluntary testing and certification, as well as other voluntary uses of standards, to industry and other stakeholders. Decide goals and plans: determine the potential (financial, technical) and the benefits (return-on-investment) of active participation in IEC CA Systems. Implement: if the return-on-investment is positive, establish test laboratories, certification bodies; become member of relevant IEC CA System(s).

23 CA Guide IEC: CONCLUSION Through the use of the IEC CA Systems, developing countries can reduce manufacturing costs by eliminating the cost of multiple testing and certification. With today s technology, IEC conformity assessment programmes enable them to access new products and new markets faster. Another advantage is broader access to the latest technology and innovative products. To benefit from the Systems, an importing country does not need to become a member, but has the choice of simply making obligatory the existence of a test certificate for any product (test certificates are available on-line on the Systems web sites). The test certificate may be checked, for example, by the government agency which grants import licences. It should also be noted, however, that membership in the IEC CA Systems provides significant additional benefits to developing countries. For any additional information on how to use and benefit from each System, countries are invited to contact the IEC CA Systems Officers: IECEE IECEx IECQ Pierre de Ruvo Chris Agius Chris Agius pro@iec.ch chris.agius@iecex.com chris.agius@iecq.org

24 22 CA Guide IEC:2008 Annex A List of ISO/IEC Guides and Standards from ISO/CASCO LIST OF CASCO GUIDES AND STANDARDS BY FIELD OF APPLICATION Vocabulary, principles and common elements of conformity assessment ISO/IEC 17000: 2004 ISO PAS 17001: 2005 Conformity assessment - Vocabulary and general principles Conformity assessment - Impartiality - Principles and requirements ISO PAS 17002: 2004 Conformity assessment - Confidentiality - Principles and requirements Product certification Code of good practice for conformity assessment Mutual Recognition Arrangements (MRAs) ISO PAS 17003: 2004 ISO PAS 17004: 2005 ISO PAS 17005: 2008 ISO/IEC Guide 23: 1982 Reconfirmed in 2003 ISO/IEC Guide 28: 2004 ISO/IEC Guide 53: 2005 ISO/IEC Guide 65: 1996 ISO/IEC Guide 67: 2004 ISO/IEC Guide 60: 2004 ISO/IEC Guide 68: 2002 Conformity assessment - Complaints and appeals - Principles and requirements Conformity assessment - Disclosure of information - Principles and requirements Conformity assessment - Use of management systems - Principles and requirements Methods of indicating conformity with standards for third-party certification systems Conformity assessment - Guidance on a thirdparty certification system for products Conformity assessment - Guidance on the use of an organization's quality management system in product certification General requirements for bodies operating product certification systems Conformity assessment - Fundamentals of product certification Conformity assessment - Code of good practice Arrangements for the recognition and acceptance of conformity assessment results Accreditation ISO/IEC 17011: 2004 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies Inspection ISO/IEC 17020: 1998 Reconfirmed in 2002 General criteria for the operation of various types of bodies performing inspection System certification ISO/IEC 17021:2006 Conformity assessment - General requirements for bodies providing audit and certification of management systems