GSP_ Boas práticas em normalização.pdf

practices ISO PUBLICATION ON Good Standardization Practices Contents Preface......................................................................................................................................................................................................... 3 Acknowledgments........................................................................................................................................................................ 6 Disclaimer................................................................................................................................................................................................ 7 Acronyms and abbreviations.......................................................................................................................................... 8 1. Introduction........................................................................................................................................................................... 11 1.1 General........................................................................................................................................................................................... 12 1.2 Terminology.............................................................................................................................................................................. 12 2. Standardization fundamentals..................................................................................................................... 17 2.1 The history of standardization.............................................................................................................................. 18 2.2 Benefits of standardization...................................................................................................................................... 21 2.3 Definition of a standard................................................................................................................................................ 24 2.4 Diversity of standards.................................................................................................................................................... 24 2.5 Users of standards............................................................................................................................................................. 32 2.6 Quantifying socio-economic benefits of standardization...................................................... 34 3. The WTO and standardization........................................................................................................................ 39 3.1 World Trade Organization (WTO)....................................................................................................................... 40 3.2 WTO TBT Agreement principles........................................................................................................................... 43 3.3 Standards and Technical Regulations.......................................................................................................... 44 3.4 Technical regulations and SPS measures................................................................................................. 49 3.5 Annex 3 of the WTO TBT Agreement............................................................................................................... 56 ISO publication on Good Standardization P ractices – 1 4. Principles for the development of standards............................................................................. 63 4.1 The Six Principles of Standardization........................................................................................................... 64 4.2 ISO’s strengths in meeting the standardization principles................................................... 65 4.3 Principle #1 : Transparency....................................................................................................................................... 67 4.4 Principle #2 : Openness................................................................................................................................................ 70 4.5 Principle #3 : Impartiality and consensus................................................................................................. 72 4.6 Principle #4 : Effectiveness and relevance.............................................................................................. 76 4.7 Principle #5 : Coherence.............................................................................................................................................. 79 4.8 Principle #6 : Development dimension........................................................................................................ 81 4.9 Principle #7 : Stakeholder engagement...................................................................................................... 84 4.10 Principle #8 : Due process......................................................................................................................................... 86 4.11 Principle #9 : National adoption......................................................................................................................... 87 4.12 Gender equality..................................................................................................................................................................... 88 5. National standards body value chain................................................................................................... 89 5.1 The Quality Infrastructure (QI).............................................................................................................................. 90 5.2 NSB value chain.................................................................................................................................................................... 94 5.3 Diagnostic tool....................................................................................................................................................................... 96 6. NSB value chain : support activities....................................................................................................... 97 6.1 Administration and financial infrastructure........................................................................................... 98 6.2 Human resource management............................................................................................................................. 107 6.3 Product and technology development........................................................................................................ 109 6.4 TCs....................................................................................................................................................................................................... 112 7. NSB value chain : core activities................................................................................................................. 123 7.1 Planning......................................................................................................................................................................................... 124 7.2 Development............................................................................................................................................................................ 127 7.3 Publication................................................................................................................................................................................. 151 7.4 Dissemination......................................................................................................................................................................... 156 7.5 Customer services.............................................................................................................................................................. 163 Conclusion............................................................................................................................................................................................... 165 Standards referenced............................................................................................................................................................... 167 Annex A : Using the diagnostic tool....................................................................................................................... 169 2 – ISO publication on Good Standardization Practices Preface Good standardization practice (GSP) is, by definition, the best way of developing and publishing standards. Therefore, the objective of this publication is to provide guidance to a national standards body (NSB), primarily in a developing country, to operate in an effective and efficient manner the essential core-activities needed to develop and publish standards. Standardization is one of the main elements of the national quality-infrastructure in a country, the others being metrology, accreditation, conformity-assessment services and market surveillance. Standardization occupies a special place as the other organizations involved in the national quality infrastructure, base much of their work on the standards published by the NSB. Furthermore, in a modern society, standards contribute to sustainable development and in particular to trade, health and safety, and environmental protection. This publication describes the key elements of standardization, in the following logical sequence: ▸▸ the fundamentals of standardization; ▸▸ standardization in the light of the World Trade Organization Agreement on Technical Barriers to Trade (WTO TBT); ▸▸ internationally-agreed principles for the development of standards; and ▸▸ the value chain for the development of standards by an NSB. ISO publication on Good Standardization P ractices – 3 Ever since Michael E. Porter 1) defined the concept of a “value chain” in 1998, this concept has been widely used by organizations to identify all the elements of their operations and the linkages between them. The aim is to optimise these activities to make the process much more effective and efficient. Applying the value chain to an NSB identifies its “core activities”, i.e. the operations the NSB has to perform to develop and publish standards based on the needs of the country, and the “support activities” which describe the infrastructure and resources that must be available in an NSB to enable it to operate the essential core-activities effectively and efficiently. A major part of this publication identifies these elements of the value chain of an NSB, which can then be optimised by applying GSP. The “core activities” contain elements such as: (i) planning; (ii) development; (iii) publication; (iv) dissemination; and (v) customer services, as relating to national standards. The “support activities” deal with elements such as: (vi) administration and financial infrastructure; (vii) human resource management; (viii) product and technology development, and (ix) Technical Committees. This document describes all of these in great detail, allowing any NSB to evaluate its governance, infrastructure and processes in the light of established GSP. These value-chain elements also form the basis of a diagnostic tool, which. will allow an NSB to determine rapidly whether its value-chain elements are in place and whether they are effective. This publication complements the WTO Agreement on Technical Barriers to Trade and the ISO/IEC Guide 59:2019, ISO and IEC recommended practices for standardi- zation by national bodies, by providing guidance on how to comply with their necessary requirements. In this respect, ISO has taken the lead in capturing the collective good standardization practices of NSBs around the world, and making them available in a single publication for use for a wider audience, including not only NSBs in developing countries but all ISO members. 1) Porter, M.E. (1985). Competitive Advantage: Creating and Sustaining Superior Performance. The value chain is defined as all the activities that a company or organization needs to perform in order create a product or service. 4 – ISO publication on Good Standardization Practices This publication on GSP is a companion to previous publications ISO has made available, such as: ▸▸ Fast forward: National standards bodies in developing countries; ▸▸ Financing NSBs: Financial sustainability for national standards bodies; and ▸▸ Building trust: The conformity assessment toolbox (published in cooperation with UNIDO). Based on these publications ISO is providing support to build capacity amongst its members, with respect to GSP as part of ISO’s Action Plan for Developing Countries. ISO trusts that this publication will become a valuable addition to this knowledge base, for the benefit of the whole standardization environment. This publication on GSP is a “living” document and will periodically be updated. Sergio Mujica ISO Secretary-General ISO publication on Good Standardization P ractices – 5 Acknowledgments The content of this publication was developed by Martin Kellermann, an interna- tional expert on standardization and quality infrastructure. The ISO Central Secretariat oversaw and coordinated the work on this publication, notably Nesreen Al-Khammash with an input and support from Erich Kieck at the capacity building unit. The publication has greatly benefited from the substantive inputs and comments from the following: 1. Karl Grün, Director standards development, Austrian Stand- ards International. 2. Ernst-Peter Ziethen, International expert on standardization. 3. Belinda Cleeland, Head of research and innovation, ISO/CS. 4. The Chair of the ISO Committee on Developing Country Matters (DEVCO), Léna Dargham, and in particular the members of the DEVCO Chair’s Advisory Group (CAG) : ▸▸ Tatjana Bojanic, Serbia. ▸▸ Camilla Åberg, Sweden. ▸▸ Nadita Ramachala, Trinidad and Tobago. ▸▸ César Díaz Guevara, Ecuador. 5. The international engagement team from Standards Australia. The work was funded by the contribution from the Swedish International Devel- opment Cooperation Agency (Sida) within the framework of the ISO Action Plan for Developing Countries 2016-2020 and we wish to greatly acknowledge the con- tinuous and generous support of Sida to ISO’s activities in developing countries. Finally, we would like to thank Rick Gould and the Marketing and Communication team at the ISO/CS who provided significant support to the editing and finalization of this publication. 6 – ISO publication on Good Standardization Practices Disclaimer The publication does not imply the expression of any opinion whatsoever on the part of the ISO concerning the legal status of any country, territory, city or area or its authorities, or concerning the delimitation of its frontiers or boundaries. This document has been developed by the author mentioned above, with editing and publishing by ISO. Discussions and recommendations do not necessarily reflect the views of ISO and are not endorsed by ISO. While every effort has been made to verify the information contained in this document, ISO cannot accept any responsibility for any errors that it may contain. This document is strictly an information document and in no way represents the consensus views contained in ISO standards and other ISO deliverables. ISO publication on Good Standardization P ractices – 7 Acronyms and abbreviations ARSO African Organization for Standardization BIPM International Bureau of Weights and Measures CAC Codex Alimentarius Commission CASCO ISO Committee on Conformity Assessment CD committee draft CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization COPANT The Pan American Standards Commission CROSQ Caribbean Community Regional Organisation for Standards and Quality CMC calibration and measurement capability DCMAS Developing Country Network on Metrology, Accreditation and Standards DEVCO ISO Committee for Developing Countries DIS draft International Standard ETSI European Telecommunication Standardization Institute FDIS final draft International Standard GAP good agricultural practice GATT General Agreement on Tariffs and Trade GSP good standardization practice IAF International Accreditation Forum IEC International Electrotechnical Commission ILAC International Laboratory Accreditation Cooperation IPPC International Plant Protection Convention ISO International Organization for Standardization ISO/PAS ISO publicly available specification ISO/TR ISO technical report ISO/TS ISO technical specification ITU International Telecommunication Union KCDB key comparison database 8 – ISO publication on Good Standardization Practices KPI key performance indicator NAB national accreditation body NGO non-governmental organization NMI National Metrology Institute NSB national standards body NSS national standardization strategy NTB non-tariff barrier NWIP new work-item proposal OECD Organization for Economic Cooperation and Development OIE International Office of Epizootics OIML International Organization of Legal Metrology PEG process-evaluation group POCOSA ISO Policies and Procedures for Copyright, Copyright Exploitation Rights and Sales of ISO Publications QI quality infrastructure RIA regulatory impact assessment RSB regional standards body SWP standards work programme SC subcommittee SPS Sanitary and Phytosanitary Measures STC specific trade concerns TBT Technical Barriers to Trade TC technical committee TMB technical management board USD United States Dollar UNIDO United National Industrial Development Organization WG working group WTO World Trade Organization ISO publication on Good Standardization P ractices – 9 1. Introduction ISO publication on Good Standardization P ractices – 11 1.1 General Good operating practice is a strategic management term. More specific uses of the term include good agricultural practices, good manufacturing practice, good laboratory practice, good clinical practice and now also good stand- ardization practice (GSP). Generally speaking, a good operating practice is a method or technique that has been generally accepted as superior to any alternatives because it produces results that are superior to those achieved by other means, or because it has become a standard way of doing things due to the good results. Driven by the growth of international trade and technological cooperation, standards bodies have developed procedures and modes of cooperation which are commonly considered to constitute good practices for standards development at all levels. Some of these have been codified in international agreements such as the WTO TBT Agreement, in procedures such as the ISO/IEC Directives, others in international guides such as ISO/IEC Guide 59, and many are found in the intrinsic knowledge base of standards bodies all over the world – all of which are collectively known as good standardization-practice (GSP). This publication is a monograph on the history and the driving forces for stand- ardization, the international context for standards development, the principles of standards development and the elements of the value chain of standards devel- opment, that are effective and efficient in fulfilling the GSP concepts. It may be utilized by any standards body to evaluate its standards development, publication and information systems in order to ascertain the level of its compliance with GSP. This knowledge should help the standards body to optimise its processes within the realities of its environment. 1.2 Terminology It is important to use concepts and definitions consistently, because some terms mean different things to different practitioners. In general, this document uses 12 – ISO publication on Good Standardization Practices the terms and definitions contained within the following two, international documents : ▸▸ ISO/IEC Guide 2:2004 – Standardization and related activities – General vocabulary, and ▸▸ ISO/IEC 17000 2) – Conformity assessment – Vocabulary and general principles. The definitions of concepts as provided for in the WTO TBT Agreement are also important, and where they differ from those in international documents, this difference is highlighted. Some of the more important terms and definitions are included below. Standardization is the activity of establishing, with regard to actual or potential problems, provisions for common and repeated use, aimed at the achievement of the optimum degree of order in a given context. NOTE 1 : In particular, the activity consists of the processes of formulating, issuing and implementing standards. NOTE 2 : Important benefits of standardization are improvement of the suitability of products, processes and services for their intended purposes, prevention of barriers to trade and facilitation of technological cooperation (ISO/IEC Guide 2). A Standard is a document, established by consensus and approved by a recog- nized body, that provides for common and repeated use, rules, guidelines or char- acteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. NOTE : Standards should be based on the consolidated results of science, technol- ogy and experience, and aimed at the promotion of optimum community benefits. (ISO/IEC Guide 2). A Product is the output of an organization, and can be produced without any transaction taking place between the organization and the customer. NOTE 1 : Production of a product is achieved without any transaction necessarily taking place between provider and customer but can often involve this service element upon its delivery to the customer. 2) Under revision. Stage at the time of publication : ISO/DIS 17000:2019. ISO publication on Good Standardization P ractices – 13 NOTE 2 : The dominant element of a product is that it is generally tangible. NOTE 3 : Hardware is tangible, and its amount is a quantifiable characteristic (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are termed “ goods ”. Software consists of information regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical copyright, and a driving licence) (ISO 9000:2015). An additional concept in this document, and not contained in any of the above international documents is the following description for quality infrastructure, as agreed by the International Network of Quality Infrastructure 3) : ▸▸ The system comprising the organizations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to sup- port and enhance the quality, safety and environmental soundness of goods, services and processes. The quality infrastructure is required for the effective operation of domestic mar- kets, and its international recognition is important for enabling access to overseas markets. It is a critical element in promoting and sustaining economic devel- opment, as well as environmental and social wellbeing. It relies on : metrology, standardization, accreditation, conformity assessment and market surveillance. Other terminology that is used consistently is illustrated below. Interested party is any person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity. Therefore, in the context of standards, an interested party is any person or organization having an interest in the drawing up or use of a standardization document. Stakeholder is any party that can affect or be affected by the actions of the NSB relating to strategic management, corporate governance, business purpose and corporate social-responsibilities. Stakeholders include parties with the most direct and obvious interests in the actions of the NSB, such as customers and employees, 3) Refer to UNIDO Guide on Quality Policy at https://www.unido.org/sites/default/files/ files/2018-06/QP_PRACTICAL_GUIDE_08062018_online.pdf. 14 – ISO publication on Good Standardization Practices as well as others who are less obvious, such as third parties that are affected economically, yet have no influence over that effect. NOTE : In the latest revision of ISO/IEC 59, the terms stakeholder and interested party are considered as the same. In this publication, the difference is still main- tained in order to differentiate between the broader stakeholder groups that would not of necessity be directly involved in the development of standards, but which are nevertheless affected by the implementation of a standard. ISO publication on Good Standardization P ractices – 15 2. Standardization fundamentals ISO publication on Good Standardization P ractices – 17 2.1 The history of standardization Standardization has a very long history, dating back thousands of years. What started as a necessity to organize life in early civilizations was later used as a tool by rulers to enhance their power. The industrial revolution provided the real impetus for the growth of standardization, and even today, socio-political considerations give rise to standardization efforts. 2.1.1 Early beginnings Primitive societies lived in communities according to rules passed on from gen- eration to generation. This led to the development of language and writing. To establish a system of measurement, lengths from parts of the body were used. The ell, which is often mentioned in old writings, is the distance from the elbow to the tip of the long finger. The length of the foot and the breadth of the hand were other convenient measurements used. An early reference to standardization is found on the statue of Gouda, King of Chaldea, in which the sculptor extols the virtues of the ruler and praises him for the introduction of standards in the building industry. Other early accounts of building standards are found on the Egyptian frieze of Thebes dating from BCE 1450 ; this shows brick-building and measurements. During the reign of the first Roman Emperor Augustus (BCE 27 to 14 CE), the Romans published the Ten Books of Architecture. In these, for example, the rules and specification for meas- urements and proportions for the spacing of pillars and how to pile them, were described comprehensively. In the Middle East, various weight measurements were in common use for trade and paying tributes. In Babylonian times, typical weight measures were a Talent (30 kg), a Mina (500 g) and a Shekel (50 g). Around BCE 700, for example, King Hezekiah of Judah had to pay King Sennacherib of Assyria 300 Talents of silver and 30 Talents of gold as tribute for not invading Jerusalem. 18 – ISO publication on Good Standardization Practices 2.1.2 Standardization as a political tool Standards have been utilized extensively to further political goals. Qin Shi Huang, first emperor of China (BCE 220-210) unified China economically by standardizing the Chinese units of measurements such as weights and meas- ures, the currency, and the length of the axles of carts to facilitate transport on the road system. In early European history, it is believed that King William the First of England (1028-1087) published a Royal Decree that led to the beginnings of a unified system of measurement in England. Before his time, the units of the ell and foot were frequently based on measurements of a king himself. Once he was replaced by a new king, the measurements also changed. Historians believe that later kings decreed that there should be a standardized measurement of the unit length, the yard, which consisted of three feet, and the foot itself would comprise twelve inches. The inch was the length of three barley corns ; in so doing, kings had set standards for measurement and calibration. The early English system evolved into the British Imperial system of weights and measures. Yet now, almost a millennium after King William the First’s time, the standardised, metric system of measurement has largely replaced the Imperial system. Regarding the origins of the metric system, many historians believe that its originator was a French pastor, Gabriel Mouton, who in 1670, developed the idea of a logical, simple system based on multiples of ten. One hundred and twenty years later, the French National Assembly asked the French Academy of Science to develop a new, standardised system for units of length, volume and weight. The result was the beginnings of a unified system that found universal appeal. The new system not only replaced thousands of variants of measurement used throughout the French Republic, but also helped to enshrine the power of the government and enhance trade. The metric system eventually became an inter- national system, established by an international treaty, the Metre Convention in 1875. The metric system under the Metre Convention developed continuously with the addition of further measurement units, and in 1960, the SI System of coherent units was established by the 11th General Conference on Weights and Measures. ISO publication on Good Standardization P ractices – 19 2.1.3 Standardization in industrial development The industrial revolution greatly advanced standardization as manufacturers tried to deal with unnecessary varieties of manufactured goods, leading to problems with interchangeability, and unnecessary costs. Health and safety issues also started to have an effect on the industry, as products such as pressure vessels failed and caused many fatalities. Standards coupled with legislation became the main instruments to solve such problems. When the industrial revolution started in Britain, screw threads were already used extensively in manufacturing. The problem was that each manufacturer had its own system – there was no interchangeability. So in 1841, Joseph Whitworth, an English inventor, engineer and entrepreneur, proposed a standardized system for screw threads. Many railway companies then adopted this system, which eventually became a British Standard. The system of screw threads is named after Whitworth. Across the Atlantic, early train travel in America was hampered by a lack of a standard gauge for railways, meaning that trains had to be frequently unloaded and reloaded because the track gauge was different between cities. During the Civil War, the US government recognized both the military and economic advantages of having a standardized track gauge. The government then worked with railway companies to promote the use of the most common railway gauge in the US at the time, which measured 4 feet 8½ inches. This gauge was mandated for use in the Transcontinental Railroad in 1864 and by 1886, this gauge had become the US standard. At the beginning of the 20th century, every electrical company worldwide uti- lized its own standards for electrification. This in turn meant that voltages and symbols were totally different. The British engineer, inventor and industrialist, Rookes Evelyn Bell Crompton, recognised the inherent dangers of such chaos, so he worked tirelessly to ensure that harmonized standards were established. His work eventually led to the formation of the International Electrotechnical Commission (IEC) in 1906. 20 – ISO publication on Good Standardization Practices 2.2 Benefits of standardization There are many benefits of standardization for the private sector, the public sector and consumers. The use of standards in international and local trade and everyday life is now commonplace and well embedded ; so much so, that socio-economic systems without standards are not conceivable. 2.2.1 Standards and the private sector The many benefits that standards bring to the private sector include : ▸▸ Reduction in production and transaction costs : This is achieved mainly through variety reduction and rationalization of processes leading to econo- mies of scale. An additional benefit is that a broader choice of sub-suppliers of components and sub-assemblies is possible, all complying with the set standards ; ▸▸ Increased market opportunities : Many goods in numerous markets have become standardized. Hence, compliance with such standardized goods pro- vides the manufacturer with the opportunity to access more markets, instead of being limited to one where a different standard is expected ; ▸▸ Competitive positioning : Being involved in standards development allows manufacturers and suppliers to anticipate market developments. Progressive companies leading technological developments in the marketplace, may see their company standards become the basis for national or even International Standards, further enhancing their position in the market ; and ▸▸ Improved risk management : The risks associated with the introduction of technical regulations or the introduction of new technologies can be mitigated by the appropriate use of standards. Technical regulations based on known, proven standards lower the risk of non-compliance when a new technical regulation is published. The introduction of new technologies in the marketplace brings about inevitable costs ; however, these costs can be shared with other manufacturers if the new technology is codified in stand- ards that everybody can use. ISO publication on Good Standardization P ractices – 21 2.2.2 Standards and the public sector As well as specifying standards for government purchases, the public sector can benefit substantively from the use of standards, namely : ▸▸ A basis for regulation : Standards are recognized solutions to implement the health and safety requirements for regulated products. Legislators, for exam- ple, gain the acceptance of stakeholders for regulations because they were involved in the development of the standards used as the basis for regulation. Standards are kept up-to-date through five-year review programs ; hence regulations using them as a basis can remain up-to-date as well depending on the mode of referencing 4) ; ▸▸ Efficient regulation through participatory processes : When regulations are based on standards, these can be used to provide guidance on essential requirements. This has the advantage that market forces can be utilized in keeping compliance costs to a minimum. Conformity-assessment service providers complying with standards such as ISO/IEC 17021 and ISO/IEC 17025 can be designated by the country to provide such services. If more than one service provider is designated, market forces will keep costs at reasonable levels, and the country need not provide such services ; and ▸▸ Contribution to socio-economic development : Regulations based on standards give the country access to the latest state-of-the-art requirements for products agreed by a broad stakeholder group. In addition, local compa- nies can gain easier access to foreign markets where the regulations are also based on the same standards ; this means that such companies do not need to develop products that have to comply with a different set of standards. 2.2.3 Standards and the consumer The consumer benefits from standardization in several ways, such as : ▸▸ Consumer involvement : The consumer is invited to be a participant in the standards-development process ; hence the consumer has a voice in the process. Once products and processes are marketed, whether they 4) Standards can be referenced dated or undated – see Section 3.4.1 for details. 22 – ISO publication on Good Standardization Practices need to comply with technical regulations or not, standards are useful in a legal sense when dangerous or non-compliant consumer goods have to be identified ; ▸▸ Consumer safety : Products from many suppliers complying with the same underlying safety or compatibility standards provide the consumer with choices regarding other elements such as cost and design. This in turn means that consumers can be secure in the knowledge that the product will be safe and will integrate with common systems such as power supplies, telecommu- nications standards, the internet and common forms of machinery ; and ▸▸ Sustainability : Standards are widely used in occupational health and safety systems, environmental protection and increasingly in determining the social aspects of sustainable development, ultimately benefitting the society. 2.2.4 Standards and small-to-medium sized enterprises (SMEs) There is a perception that it is both difficult and expensive to comply with Interna- tional Standards, especially for small-to-medium sized enterprises (SMEs), which constitute the bulk of the industry in many developing countries. However, the benefits that SMEs can achieve if they pursue the implementation of International Standards, either directly or as an adopted national standard, are widespread. For example, International Standards : (i) help improve the quality of goods and services ; (ii) help to drive growth, cut costs and increase profits ; (iii) give the business a competitive edge ; (iv) open up markets for goods and services of SMEs ; (v) open the door for new customers and strengthen the existing business ; (vi) help SMEs to compete with bigger enterprises ; (vii) enhance the credibility of SMEs ; (viii) sharpen business practices and increase efficiency ; (ix) strengthen market- ing activities, and (x) help SMEs to comply with technical and other regulations. ISO has published a free brochure 5) listing and discussing these benefits, and ISO recommends that NSBs promote this document. 5) https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100283.pdf. ISO publication on Good Standardization P ractices – 23 2.3 Definition of a standard There are two definitions for a standard that are commonly utilized by practition- ers. These are the definitions contained in ISO/IEC Guide 2 : Standardization and related activities — General vocabulary, and the WTO TBT Agreement. Both are relevant, even though they differ ; the ISO/IEC Guide 2 definition is generally used in this publication. The difference between the ISO/IEC Guide 2 and the WTO TBT Agreement definitions is explained in Section 3.3. The definition of a standard given in ISO/IEC Guide 2 is the following : ▸▸ A standard is a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. NOTE : Standards should be based on the consolidated results of science, technol- ogy and experience, and aimed at the promotion of optimum community benefits. 2.4 Diversity of standards There are numerous ways to classify the many types of standards published by public and private organizations, and even non-governmental organizations (NGOs). A useful approach is to consider the classification as an environment with three facets, namely (i) technical content, (ii) development process, and (iii) legal status as shown in Figure 2.1. 2.4.1 Technical content The technical content includes elements such as the purpose, the type of document and the requirements contained within the standard. As regards the purpose of a standard, this is wide-ranging and includes subject areas such as basic terminol- ogy, specifications for products, processes and services, testing, and ; interface and data management. Standards can also be a combination of these types depending on their scope and envisaged use. 24 – ISO publication on Good Standardization Practices Standards, depending on their content, are not always called standards. In many cases, standards are also known as specifications, methods, guides, technical reports or code of practice, i.e. types of standards as defined in ISO/IEC Guide 2. Some are a vocabulary list or a classification of a product or service type. This is to some extent dependent on the custom and practice of the standards body and country. Standards can also be classified in terms of the requirements contained within them. Two main types are commonly recognized, namely design standards and standards that contain performance requirements. These two types of require- ments need not be dealt with in separate standards, as such requirements can also be combined in one standard. 2.4.2 Development process The development process addresses two important elements, which are (i) the principles of standardization, and (ii) the organizations which are developing the standards. These principles include transparency and consensus, which apply to the development of national, regional and International Standards. They are discussed in detail in Section 4. Secondly, there are numerous organizations developing standards, ranging from companies, consortia and industry in the private sector, to national, regional and international organizations. The latter three constitute the bulk of the international standardization system, required by the WTO TBT Agreement to follow its principles and requirements for standards development. There are also NGOs with specific socio-economic or environmental goals that develop and publish standards. ISO publication on Good Standardization P ractices – 25 Technical content Purpose ▸▸ Basic standard ▸▸ Process standard ▸▸ Terminology standard ▸▸ Service standard ▸▸ Testing standard ▸▸ Interface standard ▸▸ Product standard ▸▸ Data standard Type of document ▸▸ Specification ▸▸ Vocabulary ▸▸ Method ▸▸ Code of Practice ▸▸ Guide ▸▸ Classification Requirements ▸▸ Design standard ▸▸ Performance standard Development process Development process principles ▸▸ Openness ▸▸ Consensus ▸▸ Transparency ▸▸ Effectiveness ▸▸ Impartiality ▸▸ Relevance Organization ▸▸ Company ▸▸ Intergovernmental ▸▸ Consortium organization ▸▸ Industry sector ▸▸ National standards body association ▸▸ Regional standards body ▸▸ Non-Governmental ▸▸ International standards Organization body Legal status Voluntary ▸▸ The WTO TBT Agreement definition considers standards voluntary in respect of their application Mandatory ▸▸ The WTO TBT Agreement considers mandatory application of a standard to be a technical regulation Source: ISO NOTE: For definitions of the above see ISO/IEC Guide 2. Figure 2.1 : The standards environment 26 – ISO publication on Good Standardization Practices International Standards bodies Numerous bodies have been established to develop and publish International Stand- ards ; there are more than 50 such organizations. Six of these are generally consid- ered to have a wider influence than many of the other more specialized International Standards bodies. The WTO TBT Agreement applies to products and the three major organizations dealing with such standards include the IEC, ISO and International Telecommunication Union (ITU). As regards the WTO Sanitary and Phytosanitary Measures Agreement (SPS), the food, plant and animal-related trio standardization bodies, the Codex Alimentarius Commission (CAC), the International Plant Protec- tion Convention (IPPC) and World Organization for Animal Health (OIE) are the most important and are specifically mentioned in the WTO SPS Agreement. The following facts about bodies that develop International Standards are noteworthy : ▸▸ The International Electrotechnical Commission (IEC) is an NGO, established in 1906, has its head office in Geneva and publishes International Standards for electrical and electronic goods and systems. Its members are the IEC National Committees in the relevant countries and there is only one member per country ; ▸▸ The International Organization for Standardization (ISO) is an NGO, established in 1947 with its head office in Geneva and it publishes wide-rang- ing International Standards for scopes generally not handled by the others in this list. Its members are the foremost standards organizations in their countries and there is only one member per country ; ▸▸ The International Telecommunication Union (ITU) is an inter-governmen- tal organization belonging to the United Nations family, was established in 1897 with its head office in Geneva and it publishes International Standards for the telecommunications domain. Its membership comprises nearly 200 countries and almost 800 private-sector entities and academic institutions ; ▸▸ The Codex Alimentarius Commission (CAC) is an inter-governmental organization belonging to the United Nations family, established in 1963 with its head office in Rome and it publishes International Standards for food products, sometimes in co-operation with others, e.g. ISO. Its membership consists of nearly 190 countries ; ISO publication on Good Standardization P ractices – 27 ▸▸ The International Plant Protection Convention (IPPC) is a multilateral- treaty organization within the United Nations family, established in 1951 with its head office in Rome and it publishes International Standards for plant protection. Being founded by an international convention, it does not have members as the others, but contracting parties, i.e. countries that have acceded to the convention ; and ▸▸ The World Organization for Animal Health (OIE) is an inter-governmental organization outside the United Nations family, established in 1924 with its head office in Paris and it publishes International Standards for animal health. It has a membership of just over 180 countries. In the ITU, CAC, IPPC and OIE, all members have equal status. In the case of ISO and IEC, various levels of membership are possible with full membership being the highest level. Other membership grades such as associate or corresponding membership have fewer privileges. Full membership is required to participate in the governance of ISO and IEC, and the same applies largely to ISO/TCs. There are differences between the organizations in the way in which the technical work on the formulation of standards is undertaken by their ISO/TCs. ISO, IEC and CAC operate a decentralised system whereby member bodies are given full responsibility for specific ISO/TCs, whereas IPPC, ITU and OIE work with expert level meetings managed by the Secretariats. All of them however, meet WTO requirements for International Standards. The International Standards bodies cooperate closely in many areas to limit overlaps to a minimum, an issue that is becoming more important due to technology convergence. There are also formal cooperation agreements between International Standards bodies and certain regional standards bodies, e.g. ISO and CEN, and IEC and CENELEC. Regional standards bodies (RSBs) Two main types of regional standards-bodies (RSBs) have developed over the years, namely : ▸▸ RSBs established through political processes aligned with the regional trade arrangements, e.g. common markets and free-trade zones ; or 28 – ISO publication on Good Standardization Practices ▸▸ RSBs established as a voluntary organization within given geographical regions, e.g. Africa and the Pacific rim. In both cases, RSBs may publish regional standards developed through their own TCs, or it could just be a forum whereby harmonization of standards across the region is facilitated amongst the member states, i.e. no regional standards are developed and published. Well-known RSBs publishing regional standards include CEN, CENELEC and ETSI in the European Union. For the first type of RSBs, NSBs of the region may have an obligation to participate actively in the development of regional standards through regional TCs. These regional standards may be published as official regional standards or just provided to NSBs for adoption as national standards. In either case, NSBs have to adopt regional standards as national standards within a given time period and with- draw any conflicting national standards. Typical examples are the EN Standards (European Union) and EAC Standards (East African Community). In the second type of RSBs, the members are also NSBs, but membership is normally of a voluntary nature or by invitation. Typical examples are the African Organiza- tion for Standardization (ARSO), the Caribbean Community Regional Organization for Standards and Quality (CROSQ) and the Pan American Standards Commission (COPANT). Some of these would establish technical committees (TCs) to develop regional standards, but many operate as a forum where regional standardization issues can be discussed and harmonization of national standards of member states facilitated without reverting to the publication of regional standards. National standards bodies Many countries have established centralised NSBs in the past hundred years, even though a few countries have followed a more decentralised approach. Their organizational status can range from a government department, an organization of public law (i.e. a statutory body) or an organization of private law (i.e. either a “ not-for-profit ” or “ for-profit ” organization). The exact breakdown of the types is not known as no current common database exists in this respect, but details ISO publication on Good Standardization P ractices – 29 regarding individual NSBs can be found on their websites 6). Government depart- ment type NSBs seem to be the majority, with NSBs as organizations of public law second, followed by private sector NSBs. NSBs primary responsibilities include the development and publication of national standards, the provision of standards related information, and liaison with regional and international standardizing bodies. Many NSBs also provide standards related services such as inspection, testing, certification and training 7).. In fulfilling their primary responsibilities, NSBs should follow GSP. An important point for any NSB, irrespective of its organizational status, and whether it provides conformity assessment services or not, is that its standards development pro- gramme should function without undue political interference, i.e. its impartiality should be ensured. Industry sector and NGO-type standards organizations A vast array of normative documents is classed under the generic label of private standards. Generally, a normative document developed and published by an organization outside of the recognized standards development organizations at national, regional or international level is considered to be a private standard. There is not only a vast range of private standards (and growing in number), there are also significant differences between the bodies and organizations that develop these standards related to such aspects as governance, development approach, stakeholder engagement, transparency, and consensus 8). There are several reasons for the growth of private standards, such as : ▸▸ The time-to-market for International Standards would be at least two to three years, and that is too long for the sponsors of a standard in fast moving technologies, who then develop a private standard amongst themselves in a much shorter time. 6) The ISO membership list is a useful point of departure for accessing NSB websites. This can be accessed from the ISO website. 7) More detail is provided in the ISO publication Financing NSBs: Financial sustainability for National Standards Bodies obtainable from the ISO Secretariat. 8) These aspects are discussed in detail in Section 4 Principles for the Development of Standards. 30 – ISO publication on Good Standardization Practices ▸▸ Consortia develop a private, product standard to gain a market advantage over rivals. ▸▸ Global-brand producers and retailers increasingly require their suppliers to comply with certain social, environmental and safety requirements as they respond to pressures from their customers. These requirements are then for- malised within private standards, guidelines or principles that their suppliers have to comply with contractually. ▸▸ NGOs wishing to promote specific social and environmental changes then developing private standards and establishing certification schemes to sup- port their goals. ▸▸ Multinational certification-bodies identifying a specific market niche, developing a private standard and implementing a certification scheme as a sound business-proposition. Whatever the reasons for developing a private standard, these reasons have become an important factor in accessing the developed markets of Europe and the USA, and they are also spreading into the markets of Asia. A final – but still embryonic – trend relates to the harmonization and benchmarking of private standards as a response to the overwhelming growth in their number and variety, and pressures from suppliers on purchasers to harmonize requirements. Furthermore, despite the multiplicity of private standards, new ones continue to emerge frequently. Legal status The WTO TBT Agreement is very clear in that standards are considered to be volun- tary in their application, whereas technical regulations are mandatory. This has led to some confusion in the understanding of the use of standards in contracts. Clearly conformity with standards used in contracts has to be fulfilled by the sup- plier, but non-compliance would be an issue dealt with under civil law. It is not considered to be an offence in terms of public law as is the case for non-compliance with a technical regulation. Another issue that has to be considered, is that national standards have to be given legal standing in many jurisdictions, otherwise they cannot be referenced in technical regulations or their copyright cannot be protected. Even though they ISO publication on Good Standardization P ractices – 31 are promoted as national standards in terms of legislation and are considered as a legal document at the national level, their application remains voluntary in terms of the WTO TBT Agreement definitions. 2.5 Users of standards The users of standards can be found in all constituents that make up a country and in all levels of society. They range from industry and commerce, government, consumers, labour, academic and research organizations, conformity assessment service providers and non-governmental organizations (NGOs). 2.5.1 Industry and commerce Standards are used widely in industry and commerce in the complete product value-chain. This starts with the product design, continues with the purchasing of raw materials, through production and inspection, and includes packaging. Even marketing and after-sales service make a significant use of standards. To ensure consistency of production and supply, the management systems can be aligned with standards, for example such as ISO 9001 for quality-management systems and ISO 14001 for environmental-management systems. 2.5.2 Purchasers and consumers Purchasers make extensive use of standards in their purchasing contracts and deci- sions. Bulk purchasers, e.g. large companies or the country’s purchasing agency, utilize standards as a contractual requirement for the supply of bulk purchases. These are frequently coupled with compliance to quality management standards such as ISO 9001. Consumers , on the other hand, use well-known product certification marks in their purchasing decisions or rely on test results published by independent test organizations. Anecdotal evidence suggests that more expensive products such as televisions are more likely to be chosen this way, than every-day, inexpensive consumables such as soap or toothpaste. Here advertising plays a much bigger role. 32 – ISO publication on Good Standardization Practices 2.5.3 Conformity assessment service providers Conformity-assessment service-providers utilize the same standards that pur- chasers typically demand In addition, these service providers have to comply themselves with International Standards such as ISO/IEC 17020, ISO/IEC 17021-1, ISO/IEC 17025, and ISO/IEC 17065, in order to be recognized as competent bodies. Many NSBs provide conformity-assessment services such as inspection, testing and certification, even though the bulk of such services in the more advanced economies is provided by private sector entities. As a matter of principle, NSBs should ensure that their standardization activities are independent of other activi- ties such as conformity assessment, where this is the case. 2.5.4 Organizational and product innovators Innovation is defined by the Oslo Manual of the Organization for Economic Coop- eration and Development (OECD) as “ the implementation of a new or significantly improved product (good or service) or process, a new marketing method, or a new organizational method in business practices, workplace organization or external relations ”. Others consider innovation as the development of completely different technology that revolutionizes the economic structure from within by disrupting or totally replacing old technology, e.g. cell-phones replacing landlines, and digital photography replacing film-based photography. In an age of ever faster technological developments, innovation is widely recog- nised as one of the essential drivers of successful businesses and a key contributor to the productivity and socio-economic development of nations. Hence, in many countries, there is a strong focus on public funding of research and development and on intellectual property rights as instruments of innovation policy and busi- ness strategy. The International Standards of the ISO 56000 series on innovation management can provide guidance in this respect. The driver for innovation programmes in organizations should be to achieve growth, because organizations cannot grow through cost reduction and re- engineering alone. Typical goals of innovation in manufacturing and services ISO publication on Good Standardization P ractices – 33 organizations could include : (i) Improved quality ; (ii) extension of the prod- uct range ; (iii) reduction of labour costs ; (iv) improved production processes ; (v) reduction in material costs ; (vi) reduction in the environmental footprint of the organization ; (vii) replacement of products ; (viii) reduced energy consumption ; and (ix) compliance with regulatory requirements. Looking at the above goals of innovation and mapping them against the quality- infrastructure services, it quickly becomes apparent that almost all of them would benefit from the appropriate and robust use of standards, metrology, accreditation and conformity assessment. 2.6 Quantifying socio-economic benefits of standardization One of the key aspects of the mission of NSBs is to liaise with organizations from all stakeholder groups to engage them in standardization and to help them get the most from standards. Yet, whereas the people involved in standardization under- stand that their work generates considerable benefits for organizations, markets and society, it is important that they convey this point of view to industrialists, public administrations and other opinion leaders. In order to substantiate and quantify the real-world value of voluntary standards, ISO has developed the ISO Methodology ; this is a consistent approach to measuring this value, which has been tested in approximately 30 case studies for companies in over 20 countries across the globe. The results speak for themselves : standards do create value for the organizations that use them, and it is feasible to quantify the many benefits. 2.6.1 Assessment steps at the company level To be able to apply the ISO Methodology, users can download a manual containing detailed steps to do so from the ISO Website 9). Figure 2.2 illustrates the ISO Meth- odology and it consists of the following stages : 9) http://www.iso.org/iso/home/standards/benefitsofstandards/benefits_of_standards.htm. 34 – ISO publication on Good Standardization Practices ▸▸ Understand the company’s value chain : The ISO Methodology is based on the value chain, which subdivides the operations of a company into a num- ber of key business-functions that, in turn, group together certain activities. The value chain of the company then needs to be understood in terms of its key business processes and its core value-adding activities. ▸▸ Identify the impact of standards : The second step consists in determin- ing the business functions and activities in the company value chain where standards play a significant role. Existing company documentation (e.g. the quality manual, process and organizational charts, other corporate or depart- mental documentation) could be used to understand the processes, business functions and main activities included in each business function. ▸▸ Analyse the drivers and determine operational indicators : This step analyses the company value drivers (i.e. its competitive strengths) and determines the operational indicators that will be applied to measure the impacts of standards. The impacts of standards closely associated with value drivers will have a significant higher effect on value creation, and they should be considered in the first instance. Thereafter, one or more operational indicators associated with these value drivers should be identified to actually quantify the impacts. These could be company activities that show improve- ment or degradation of performance (e.g. time and cost, number of defects, waste, sales, and customer satisfaction). ▸▸ Assess and calculate the results : The purpose of the complete assessment process is to : a) quantify the impacts of standards using the operational indicators and aggregate these impacts for each of the selected business functions ; b) convert the quantities resulting from the use of standards for each of the selected business functions into financial figures ; and c) add the figures for all the selected business functions at a given point in time to determine the total contribution of standards to the company gross profit or EBIT (Earnings Before Interest and Tax). ISO publication on Good Standardization P ractices – 35 Understand the value chain ▸▸ Clarify industry boundaries ▸▸ Analyze the company value chain ▸▸ Identify the most relevant business functions Identify the impacts of standards ▸▸ Identify and list standards used by the various business functions of the company ▸▸ Identify impacts deriving from standards for main business functions and activities associated with these functions Analyze the value drivers and key operational indicators ▸▸ Identify value drivers to focus assessment on the most relevant standards impacts ▸▸ Select relevant performance indicators, possibly linked to value drivers, to identify major impacts of standards on the business functions in scope Measure the impacts of standards ▸▸ Quantify most relevant standards impacts ▸▸ Calculate Earnings Before Interest and Tax ▸▸ Impact for each standard ▸▸ Consolidate the results Figure 2.2: Quantifying benefits of standardization at company level 36 – ISO publication on Good Standardization Practices 2.6.2 Case study results Published case-studies span enterprises of varying sizes, from small companies of 25 employees with an annual sales revenue of approximately USD 4.5 million to large conglomerates of several thousand employees with an annual revenue exceeding USD 2.5 billion. Despite the huge differences in size, results consistently demonstrate that companies achieve tangible benefits from using standards. Some key benefits reported include : ▸▸ Streamlining internal operations : Standards can be used to streamline the internal processes of a company, for example by reducing the time needed to perform specific activities in the various business functions, decreasing waste, reducing procurement costs and increasing productivity. The case studies consistently report that the contribution of standards to the gross profit of companies ranges between 0.15 % and 5 % of the annual sales revenues. ▸▸ Innovating and scaling up operations : Some case studies provide exam- ples where standards served as the basis for innovating business processes, allowing companies to expand their suppliers’ network or to introduce and manage new product lines effectively. In other examples, standards helped companies to mitigate the risk of introducing new products into national markets. ▸▸ Creating or entering new markets : Standards have been used as the basis for developing new products, penetrating new markets (both domestic and export), supporting the market uptake of products, and even creating mar- kets. In exceptional cases, the impact of standards far exceeded the figures mentioned above, with companies achieving a gross profit contribution of up to 33 % of their annual revenue. This in turn helped the companies to position themselves as leaders in their field, at least over a certain period of time. 2.6.3 Other case study information In addition to the ISO methodology and its results described in 2.6.1 and 2.6.2, ISO also developed a Web page that contains information on studies on the economic ISO publication on Good Standardization P ractices – 37 and social benefits of standards for trade, national economies, industry sectors, individual companies and citizens 10). It is intended as a reference work of studies that address economic and other benefits of standards, their impacts and their relevance for international trade, innovation and economic development. The studies have been undertaken by different authors, such as national and Interna- tional Standards bodies, research institutes, universities and other international agencies. The Web page is updated continuously to ensure that the information remains up-to-date as far as possible. 10) https://www.iso.org/sites/materials/benefits-of-standards/benefits_repository.html. 38 – ISO publication on Good Standardization Practices 3. The WTO and standardization ISO publication on Good Standardization P ractices – 39 The WTO Agreement on Technical Barriers to Trade (WTO TBT Agreement) is likely to be the most influential international legal text on standardization. The Agree- ment prescribes the principles for standards, conformity assessment procedures and technical regulation development and their implementation, and all WTO members must comply with it. There are very few countries left in the world that are not members of the WTO ; hence the majority of the world’s nations need to comply with the Agreement. This has profound implications on virtually every national standards body. The same would apply to every regional and international standardizing body. 3.1 World Trade Organization (WTO) The WTO is an intergovernmental organization which regulates international trade. The WTO endeavours to facilitate trade between participating countries by providing a framework for negotiating trade agreements and a dispute resolution process. These activities are aimed at enforcing participants’ adherence to WTO agreements, which are signed by representatives of member governments and ratified by their parliaments. Most of the issues that the WTO focuses on derive from previous trade negotia- tions, especially from the Uruguay Round of the General Agreement on Tariffs and Trade (1986–1994). The WTO oversees about 60 different agreements and decisions which have the status of international legal texts. Countries must accede to all WTO multilateral agreements when they join the organization. From a standards and technical regulation perspective, the two important agree- ments negotiated during the Uruguay Round, and which entered into force with the establishment of the WTO, are : ▸▸ The Agreement on Technical Barriers to Trade (WTO TBT). This agreement seeks to ensure that technical regulations and standards, as well as testing and certification procedures for their implementation, do not create unneces- sary obstacles to trade ; and 40 – ISO publication on Good Standardization Practices ▸▸ The Agreement on the Application of Sanitary and Phytosanitary Measures (WTO SPS). This agreement encourages members to base their food safety and animal and plant health regulations on International Standards. 3.1.1 Trade barriers in the WTO TBT Agreement Trade barriers consist of two types, namely tariff and non-tariff barriers (NTBs). NTBs refer to restrictions that result from prohibitions, conditions, or specific market requirements that make importation or exportation of products difficult and/or costly. NTBs arise from different measures taken by governments and authorities in the form of laws, regulations, policies, conditions, restrictions or specific requirements, and private sector business practices, or prohibitions that protect the domestic industries from foreign competition. NTBs comprise technical (such as standards, technical regulations, sanitary and phyto-sanitary measures or environmental protection measures) and non-tech- nical measures, such as quotas, price controls, exports restrictions, or contingent trade protective measures. Other types of NTB include behind-the-border measures, such as competition, trade-related investment measures, government procurement or distribution restrictions. The WTO TBT Agreement deals specifically with a number of the technical NTBs, namely to ensure that technical regulations, standards, testing, and certification procedures do not become unnecessary barriers to trade. The agreement prohibits technical requirements created in order to limit trade, as opposed to technical requirements created for legitimate purposes such as health and safety of the population, and consumer or environmental protection. It is therefore a balancing act between free trade and the legitimate responsibility of governments to protect their society and environment against unsafe or fraudulent products. To this end it promotes the use of International Standards. ISO publication on Good Standardization P ractices – 41 3.1.2 Scope of the WTO TBT Agreement The WTO TBT Agreement applies to all products, even those of agricultural origin. This is important to understand as there is a perception by some, that food products fall only under the WTO SPS Agreement. The WTO TBT Agreement and WTO SPS Agreement are mutually exclusive by definition, i.e. a measure within the scope of the WTO SPS Agreement that is not subject to the WTO TBT Agreement. The scope of the WTO SPS Agreement covers only very specific issues and are clearly defined. Hence, a product can be subject to requirements of both the agreements, depending on the measures. Typical WTO SPS measures include : food standards that are enforced by govern- ments to ensure the safety of food, and ; biosecurity controls that are enforced at international borders to keep out exotic animal pests, plant pests and diseases. Anything else falls under the scope of the WTO TBT. For example, residues of veterinary drugs or pesticides in food or drink would be an SPS measure, whereas the labelling on the composition of the same food or drink would be a TBT issue. The WTO TBT Agreement also does not apply to purchasing specifications prepared by governmental bodies for production or consumption requirements of govern- mental bodies. They are addressed in the Agreement on Government Procurement. 3.1.3 Legitimate objectives of the WTO TBT Agreement The WTO TBT Agreement lists the objectives for which technical regulations can legitimately be implemented. These include : the protection of life and health of individuals, animals and plants ; and the protection of the environment. They also include the prevention of deceptive practices which would seriously affect consumers. However, the scope of the WTO TBT does not apply to the general quality of products, or the protection of the local industry. Some countries may consider protecting local industry from foreign competition as a legitimate policy. This is usually achieved through country specific manda- tory standards or technical regulations – in reality, these are disguised trade- barriers, e.g. the restrictions are not based on International Standards. Apart from 42 – ISO publication on Good Standardization Practices contravening WTO TBT rules, it is also a short-sighted strategy that will only result in the local industry becoming totally non-competitive over time. Such strategies should be avoided. 3.2 WTO TBT Agreement principles There are five principles that underpin the WTO TBT Agreement ; all of these are derived from the General Agreement on Tariffs and Trade (GATT). These have a large impact on all standardization activities. The Most Favoured Nation principle requires imported products from all WTO members to be accorded the same treatment. This means that governments must ensure that TBT measures do not discriminate between foreign producers (for example, by favouring one country over another). The National Treatment principle requires imported and domestic products to be treated in a like manner, i.e. imported products should not be subject to more stringent inspection and certification than local products. In developing countries, local manufacturers are sometimes subject to much higher conformity-assessment requirements through mandatory certification than imported products. This is a violation of the National Treatment principle in reverse – it puts local manufactur- ers at a disadvantage with regard to imported products. The Least-Restrictive-Means principle seeks to ensure that technical regula- tions should not be more restrictive to trade than necessary. However, technical regulations are, by their very nature, trade restrictive. The question is what is considered to be more restrictive to trade than necessary ? The evaluation would embrace several factors, including how much the measure contributes to the achievement of the objective, the types of risks and the potential consequences from the non-fulfilment of the objective, and the restrictiveness of the measure. If the objective is applied by the imposition of a technical regulation based on International Standards, then this principle is considered fulfilled even though this can also be challenged. The Transparency principle is a cornerstone of the WTO TBT Agreement. It is applied through the notification provisions, along with the relevant TBT Committee ISO publication on Good Standardization P ractices – 43 decisions and recommendations. These decisions and recommendations reveal how members intend to regulate, gives trading partners an opportunity to provide comments, thereby assisting in improving regulation. This in turn helps producers and exporters adapt to changing requirements. The Sham principle requires that standards, conformity-assessment procedures and technical regulations are not simply trade barriers in disguise. This easily happens when local manufacturers pursue the development of a national stand- ard that differs significantly to the International Standard, in order to protect themselves from unwanted competition from imported products. It also happens when governments erroneously consider protecting local industry against foreign competition, by creating technical regulations which differ from International Standards. Neither is good for the country’s industrial development in the long run, apart from contravening the requirements of the WTO TBT Agreement. 3.3 Standards and Technical Regulations Standards and technical regulations can look very much alike, thereby leading to confusion. That said, there are some very important differences as determined in the WTO TBT Agreement. The following sub-sections describes these differences. 3.3.1 Definitions The WTO TBT Agreement definitions for a technical regulation and a standard are very clear. The foremost difference is that compliance with a technical regulation is mandatory, whereas compliance with – or conformity to – a standard is not mandatory, unless the standard is embodied within a regulation. In contrast to the WTO TBT Agreement, ISO/IEC Guide 2 definitions do not prescribe compliance. 44 – ISO publication on Good Standardization Practices Technical regulation Document which lays down product or service characteristics or their related pro- cesses and production methods, including the administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. WTO TBT Agreement Regulation (document providing binding legislative rules, that is adopted by an author- ity) that provides technical requirements, either directly or by referring to or incorporat- ing the content of a standard, technical specification or code of practice. ISO/IEC Guide 2:2004 The WTO TBT Agreement definition of a technical regulation and that provided for in ISO/IEC Guide 2 differ in wording, but not in substance. The ISO/IEC definition does mention the way in which standards can be used as the basis of a technical regulation, whereas the WTO TBT Agreement definition does not. On the other hand, the WTO TBT Agreement itself is clear in that governments should utilize International Standards as the basis for the technical requirements of their tech- nical regulations. The WTO TBT Agreement definition of a technical regulation also includes administrative provisions, which are absent from its definition of a standard. ISO publication on Good Standardization P ractices – 45 Standard Document approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for products and services and related processes or production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling require- ments as they apply to a product, process or production method. WTO TBT Agreement Document, established by consensus and approved by a recognized body, that pro- vides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. ISO/IEC Guide 2:2004 The definition of a standard as contained in the WTO TBT Agreement, differs from that commonly quoted definition from ISO/IEC Guide 2. The ISO/IEC definition lists consensus as a principle of development and does not say anything about a standard being voluntary or not. It deals with products and services, whereas the WTO definition only considers products and their production methods, because that is the scope of the Agreement. The WTO TBT Agreement definition is very clear in that the application of a standard is considered to be voluntary, whereas the ISO/IEC definition does not mention anything about its legal status. Due to the impact of the WTO TBT Agreement, it is now generally accepted practice throughout the world that standards are con- sidered to be voluntary in their application, in contrast to technical regulations, which are mandatory. The narrow scope of the WTO TBT Agreement definition, however, is not generally used – whereas the scope of standards as accepted by practitioners is wide, and includes products, services, processes, and systems. A standard is developed by a recognized body in both definitions. The WTO TBT Agreement, however, is abundantly clear that the development of a technical regu- lation is a government responsibility. In terms of the WTO TBT Agreement, compli- ance with a standard is not mandatory. This wording has led to some discussion, 46 – ISO publication on Good Standardization Practices because if a standard is specified in a purchasing contract, then compliance is mandatory in terms of the contract. That said, non-compliance is then an issue of civil law, not an offence in terms of national legislation. To ascertain whether a technical regulation exists, WTO jurisprudence to date has established three criteria : (i) that the requirements (set out in the document containing the technical regulation) must apply to an identifiable product or group of products (even if this is not expressly identified in the document) ; (ii) that the requirements must specify one or more characteristics of the product (these may be intrinsic to the product itself, or simply related to it, and they may be prescribed or imposed in either a positive or a negative form) ; and (iii) that compliance with the product characteristics must be mandatory. Clearly, the WTO TBT Agreement definitions apply in considering the implementation of the Agreement, not the ISO/IEC definitions. 3.3.2 Committee on Technical Barriers to Trade The WTO TBT Agreement establishes a Committee on Technical Barriers to Trade, composed of WTO Members. This Committee affords WTO Members the oppor- tunity of consulting on any matters relating to the operation of the Agreement or the furtherance of its objectives, and most of these deal with standards, technical regulations and their implementation. Three specific objectives for the Committee are listed in the Agreement. Review of specific measures WTO Members/Observers use the TBT Committee to discuss specific trade-concerns (STCs) – specific laws, regulations or procedures that affect their trade, usually in response to notifications. Essentially, members raise STCs to find out more about the scope and implementation of each other’s regulations in light of the core TBT obligations. The discussion is mostly about measures under development but can also be about the implementation of existing measures. To date, more than 400 STCs have been raised, which can be accessed through the TBT Information ISO publication on Good Standardization P ractices – 47 Management System – the database of WTO information on TBT notifications, specific trade concerns, and enquiry points. Strengthening implementation of the TBT Agreement Members exchange experiences on the implementation of the Agreement, with a view to making implementation more effective and efficient. This discussion revolves around generic, cross-cutting themes, including transparency, standards, conformity assessment and good regulatory practice. These are frequently organ- ized in the form of a workshop held back-to-back with a TBT Committee meeting and have become an integral part of the calendar. Useful exchanges of information regarding standardization and the implementation of technical regulations have been generated over the years ; information about this is accessible through the WTO TBT Agreement Website. Triennial Reviews Once every three years, the Committee reviews the operation and implementation of the Agreement including the provisions relating to transparency, with a view to recommending an adjustment of the rights and obligations of this Agreement where necessary to ensure mutual economic advantage and balance of rights and obligations. Following such reviews, the Committee has developed a series of decisions and recommendations over the years intended to facilitate implementa- tion of the Agreement, some of which have a major impact on standardization. Documented Decisions of the TBT Committee include the following activities : ▸▸ Good Regulatory Practice ; ▸▸ Conformity Assessment Procedures ; ▸▸ Indicative List of Approaches to Facilitate Acceptance of the Results of Con- formity Assessment ; ▸▸ Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations ; ▸▸ Transparency ; ▸▸ Technical Assistance ; and ▸▸ Special and Differential Treatment. 48 – ISO publication on Good Standardization Practices Knowledge regarding these TBT Committee decisions should be an integral part of the implementation of GSP, and NSBs are recommended to familiarize themselves with these decisions. Too often they are considered part of the political world and not so important for the NSB – this is incorrect. The Decisions have a major impact on the standardization and other activities of the NSB. All of the above documented Decisions are accessible from the WTO TBT Agreement Website. 3.4 Technical regulations and SPS measures Technical regulations and SPS measures are complex largely due to many dif- ferences in approach in their development and implementation amongst WTO Members, in spite of the requirement that WTO members must comply with the requirements of the two Agreements. There is also confusion amongst some practi- tioners regarding the differences between technical regulations and SPS measures ; this requires explanation. 3.4.1 Technical regulation building-blocks In order to better understand the many different approaches to technical regu- lations, it is useful to consider their building blocks that can be derived from the definitions of a technical regulation and the text of the WTO TBT Agreement – see Figure 3.1. Anecdotal evidence would suggest, that if any of the building blocks are not properly provided for in the technical regulation, then it may prove to be ineffective. The building-block approach also highlights the importance of standards in the development and implementation of technical regulations. ISO publication on Good Standardization P ractices – 49 Self-regulation Policy Impact Awareness Assessment Education Technical Regulation Product/Process Legislation Administrative Characteristics Procedures Technical Conformity Regulatory Sanctions Requirements Assessment Authority Source: Author’s elaboration Figure 3.1: Technical regulation building blocks A government may contemplate implementing a technical regulation, once a product that has been marketed, is thought to be deleterious to the health or safety of people, the fauna and flora and the environment, or if it is considered a deceptive practice. Regulatory Impact Assessment (RIA) Before a technical regulation is considered, a regulatory impact assessment (RIA) should be conducted to determine the triggers for the regulation, the risks involved, the socio-economic costs and benefits of implementing the technical regulation, and whether the infrastructure to implement it exists in the country. This is also important in the case of standards being declared mandatory, thereby rendering them as technical regulations. Without a RIA to evaluate all aspects, a new technical regulation may lead to nega- tive impacts on the economy or society, or impacts that may not have been evalu- ated or even considered. The outcome of a RIA may be that a technical regulation 50 – ISO publication on Good Standardization Practices is not implemented, but that other less onerous measures are preferable. These would include self-regulation by the suppliers, or an awareness and/or education campaign to sensitize consumers. If the outcome of the RIA points towards the implementation of a technical regulation, then the rest of the building blocks have to be given appropriate attention. Legislation A technical regulation is, by definition, a legislative measure. Hence, its format should comply with national legislative practices and norms. Good practice would suggest that enabling legislation is the better way. Enabling legislation does not contain the details of a technical regulation, but provides the framework for sub- legislation, e.g. regulations promulgated by the government, that can be updated fairly rapidly. First-level legislation usually has to go through one or more levels of government, which can be a long and arduous process, making the updating of technical regulation that contains all the details a major challenge. Being able to put the details in sub-legislation helps authorities to be more flexible and timely in implementing technical regulations. Technical requirements The technical requirements of the technical regulation should be based on Inter- national Standards (or their national adoption) as indicated by the WTO TBT Agreement. A number of methods are listed below. ▸▸ The standards can be referenced in the regulation as : ▸▸ Undated references have the advantage that should the standard be revised, then the technical regulation is kept up to date. However, the responsibility for the technical regulation is assigned to a body other than the regulatory authority. ▸▸ Dated references have the disadvantage that should the standard be revised the technical regulation has to be updated. The responsibility, how- ever, remains with the relevant regulatory authority. The choice whether the reference is dated or undated will depend on the regulatory authority preferences and custom and practice of the country. Compliance with the ISO publication on Good Standardization P ractices – 51 standard then becomes a prerequisite for meeting the requirements of the regulation. Referencing standards is a concept that is followed widely in both the developed and developing economies. ▸▸ Standards can be published as deemed to satisfy regulation require- ments in a separate official list. In this case, compliance with the standard listed confers compliance of the product with the requirements of the regula- tion. This system has the advantage that other standards may also be used, but a sophisticated legal system is necessary to apply this approach. The EU Regulations and European (EN) standards are a well-known example of this practice where those EN standards, elaborated under a standardization request of the European Commission, provide the presumption of conformity with applicable EU Regulations (i.e. EU Directives). ▸▸ The technical requirements of the standard can be included in the text of the technical regulation. Even though legally acceptable, this is no longer considered good practice. Keeping the regulation up-to-date with rapidly moving technologies and changing standards is extremely challeng- ing, and often not effectively managed by regulatory authorities. The result is that such regulations become out-of-date, are not updated, and the supplier has to provide products complying with out-of-date requirements. This can render the technical regulation unsafe, or increase the transaction costs for the supplier, costs that the consumer ultimately has to bear. Furthermore, it should be noted that the copyright of standards organizations may be compromised with this practice. Conformity assessment Conformity assessment to prove compliance with the technical requirements of the regulation could be any combination of inspection, testing and certification. The conformity assessment can either be performed by the supplier (i.e. self- declaration of conformity) or by independent third parties whose competency is demonstrated by accreditation, and who are acceptable to the regulatory authority (e.g. designated, notified bodies). 52 – ISO publication on Good Standardization Practices Self-declaration of conformity (SDOC) presupposes ethical behaviour of the sup- pliers and effective product-liability legislation. Anecdotal evidence would suggest this is a major challenge in developing countries, which are often the target of dumping of non-compliant products. SDOCs are therefore seldom encountered in developing economies. In developed countries, SDOC is most often accompanied by some level of market surveillance. Developing-country regulators may prefer conducting their own conformity assess- ments, but this is costly to the country and is considered a barrier to trade by many. Hence, liberating the conformity assessment to include private-sector service- providers, providing their competency can be demonstrated (usually through accreditation), is the current best practice and can limit the transaction costs of compliance by the suppliers. Regulatory authority The regulatory authority is primarily responsible for in-market surveillance to ensure continued compliance of products with the technical regulation by all suppliers. In high-risk cases, pre-market approvals may be required as well. The regulatory authority has to initiate sanctions if suppliers do not meet requirements. The regulatory authority does not necessarily have to perform the conformity assessment of products but should accept the services of technically competent and designated service-providers. Sanctions The regulatory authority applies administrative sanctions such as directives for recall, rework or destruction of non-compliant products. If suppliers do not heed administrative sanctions, then courts of law may be required. 3.4.2 The WTO TBT and SPS Agreements The terminology of standards, technical regulations and SPS measures is frequently a source of confusion. Common usage of these terms does not always correspond with their legal meaning provided for in the WTO TBT and SPS Agreements. For ISO publication on Good Standardization P ractices – 53 example, many countries have food standards that are mandatory, whereas the WTO TBT Agreement considers a standard to be voluntary in nature. Furthermore, the legal status of a standard has a slightly different meaning in the WTO TBT and SPS Agreements. In the WTO TBT Agreement, a standard is purely voluntary, whereas in the WTO SPS Agreement, a food standard could be mandatory. Complementary but mutually exclusive It is important to understand that the WTO TBT and SPS Agreements are comple- mentary but mutually exclusive. A measure falling within the scope of the WTO SPS

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