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Articulos escogidos en Español
January 2005 Feature
Steven P. Cornish is employed by the American National Standards Institute (ANSI) as a director of international policy, where he focuses on the policy and governance issues of ISO. Cornish currently serves as the ANSI representative on the ISO Technical Management Board and a number of its subgroups. In his 15 years at ANSI, he has worked with U.S. interests on national, regional and international standardization in a variety of sectors including image technology, medical devices, safety and health, and the environment.
New ISO Policy Provides International Solutions to Market Needs

Anyone in the international business community would naturally assume that the International Organization for Standardization (ISO) develops standards that could be implemented anywhere in the world without special preference or hindrance to any affected party. Even the mission (1) of the organization calls for ISO to “develop and issue International Standards, and take action for their worldwide implementation.” Yet a number of recent cases have called into question whether specific ISO standards possess the desired international applicability.

Among the examples cited were a number of ISO standards dealing with ergonomics. Global implementation was hindered because the standards were based on anthropometric parameters appropriate to the populations in Europe and North America, but not appropriate to the populations in regions such as Southeast Asia. In another case, several countries that were moving forward with plans to nationally adopt the ISO standard for cigarette lighters (ISO 9994) found it necessary to revise the maximum permitted flame height because the value included in the ISO text was not suitable for use in their region – in this instance, specific tropical conditions.

When a standard is not being used, its relevance must be called into question. As a case in point, the ISO standard on metallic flanges (ISO 7005-1) was first published in 1992, but by the year 2000 the standard was not being used anywhere in the world. In contrast, the relevant European, North American and Japanese standards enjoyed comparable worldwide market shares. Thus, Japan proposed that the ISO standard be revised to reflect market reality through the development of what is often referred to as a “co-habitation standard.” Essentially, this means that the requirements in the three standards used worldwide will be incorporated into a single ISO standard and that users of the standard will be able to make selections according to the region and markets in which they wish to operate.

Another concern, and one that has been cited frequently, is that of perceived European dominance in ISO and the view that ISO standards are written to suit the European Union regulatory regime. Any undue influence from a particular region can lead to the development of an international standard that may not be suitable for implementation where the regulatory and legal regimes or embedded technology and practices may be different.

Six Guiding Principles of Global Relevance

The formation of the World Trade Organization, and the subsequent adoption of the WTO Technical Barriers to Trade Agreement, have placed new obligations on standards developing organizations. In essence, the international standards that these organizations develop, adopt and publish must support global trade and must be globally relevant. The development and adoption of an international standard that fails to meet WTO requirements is open to being challenged as creating a barrier to free trade (see sidebar below).

A globally relevant standard should:
Effectively respond to regulatory and market needs (in the global marketplace);
Respond to scientific and technical developments in various countries;
Not distort the market;
Have no adverse effects on fair competition;
Not stifle innovation and technological development;
Not give preference to characteristics or requirements of specific countries or regions when different needs or interests exist in other countries or regions;
Be performance-based as opposed to design-prescriptive.
Source: Document G/TBT/1/Rev.8, formerly referred to as Annex IV to the Second Triennial Review of the Technical Barriers to Trade Agreement

Upon consideration of the cases noted above, as well as the provisions spelled out by the WTO, ISO’s management bodies were compelled to provide fuller advice on global relevance to the ISO technical committees and subcommittees. Over a period of several months, and with intensive international cooperation and collaboration, ISO developed and approved a complete global relevance policy. The first step was the organization’s definition of global relevance as “the required characteristic of an International Standard that it can be used/implemented as broadly as possible by affected industries and other stakeholders in markets around the world.”

The new ISO Global Relevance Policy and Principles Document hinges on the six principles identified below. Further practical details are provided in an accompanying ISO Global Relevance Implementation Guidance Document.

Principle 1
The status and meaning of an international standard shall be respected.

Any ISO standard shall, to the extent possible, represent a unique international solution. If a single solution is not currently possible due to legitimate market and essential differences – factors such as legislation, climate, environment, economies, social conditions, trade patterns, etc. – then the resulting standards may present options to accommodate these differences.

Principle 2
The commitment to participate in the development and the feasibility of preparing international standards shall be demonstrated at the outset of a standards development project.

When various solutions exist in order to meet unique aspects of the local markets in different regions and countries, the evolution of a single global market can be hindered. However, imposing a single solution that accommodates the needs of one market, but not others, may force that market – and its related industries – to look elsewhere for a standard that better accommodate its needs. Educated decisions must be made.

ISO committees shall now ascertain at the outset of a project which of three possible options is feasible for the work at hand:

1. Develop an ISO standard that presents one unique international solution in all of its provisions;
2. Develop an ISO standard that presents options in specific provisions to accommodate existing and legitimate market differences where justified; or
3. Undertake no development work because the preparation of a globally relevant ISO standard is not feasible at the present time and under the present conditions.

Principle 3
Preference shall be given to preparing performance rather than prescriptive standards.

The use of the performance-based approach is widely recognized as supporting the development of globally relevant standards. Annex 3 of the WTO Technical Barriers to Trade Agreement calls for standardizing bodies to, wherever appropriate, “specify standards based on product requirements in terms of performance rather than design or descriptive characteristics.” The procedures governing the work of ISO and the International Electrotechnical Commission (IEC), also stress the need for maximum freedom in technical development, placing emphasis on requirements that are expressed in terms of performance rather than design-based or prescriptive characteristics. (2) In practice, there may be cases where the development of a set of requirements that are completely design-based is not only appropriate, but also helps to ensure global relevance. There may be other cases where a standard that is largely performance-based may appropriately include design requirements for certain provisions. Which approach is most appropriate depends on the technical matter in question and which characteristics are suitable for worldwide, or “universal,” acceptance.

Principle 4
Given existing and legitimate market differences, an ISO standard may pass through an evolutionary process, with the ultimate objective being to publish, at a later point, an international standard that presents one unique international solution in all of its provisions.

An ISO technical committee or subcommittee will also consider how best to address the current and potentially changeable differences in markets that impact the ISO deliverables they produce. Such changeable factors range from legislative requirements to social conditions, including trade patterns and market needs, scientific theories, design philosophies, and more.

In some cases, an ISO committee may choose to develop performance requirements that can then be supported by more detailed regional or national standards. Though there are few applications of such approaches, one recently published example is ISO 19938: 2003, Performance and Assessment Requirements for Design Standards on Structural Concrete, which lists regional consensus standards that are “deemed to satisfy” the requirements of the international standard.

When market differences call for options to specific provisions, the alternatives may be presented in parallel clauses in the main body text, in normative annexes or in sub-parts of the standard. Whichever form the options take, the committee will ensure that all options are treated equally. ISO Technical Committee 153 Subcommittee 1 has chosen to develop ISO 7121, Metal Ball Valves for General Purpose Industrial Applications, using parallel clauses in the main body text. ISO/TC 23/SC 3 is developing ISO 4254-1, Agricultural Equipment – Safety – Part 1: General Requirements, using normative annexes. In all cases, the intent is to keep to a minimum the number of optional requirements within the standard.

Principle 5
Essential differences consistent with Annex 3 to the WTO Agreement on Technical Barriers to Trade can be included in international standards.

Embedded technological infrastructures and climatic, geographical or anthropological differences are factors that will rarely change over time. Because certain committees may need to consider how these essential differences impact the standards they are developing, specific rules have been detailed in the ISO implementation guidance document.

Principle 6
Committees can only ensure the global relevance of the international standards they produce if they are aware of all the factors that may affect a particular standard’s global relevance.

The participation of all relevant ISO member bodies is seen as a major factor in supporting global relevance. Developing countries frequently have difficulty acquiring the capability, expertise and resources to participate directly, but experts from more developed markets may also be precluded from participation. Whatever the reason, it should be expected that the participating committee members – whether leaders, delegates or contributing experts – should be aware of the specific needs of non-participating, but materially affected parties. Because manufacturers and service providers are very aware of the needs in all markets where they conduct their business, the representatives of these organizations are seen as having a particular responsibility, and perhaps even an ethical duty, to bring this market knowledge into the standards development process.

Making a Difference

Recently, a larger number of European voting members than non-Europeans comprised the membership of the ISO committee on boilers and pressure vessels (ISO/TC 11) and the committee on welding (ISO/TC 44). This imbalance during the standard development process was leading to content that reflected the European regulatory regime to the exclusion of approaches that would be responsive to markets in other nations and regions. At the American National standards Institute’s request, the ISO Technical Management Board decided to apply the new ISO global relevance principles, effectively halting the progress of work projects in both committees until work plans could be developed that would realize globally relevant documents.

The real value of ISO’s new global relevance policy is that it calls for each committee to consider more carefully the value of the standards that it provides and to consider that value from the perspective of all concerned parties, not just from the view of the committee’s voting members. The market profiles and needs analysis results must then be incorporated into the business plans that have been developed and maintained for each ISO committee. These plans serve as important reference points as the committees work to develop requirements that acknowledge, address and evolve with ever-changing market and essential differences.

“One standard, one test, accepted worldwide” is a laudable goal set by ISO, but it is only achievable if another element exists as a precursor: one global market. Evolving dynamics mean that a single global market does not yet exist in all cases. However, the ISO global relevance policy presents countless new opportunities to engage interested and affected parties in the development, promulgation and implementation of international standards that can accommodate market, societal and essential differences while moving toward a single international solution. //

References

1 Article 2.2.2, ISO Statutes and Rules of Procedure
2 ISO/IEC Directives, Part 2, Clause 4.2 (Performance approach)

 
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