Standards Developer’s Drive for International Harmonization

The drive for standards harmonization is but one element, albeit an essential element, of the overall trend for manufacturers to seek global market access for their products. Standards developers, testing organizations and government bodies all need to adjust their policies and practices to respond to the global market. This article explores current initiatives in standards harmonization and the resultant initiatives in product certification.

The standards development process must facilitate, rather than impede, trade while reflecting time-to-market sensitivities of technology-driven sectors and producing standards that are globally relevant and technically sound. The process and principles used to develop standards must meet the World Trade Organization Technical Barriers to Trade (WTO-TBT) definition of an “international standard”, “…to ensure transparency, openness, impartiality and consensus, effectiveness and relevance, coherence…”

The Spectrum of Harmonization

The process of standards development and product certification are intertwined. The term “harmonization” refers to a process by which the technical requirements of various standards have been made equivalent or identical. Although the actual words comprising harmonized standards may be different, the performance requirements or safety issues have been addressed equally. By using a harmonized standard, manufacturers and certification agencies can be assured that any product tested to one standard will meet the requirements of another standard.

We can define the levels of harmonization as:

Further harmonization may occur through technical equivalency. Many times, requirements are different, that is, different methods used to conduct a test to evaluate the same property, but they both may establish a “level of safety” that is acceptability equivalent. Requirements that are technically equivalent are also technically compatible. For example, one standard may require an appliance to be subjected to a drop test and a corresponding standard may require an appliance to be subjected to an impact test. In each of these tests, the appliance is subject to impact. Different methods are used, but the end result of the tests could be considered technically equivalent in that the product has been tested for the property of impact resistance.

A Model for Harmonization

The affected industries must encourage and support harmonization. As such, the particular industry is heavily involved in identifying the need for harmonization, including the level of harmonization desired. For example, while a standards developer, such as UL, may support international harmonization with IEC or ISO standards, some industries are not ready for that level of harmonization. They may desire a more Regional approach towards harmonization, such as through harmonizing requirements within North America. A national standards body or standards developer must take a very active and committed role with harmonization; however, they can’t do it alone. Therefore, with each new harmonization effort, representatives from the industry must be identified who will participate in the harmonization effort. Once the players have been identified, they will need to determine the phases and schedule for harmonization.

To comply with the intent or actual terms of the WTO-TBT Agreement, accredited national standards bodies must adopt policies that have a strong international thrust.

First, participation in ISO and IEC standards activities to develop new internationally accepted standards is essential. This is particularly relevant when no national, regional, or international standard exists. Such participation may also include increased participation in the applicable national standards systems.

Second, when a need for a new standard has been identified, primary consideration should be given to adopting an existing international standard if the requirements fully address the level of safety expected by the public.

Alternatively, if the International Standard is not fully sufficient, it may form the basis for a new standard, modified to include National Differences to address the level of safety expected by the national safety systems.

Third, when no ISO or IEC standard exists, yet a national standard exists, the accredited national standards body should promote the adoption of the existing national standard as an international standard without differences if the requirements of the national standard addresses the levels of safety expected by the various national safety systems.

Lastly, for those situations where both a national standard and an IEC or ISO standard exists, and where the scopes of the standards are generally aligned, the preference is to harmonize the national standard with the ISO or IEC Standard (or the ISO or IEC standard with the UL Standard) with as few national differences as possible.

Standards Adopted with Differences

Industry and user needs are the key to harmonization with international standards. Harmonization with international standards may well require the involved industries to modify specific products. Modifications may require considerable investment of time and money. It becomes difficult for manufacturers to make changes that are costly, and add little or nothing to the safety of the products involved, simply for the sake of harmonization. And, yet, as the motivation to seek global markets grows, conformity to international standards becomes a prerequisite. Typically when a country adopts an international standard, the standard is adopted with differences. These differences may be labeled either as “national conditions” or “national differences”.

Justification for identified National Differences may include:

National differences can and should be minimized by:

National Safety Systems

The national safety system in place in any country is a product of its culture. Most safety systems are a unique mix of voluntary and mandatory components, with roles for a variety of interested parties. Three elements that generally work together in any country are: product standards, installation codes and regulations. While these elements are separate, they have two things in common: they identify the requirements to be met and they contain mechanisms to demonstrate compliance to those requirements. Product standards contain requirements for the safety and performance of products. Generally, standards are developed by a variety of groups. Codes address the safe installation, application and placement of products and materials. Significantly, these codes are generally adopted word-for-word or with minor modifications by local governments as law. The third element, regulations, mandates safety requirements covering employers, employees and consumers.

Third Party Certification — The Bridge of Confidence

For the manufacturer, the end means of harmonization is to minimize the cost of product testing while gaining acceptance of their product in multiple markets. Product certification plays an integral role in that process. One such means of product certification is third party. There are a number of reasons why a manufacturer may decide to pursue third party certification. In general, the chief reason is that market forces require evidence that products comply with standards, codes and laws.

As in any transaction, the seller wants to sell a product to a buyer. A buyer will only purchase the product if they have confidence that the product will fulfill a need. Along with usability, quality, service, etc., buyers need confidence that the product complies with standards, codes and laws. Third party certification can provide the bridge of confidence that a product complies with standards, codes and laws.

Bilateral Reciprocal Arrangements

A related imperative to standard harmonization must be treated — namely, some form of reciprocity of test data or certification among product approval systems in various countries. In this case, the process becomes even more complicated than harmonizing standards.

When a product is marketed in various countries, it has the need that the requirements to comply with are the same (need of harmonization of standards) and then has the need not to repeat unnecessary tests in the various countries. As a consequence, these issues have given rise to various agreements among certification organizations within economically homogeneous areas. The IECEE/CB Scheme mutual recognition of test results is growing. The great development of the CB Scheme demonstrates the effectiveness of this mechanism as a response to the real trade issues of manufacturers. Previously, when manufacturers made use of mutual recognition agreements on test results or the CB Scheme, the final certification granted was always one or more marks of conformity owned by each certification organization involved. With these agreements, certification is represented by one mark of conformity having a regional or wider recognition. The same mark may be granted by any one of the organizations participating to the relevant agreement. Examples of this are some European marks. A foreseeable next step could be an international mark having a worldwide acceptance.

Four main conditions must exist for implementation of an international mark of conformity:

Furthermore, all certification organizations participating in the scheme must have a well-established certification scheme in their own country and must be committed to recognizing the common mark as equivalent to their own mark. A consequence of this trend from nationally recognized marks to an international mark means better service for industry, but also a further reduction of business for certification organizations, since not only type test and initial assessment will be conducted by a single organization as well as certification and follow-up inspections. The advantage for industries is that they deal with a single certification organization for certification recognized in several countries.

The above content is extracted from a presentation delivered by Robert A. Williams, Vice President, Standards Department of Underwriters Laboratories, at the World Congress on Safety and Health at Work, Seoul, Korea 2008.