The IEC coordinates a worldwide system for testing electrical equipment.
International Electrotechnical Commission
Geneva, Switzerland
How does a hospital manager know that equipment such as a CAT scanner, when operating, will not affect nearby electromagnetic systems in the building, such as an X-ray machine, thereby potentially putting patients at risk?
Since the early 1960s, when electrical apparatus became more widespread, not only in specialist areas, but also in the home and work place, the International Electrotechnical Commission (IEC) began to address the issue of electromagnetic compatibility. Hospital equipment is just one of the areas of electromagnetic compatibility that the IEC addresses in preparing its global standards. The part played by electricity in our lives, and therefore that of EMC, is not likely to lessen.
100 YEARS OF SERVICE TO THE MARKET
Founded in June of 1906 in London, the IEC is currently in its centenary year. During its hundred years of existence, it has established norms such as the Hertz, the electromagnetical unit used for measuring frequency of all types of periodical events, laid down standards for a variety of electric current applications and created the multilingual International Electrotechnical Vocabulary (IEV). Today, it has more than 100 Technical Committees (TC) that continue to prepare safety standards, such as those related to the use and safety of emerging technologies like lasers and nanotechnology, or the electromagnetic compatibility of computed tomography and other such sophisticated equipment.
STANDARDS AND CONFORMITY ASSESSMENT SCHEMES
The IEC is a not-for-profit organization that operates on two levels. It exists firstly to create the standards that ensure the integrity and safety of a multitude of electrically related products, both those ‘banal’ ones we use in our everyday lives and those more specialist ones to which we occasionally entrust our lives. Its second area of operation is that of making certain that products, which are manufactured to those standards, are tested and certified in a uniform manner.
The IEC consists principally of engineers, specialists working in industry throughout the world, whose job it is to ensure that their products and those of their competitors are built and used in a safe and consistent manner. The IEC exists to ensure that the consumer, in other words you and me, can purchase, employ and be exposed to all types of electromagnetic products that have been manufactured, wherever this might be, according to a globally approved standard.
Producing an IEC standard is not a light process. The approval and refinement cycle may last several years. Essentially, to develop a standard once a new idea has emerged and preliminary discussions have taken place, it requires experts from a minimum of five different countries in order to start a new project. The TC will then produce a draft and the project leader follow up on suggestions submitted by the other experts, passing through various additional draft, correction and approval phases until a consensus is reached. At each stage of the procedure, the standard is sent out to a number of countries. In the case of IEC Technical Committee 77, which prepares EMC standards, there are 48 countries that take part in its discussions, either actively or as observer nations.
For a project to reach its final voting stage, the entire cycle must take less than five years. The standard is then submitted to all participating members and only issued provided they have given it a consensus vote.
How then does a radiologist in Singapore know that the Australian X-ray machine he operates on the third floor does actually correspond to an IEC standard and is not going to interfere with the ultrasound system next door? The answer lies with the IEC’s multilateral conformity assessment and certification schemes.
IECEE – ELECTRICAL EQUIPMENT
The notion of certification is synonymous with a product being assessed against IEC standards by a test laboratory and found to be compliant with the relevant safety requirements. Outside the IECEE however, testing laboratories and certification bodies are likely to use varying test methods, more or less thoroughly and according to varying criteria. Each test takes time, costs money and results in a different label or mark being granted by the relevant certification body (CB). Traditionally, manufacturers producing electrotechnical equipment and components in one country and wanting to export to another, had to undergo individual conformity tests and certification in each of the countries in which they wanted to market their products and provide, when requested to by the national authority, the necessary proof of compliance.
To counter this and reduce the barriers that prevent easy trade, the IECEE has put into place and operates a system of mutual recognition whereby there is reciprocal acceptance of test results carried out by any of its national members. The acronym IECEE stands for the International Electrotechnical Commission system for conformity testing and certification of Electrotechnical Equipment and components. IECEE members use a common approach in applying IEC standards, defining, by way of the committee of testing laboratories (CTL), common procedure and test methods that offer definite advantages to a manufacturer.
Take the example of NEMKO (Norges Elektriske Materiellkontroll), the Norwegian certification body. All its laboratories, whatever the country in which they are based, carry out national certification for a variety of electrical and electronic products. The testing laboratories are, however, also part of the IECEE CB scheme and operate under the direct responsibility of the NEMKO certification body. That implies that any product they assess and certify as being worthy of IECEE certification is not only certain to have been manufactured to high quality IEC standards, wherever it happens to originate from, but, in addition is eligible for immediate import into any of the other countries which are members of the IECEE scheme.
Indeed, once certification has been provided by any individual IECEE National Certification Body (NCB), there is no need for further testing or duplication of work since they all mutually recognize the validity of the CB test certificate and test report of the other. Examples of this might be Electrosuisse, the Swiss certification body, or PSB Corporation, the Singapore organisation, SABS, the South African NCB, or IRAM in Argentina. All are members of the IECEE scheme and recognise the CB test certificate of the other. The entire list of members can be found on the webpage http://www.iecee.org/cbscheme/html/cbcntris.htm.
In addition to the CB test certificate being mutually recognised by the IECEE members, in certain countries it is also considered valid by national authorities, regulators, retailers, purchasers and vendors and therefore grants immediate access to the relevant market place. The impact is one of an economy of scale with definite financial advantages. Eliminating the significant delays and costs that are incurred by multiple testing and approval cycles allows industry to bring a product to market faster and cheaper in a global context while still providing the general public and governments with the reassurance that products operate as expected and are safe to use.
MULTILATERAL CONFORMITY ASSESSMENT – CA
So, how does the IECEE system actually work? How can industrial users and final consumers in a particular country know with certainty that a product is guaranteed to be up to standard and therefore safe to use, both for them personally and in terms of their environment? How can they be sure that the product they buy actually conforms to the criteria of an IEC standard ?
The word multilateral provides the answer. The IECEE’s conformity assessment (CA) schemes are set up using IEC standards and intend to be truly global in concept and practice. As previously stated, the IECEE does not carry out the actual testing of products but is a global administrator, leaving the conformity assessment operation to its members, those specialist bodies in each country which could be national bodies, independent associations or testing laboratories.
The IECEE’s product certification schemes provide the reassurance and an internationally accepted means of proving that a product has been independently tested by the IECEE Certification Body Testing Laboratories (CBTL) and then produced according to the safety requirement as specified in the relevant IEC standards.
The schemes also help the user and the consumer. Technology is becoming steadily more present in every day life and more complex. At the same time end users are finding themselves increasingly aware that they depend on products of a multifarious design and construction that is not necessarily within their own scope of understanding. In this type of situation, it is a great comfort for a purchaser to know that a product has been tested and found to be compliant with the relevant safety requirements.
The quality levels of testing remain high since each test laboratory remains in competition with the other. If one laboratory fails in its assessment process they will be judged by the others. Since assessment is carried out among peers none can afford to be seen as the weakest link and influence the reputation of the ensemble. This notion of peer assessment forms an integral part of the CB scheme whereby testing laboratories are assessed regularly by an international team appointed by the IECEE secretariat.
Interview with Pierre de Ruvo, IECEE Executive Secretary
Q: How has the world of conformity assessment changed over the past 20 years?
A: There have been three big changes that are the result of globalization, all of them having to do with the need for faster market access, greater rigour and efficiency, and consistency among the NCBs and CBTLs. The markets have changed from being national or regional to being global. Conformity assessment is a tool that provides access to markets. Change therefore comes as a result of pressure from the industry to access markets more easily.
About 20 years ago manufacturers had to have a conformity assessment mark for each country that they wanted to access. In many cases conformity assessment fell under the regulatory area. But markets began to globalize and the old system came to be seen as inefficient. Europe with its regional schemes began using multilateral agreements and, in 1985, the CB Scheme came into being. By 1995, globalization was in full swing and the CB Scheme, which had not been as active as it could have been, started to gain in importance. Since globalization began, there’s been a move towards simplifying things by means of a single test and a single certificate for entry into multiple markets. Along with globalization came liberalization. Markets moved from mandatory to voluntary testing. This implies that it’s the participants in the market who decide whether or not to require certification. Since they’re free to do so, they recognize the value in choosing third-party certification.
Globalization and liberalization are still evolving and there are still different certification marks that are needed to access some markets, but CB Test Certificates play a great role in accessing these markets with their high acceptance and recognition by the relevant NCBs.
As for greater rigour, the IECEE focused on ensuring that peer assessment really was in-depth and professional and not just something cursory. The strength of the system relies on the competence of its members, so we have a fundamental interest in ensuring that each member measures up. We revisited our assessment procedure and made it much more intensive. At the same time we focused on the technical aspects and documented the entire process thoroughly.
Thirdly, when considering the operational aspects of IECEE systems we ensured that manufacturer testing laboratories were fully taken into account to ensure that we were consistent in applying IEC standards for product compliance. In turn, this means that we paid particular attention to the issue of product safety.
As markets globalized, manufacturers needed to access worldwide markets more efficiently and faster, so we developed new processes for them to do this: we supervised manufacturer testing, testing at manufacturer’s premises, witnessed manufacturer testing, and recognized manufacturer testing, the latter being the most demanding for manufacturers in terms of capability.
Q: Where is conformity assessment heading in the next several years?
A: Predicting the future is very difficult, but I think it’s clear to all that we will continue with two basic trends. The market is very competitive and the CB Scheme helps manufacturers to first reduce costs and, second, shorten the time it takes to get to market. I don’t see these trends stopping any time in the near future, so the CB Scheme will develop new procedures to remain responsive to industries’ evolving needs and at the same time we’ll develop new business opportunities with the CB Full Certification Scheme (CB-FCS) and the factory inspections/audits which are an important part of it.
Q: In 2000 the CB Scheme issued 19 600 test certificates. In 2005 that figure rose to over 40 000. Why is growth this strong?
A: More and more purchasers and retailers are asking for proof of CB Scheme testing and certification from their suppliers, just as some industrializing countries are insisting that imported goods be certified by CB Scheme testing labs. So manufacturers find themselves required to show proof of compliance against IEC standards. It ensures that electrical products are safe and performing and that’s good for both manufacturers and their clients.
The CB Scheme is the global reference for certification and good marketing by CB Scheme members has a great deal to do with its success. When clients ask about the best way to enter new markets, our members tell them about the CB Scheme. I suspect that some of our expansion also has to do with our members’ clients talking to each other, promoting us by word-of-mouth. So a little like that ubiquitous brown soda in the red-lettered bottle, the CB Scheme has become a trademark in its own right.
Q: From the international trade perspective, what is the added value for a manufacturer to seek certification under the IECEE scheme?
A: The CB Scheme provides an international passport that gives faster access to markets and the assurance that the products comply with the IEC standards. Multiple testing and multiple certification slows down access to multiple markets. Having a single test and one or more certification mark giving access to multiple markets is far more efficient. An in-depth peer assessment helps to ensure confidence-building among the members and confidence in accepting test results.
Q: Taking that point further, many developing nations have aired concerns that they are the potential dumping grounds for unsafe electrical equipment. Can the IECEE meet these concerns?
A: Let’s make it clear that the IECEE does not manufacture equipment, it coordinates and administers a worldwide system for testing electrical equipment.
For a country that has no electrotechnical industry and no recognized testing laboratory, the CB Scheme can still offer added value. These countries may wish to set rules for imported electrical products whereby only products that can show that they have been approved through the IECEE CB or FCS Schemes could be authorized to access their markets. South Africa is an example of a country that requires imported electrical goods to be accompanied by a CB test certificate. The CB Scheme can easily work with countries that have mandatory certification and assist in providing market access there.
Once industrialization starts and there is a nascent electrotechnical industry, then the CB Scheme has a great deal to offer since our test certificates will help to ensure the proof of compliance to IEC standards of both local goods for export as well as imported goods. An industrializing country with low labour costs and high-quality goods for export is in a very competitive position.
Q: How do you see the new IEC members benefiting from the IECEE? After all, if they are using IEC standards, should the next step not be the IECEE? What added value does IECEE membership bring to a country?
A: All the world’s industrialized countries are already participating members in the IEC, so new ones from now on will mostly be industrializing and developing countries – those whose electrotechnical industry is beginning to build up. To be a member of the IECEE, you need to be a member of the IEC although, having said that, it is possible to be a member of the IECEE and not yet of the IEC for an initial period of three years. The costs for doing this are higher than for IEC members.
But what’s really worth noting is the very reasonable entrance fees and subsequent annual fees to maintain membership. Once a country is a member, it has access to almost all services and documents, can participate in all meetings and can develop its expertise in testing and certification with its counterparts.
There are very clear benefits to this. Malaysia is a good example in case. It started as a Member Body and then later added an NCB and an associated CBTL. By participating as a Member Body of the IECEE and learning about it, by meeting all kinds of people from testing labs and from industry, the Malaysian delegates developed a very good understanding of how it all works. They took this back to Malaysia with them and influenced government and industry there, so that now Malaysia is active in issuing and recognizing CB test certificates and has aligned its standards with those of the IEC. This signifies a real transfer of technology and knowledge.
Q: How is conformity assessment carried out in different national contexts?
Essentially, the role of conformity assessment is to check to see if a product adheres to a standard. This falls into three categories:
- first party (the vendor), who provides the supplier’s declaration of conformity; in other words, the manufacturer carries out his own in-house testing;
- second party (the purchaser); in this case, the buyer does his own testing;
- third party, who is neither the vendor nor the purchaser but an independent testing service.
IECEE is third party but the schemes do not carry out testing themselves. Instead, they provide a valuable service to global trade by organizing independent testing laboratories into worldwide systems of mutual recognition of each other’s test certificates. This serves three different purposes. Governments want to protect consumers, so conformity assessment testing helps to ensure safety. Purchasers (usually wholesalers) want to ensure quality, so IEC CA helps to certify performance. As to interoperability, CA testing helps other manufacturers to know that their product will work correctly with the one being assessed.
Q: What are the advantages to manufacturers?
A: The great advantage to manufacturers offered by the IECEE is that it helps to reduce manufacturing costs by eliminating the cost of multiple testing. What’s more, a single test opens up new markets faster. And every manufacturer knows that being faster to market provides a competitive edge.
For importing countries, there are also clear advantages. IECEE testing helps to ensure the widest range of acceptable products for sale in a domestic market. Then there is the issue of favouritism. Because the IECEE is neutral, no one gets special treatment. All suppliers, whatever their origins, are treated equally within the IECEE. This means that their products must stand or fail on their own merits and not for some other reason.
What’s also worth noting is that importing countries are assured that the laboratory issuing a test certificate has what is called “adequate and enduring technical competence”. This comes from paragraph 6.1.1 of the World Trade Organization’s Agreement on Technical Barriers to Trade. Because the IEC has a close working relationship with the WTO, and because IEC standards and its CA Schemes help to serve as the basis for the TBT Agreement, all test labs in the IECEE must be of the right level of competence. Without this requirement, the quality of testing could be in doubt. Since the IEC’s reputation rests on its products and services, these must be – and are – of the highest quality. The means to ensuring this is peer assessment, where one laboratory in the IECEE performs an audit on another one that is either hoping to join or that is already a member. Peer assessment is seen as the single best way to achieve the highest level of confidence in the quality of service that a laboratory offers.
Finally, the IECEE provides importing countries with confidence in the compliance of the products they import. This means no dumping of poor-quality goods and no “hiding” behind false origins (e.g. a product built in one place but trans-shipped through another).
All in all, IEC International Standards and its CA schemes offer the global market products and services that help industry do business and reassure governments about the quality of imports and exports. But in the final count, the IEC’s focus is on the consumer. As the last link in the chain, the consumer is the key figure because, as end purchaser, the consumer remains the final arbiter when it comes to products and services. Those that pass the test of quality and that provide consumers with what they want remain in the market. Those that don’t will ultimately disappear.
Q: What are your hopes for the CB scheme?
A: I have had the privilege of working with testing and conformity assessment for 25 years now, and the development that has taken place over these years has been quite amazing; from small, local and often isolated markets to regional markets, and now increasingly towards a global market.
The CB Scheme is a successful example of the solutions that have been created to make global trade easier by using one test as the basis for market entry in several countries. Although most countries agree about the importance of joint standards as a way of creating trade without borders, we still have some way to go before this becomes reality.
We need to have a scheme with high credibility, that is flexible and market oriented. This might be easy to say, but the challenge is to use various elements in a consistent manner to retain trust among the acceptance interests, such as certification bodies, authorities, buyers and sellers, whether the testing is carried out in a third party laboratory assessed by the scheme or at the manufacturer’s premises through the certification body.
We have several important working groups that are evaluating expansion development of the scheme as well as simplification. We have the full certification scheme that also will include some factory inspection elements and we also have started promising activities with ILAC to cooperate in assessments that call on the competence and capabilities of both the CB scheme and the national accreditation scheme.
I am excited to be in a position that enables me to work on developing the CB Scheme further and to be able to promote important issues that will make life easier for manufacturers and retailers by speeding up the process of accessing the world’s markets.
The International Electrotechnical Commission (IEC) is the global organization responsible for developing and publishing international standards and specifications for all electrical, electronic and related technologies. The membership consists of more than 60 participating countries, including all the world’s major trading nations and a growing number of industrializing countries. Its standards are used in more than 100 countries as the basis for national rules and standards.
