Introduction to Conformity Assessment and Compliance

| Don Heirman

In this issue, we look at two different aspects of product compliance. With videos, we show the role of conformity assessment in ensuring that products meet design standards and regulatory compliance. We also provide insight into what is involved in actual testing to demonstrate compliance to design standards and meet regulatory requirements in both North America and the European Union (EU) as two major regions of the world. We discuss in this article not only the role of testing but also acceptance of products based on the manufacturer indicating that the product was designed for its purpose of use and is safe. We have invited several contributors to cover conformity assessment and regulatory compliance as well as the testing needed to show compliance. You will find articles on these subjects from the following authors:

  • Bill Hurst, US Federal Communications Commission (FCC)—comments by a regulator on meeting regulations that apply to all products operating with microprocessors, including those that communicate via wireless media; see requirements for digital devices in this section
  • Ray Klouda, Elite Electronic Engineering—the role of a testing laboratory to show compliance with regulations
  • Ben Gorini, Nokia—a look at international approaches to providing standards to meet regional regulations; see this link for the EU Standardization Organizations
  • Todor Cooklev, Purdue University—an example of standards application for wireless products that meet standards and regulations;
  • Antonio Farone, Motorola Solutions—an explanation of why wireless products need to meet human RF exposure requirements and what this entails
  • H. Stephen Berger, TEM Consulting—a view of consumer reaction to the need for products to truly meet regulations and in fact work as advertised; see this link for the Hearing Industry Association noting news articles the US Food and Drug Administration (FDA) clearing the way for at-home hearing tests.
  • Ghery Pettit, Pettit EMC Consulting—an overview of key U.S. and international standards development organizations along with examples of significant standards they have developed; see this link for the IEC organization that developed emission standards.
  • Andrew Myles, Cisco—a discussion of the trade-off between innovation and regulation in unlicensed spectrum.

We also offer a three-part series of videos:

Virtually all products either have a microprocessor control (which emits incidental or unintended signals) or transmit wirelessly, if not both. Hence every manufacturer is concerned with this aspect of regulation compliance, as are the end users/customers. The manufacturer is also concerned that its products meet a need functionally. There are also requirements for all electronic products to meet a variety of regulations including safety [both from electrical shock and human exposure to radio frequency (RF) energy], interoperability with other devices/systems, RF emissions to control interference with other electronic products, and, in some countries, immunity to the RF environment at the typical location where the product is used. How then are these aspects assessed to be true? Both conformity assessment and regulatory compliance testing play a role here.

Government agencies around the world regulate products to ensure they do not interfere with radio services and actually work in the environment in which they are used. Our regulatory story was provided by the U.S. FCC and by a standards manager highly active in European Committee for Electrotechnical Standardization (CENELEC) which supports compliance requirements and the standards needed to show such compliance.

The European Union is a major player in interference control as is the FCC. Interference is generated from products that have unwanted and operational signals that could disturb other products. The Voluntary Control Council for Interference (VCCI) of Japan is another body that has recognition much like a regulatory authority and as such establishes requirements to control interference. They reference primarily standards produced by the International Electrotechnical Commission (IEC) on how to measure emissions as well as the limits to be met.

In North America, the limits are set only by regulatory bodies and are not included in US measurement standards. While conformity to IEC standards and most others is voluntary, observance of these standards becomes mandatory when regulators reference them in their “rules” to show product compliance. Thus, emission limits are established globally as there is a worldwide need to protect radio services from the interference generated by electronic devices.

Immunity (the ability to withstand interference from other sources that emit radio signals), however, is not regulated internationally. In the United States, for example, immunity is addressed by the Food and Drug Administration (FDA) for medical devices. The FCC however does not address immunity for digital devices (sometimes called unintentional radiators), as they rely on manufacturers themselves to determine what immunity levels should be used to reduce customer complaints and show the quality of their products. In the European Union, immunity is addressed for most commercial products as this requirement is called out in an EU Directive. Hence there may be different test levels required worldwide that must be taken into account in performing immunity compliance testing.

In addition, safety is also regulated worldwide, as it is in the United States by the Occupational Safety and Health Administration (OSHA). For safety with RF fields, human exposure must be measured for all products that transmit signals, such as mobile and smart phones (the IEEE 802 series of standards generally covers wireless transmitter design requirements). The compliance test is quite complex to show adherence to FCC and other similar limits, such as those of the International Commission on Non-Ionizing Radiation Protection (ICNIRP), are strictly enforced in most parts of the world.

Major manufacturers also have internal compliance testing capability. For instance, CISCO Systems and Apple have well established testing capabilities. Third-party testing is available in the marketplace to cover manufacturers that do not have such compliance testing capability or that simply want to have an independent check on the internal lab results. Fortunately, there are many third-party electromagnetic compatibility (EMC) testing organizations. EMC covers both emission and immunity testing. In the United States, the American Council of Independent Laboratories (ACIL), a major trade organization of EMC testing labs, is a good contact for manufacturers seeking such third-party testing as they can put them in contact with competent test laboratories.

Another important aspect is ensuring that compliance measurements are conducted at a high level of competency by the testing laboratories. Most third-party testing organizations and some manufacturers’ labs are assessed by accrediting bodies. These accreditation bodies assess the quality of both testing facilities and the competency of the test engineers performing compliance tests. In the United States, there are two major accrediting bodies which are recognized internationally as well. They are the National Voluntary Laboratory Accreditation Program (NVLAP) operated by the U.S. National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, and the American Association for Laboratory Accreditation (A2LA) operating out of Frederick, Maryland.

Many accrediting bodies worldwide are members of the International Laboratory Accreditation Cooperation (ILAC), and both NVLAP and A2LA are ILAC members. ILAC membership is important for international recognition as ILAC members assess and accredit conformity assessment bodies (to relevant international standards) among those that sign a mutual recognition agreement.

These assessments are generally conducted every two years but can be more frequent if any significant deficiency is found needing immediate attention. We also need an organization that speaks to user confidence. In the realm of hearing aids, there is the Hearing Industry Association (HIA), which advocates at times for their user community. We welcome feedback from this or any other consumer group on their view that products they use meet regulatory compliance. One of the articles in this issue provides more details about such customer expectations based on the author’s experience with HIA.

There is always the need for feedback from regulatory authorities and perhaps the end users of products that presumably meet compliance requirements. Most customers see labels on products and assume that placing them on the product is tantamount to “automatic” compliance with regulatory needs. However, if you examine the exterior of an ac/dc converter that powers your laptop computer, you will see a myriad of labels from all over the world that presumably show compliance with the requirements of the countries whose labels are shown. But is this true in all cases? Manufacturers bear responsibility for verifying the truth of this, a task they take seriously. It would be good to hear the views of product regulators in many countries that products are truly complying with regulations. This is a sensitive subject as the premise is that all comply; however, we know from field complaints that some do not, thus disrupting the operation of adjacent equipment (now usually called a “disturbance”) and radio services, or even affecting the user’s electronic products. The FDA and FCC have a complaint mechanism in place for reporting such problems. But the time and budget of these organizations to sample compliance with products in the marketplace are extremely limited. Reported problems have been published in trade magazines, and such incidents can be searched for and even cited.

In summary, enjoy the breath of videos and articles included in this edition of the e-zine on the use of a conformity assessment scheme, showing compliance with regulations, and the integral part that standards play in compliance assessment, particularly in performing compliance and conformity measurements.

Donald Heirman is president of Don HEIRMAN Consultants, LLC, which is a training, standards, and educational electromagnetic compatibility (EMC) consultation corporation. Previously he was with Bell Laboratories for over 30 years in many EMC roles, including Manager of Lucent Technologies (Bell Labs) Global Product Compliance Laboratory, which he founded, and where he was in charge of the corporation’s major EMC and regulatory test facility and its participation in ANSI accredited standards and international EMC standardization committees. He chairs or is a principal technical contributor to U.S. and international EMC standards organizations, including ANSI ASC C63® (immediate past chairman and chairman of the C63.4 working group), the Institute of Electrical and Electronics Engineers, and the International Electrotechnical Commission’s (IEC) International Special Committee on Radio Interference (CISPR). He was CISPR chairman between 2007 and 2016. He has been the chairman of the IEC’s Advisory Committee on EMC (ACEC) since July 2013. He is also a member of the Technical Management Committee of the U.S. National Committee of the IEC. In November 2008, he was presented with the prestigious IEC Lord Kelvin award at the IEC General Meeting in Sao Paulo, Brazil. This is the highest award in the IEC and recognizes his many contributions to global electrotechnical standardization in the field of EMC. He is a life fellow of the IEEE and an honored life member of the IEEE EMC Society, past member of its Board of Directors, chair of its technical committees on EMC measurements and Smart Grid, former Vice President for Standards, past EMCS president, and past chair of its standards development committee. He is also the former president of the IEEE Standards Association (SA) and past member of the SA Board of Governors and the IEEE’s Board of Directors and Executive Committee. He was the Associate Director for Wireless EMC at the University of Oklahoma Center for the Study of Wireless EMC. He now teaches the practical application of EMC compliance measurements at Purdue University, West Lafayette, Indiana, USA. He has also a special collection of his career EMC-related papers in the Purdue Library Archives. This was established for researchers in the area of EMC standardization. Access is available online (see URL home page). He is a voting member of the U.S. Smart Grid Interoperability Panel (SGIP) (now called the Smart Electric Power Alliance) and its Testing and Certification Committee. In addition, he is chairman of the SGIP Electromagnetic Interoperability Issues Working Group, which is providing EMC recommendations for Smart Grid equipment and systems. He also serves as the consultant on Smart Grid matters for the Conformity Assessment section of the American Council of Independent Laboratories.