Standards are essential tools for implementing conformity assessment systems. A conformity assessment system seeks to evaluate compliance of a product or service with requirements. Customers buying products have expectations which in their minds and, not infrequently, in reality are also requirements. Customers may not be aware of it, but they depend on standards and the conformity assessment processes that use them to provide them with products that meet their needs. It is probably hard to think of a product that does not have customer expectations, which can be viewed as customer requirements. A hearing aid is a good example, but only one of many that we could discuss. Hearing aid wearers expect that a hearing aid will help compensate for their hearing loss. One particular situation in which hearing aid wearers want the device to work is when making a phone call. Customers expect their hearing aid to work no matter whether it is a wireline call, a cellular call, a cordless call, a VoIP call, or any other kind of phone call. Customers don’t what to have to deal with the underlying technology. They just want to make a phone call and be able to understand the person they are talking to. In this case, there is a TIA standard covering wireline and cordless phones and an ANSI standard covering cellular and VoIP. These standards translate the hearing aid users’ expectation into technical requirements that the Federal Communication Commission (FCC) requires phone manufacturers to meet.
One challenge is that customer expectations are thought of in the way we commonly speak, but to be evaluated, requirements must be technically precise. A translation must be made from plain language into technical specifications. What does it mean to be able to “use the phone” or “hear the other person?” These needs are easily understandable but are not evaluable. How many dB SPL of audio volume equates to “hear the other person?” At what point is the volume so low that it can be determined the user cannot “hear the other person”? Is volume the only requirement? How about distortion, noise, and fidelity? Is the real technical requirement a single parameter or multiple parameters? Standards translate plain language requirements into technically precise, evaluable specifications.
As we go deeper into the conformity assessment process, we can say that what a laboratory assessor needs to explore is the ability of a laboratory to do a test correctly. Once evaluators see that a laboratory has the equipment, processes, and appropriately skilled staff to do a test correctly, they turn their attention to the laboratory’s management and quality systems. Having seen that a laboratory can do a test correctly, they then look for evidence that the laboratory can be expected to do the test correctly every time. This process of laboratory assessment relies on standards, foundationally ISO 17025, the laboratory evaluation standard, to convert these requirements into specific, evaluable specifications.
Customers have little interest in the details of how laboratories or lab assessors do their work. What they care about is the end result. If a person uses a hearing aid, he or she wants to be able to use the phone, every time, no matter what kind of phone it is. All of us want to be able to fill a prescription and have confidence that the medicine we take is what the doctor ordered. When we go to a restaurant, we do not want to wonder if the food we are eating is safe. All these user needs rely on standards to convert easily understood expectations into technically precise and evaluable requirements that laboratories can follow and lab assessors can confirm are being routinely followed. In this way, we can rely on products and services to meet the requirements we have and count on them to provide.
Mr. Berger is president of TEM Consulting, an engineering services and consulting firm in Georgetown, TX. He provides leadership in areas of unlicensed spectrum, standards, regulatory approvals and public policy, data collection, analysis, and interference mitigation techniques. Among his current standards projects, he is co-chair of both:
- The ANSI C63.27 working group developing standard test methods for wireless coexistence.
- The AAMI TIR-69 working group developing guidance on evaluating the risk associated with the use of wireless in a medical device or healthcare delivery system.