Good things happen when standards are fulfilled. A flex-fuel car runs smoothly and efficiently when we fill the tank with E85 fuel that meets a standard. A toll booth transponder, which meets a standard, communicates and pays the tolls during a summer drive from Chicago to Maine and then down to North Carolina while protecting the security of the credit card it is linked to. A new microwave oven, which meets a standard, plugs in to an electrical outlet and works exactly as the instruction book states with the needed protections for safety. Of course, it takes some time to learn all the functions and buttons, but it does work!
When standards are not fulfilled, we don’t get the expected good outcomes. Sometimes that is a relatively minor annoyance that we can easily observe and fix. In other cases, serious or severe damage to life, health, the environment, or property results that we don’t know about until it is too late to avoid (a damaged car, traffic violations, or a kitchen fire).
It seems there should be some effort made to give assurance that standards are fulfilled. Not just for consumers, but also for all the companies and organizations who would suffer unwanted outcomes when standards are not fulfilled; like an E85 gas station, a toll bridge or toll road authority, and a home insurance company.
What Is Conformity Assessment?
Conformity assessment is the name for a broad range of activities to provide assurance that standards, or more generally, specified requirements, are fulfilled. According to ISO/IEC 17000, Conformity Assessment is defined as “demonstration that specified requirements are fulfilled.” The demonstration is usually on a sample since the conformity assessment process often destroys the samples that undergo the demonstration; for example, chemical analysis of E85 fuel, heat and sunlight resistance of a toll transponder or safety testing of a microwave oven. A successful demonstration, sometimes coupled with an obligation or commitment to provide the product or service that is the same as the sample, has met a very broad range of assurance needs for well over 100 years at a reasonable cost.
Who Does the Demonstration?
So, who performs the conformity assessment demonstrations? That depends on the situation and especially the consequences of not fulfilling a standard, like a damaged car, traffic violations, or a kitchen fire.
In cases where the consequences of noncompliance are of little or no significance a demonstration might be done by the manufacturer or service provider during production, delivery, or quality processes. These demonstrations might not even be known to the consumer, especially when a guarantee or warrantee is also offered to provide assurance.
In other cases, assurance is needed that the consequences of noncompliance are prevented by fulfilling a standard; it is not enough to correct a noncompliance when it arises. These demonstrations might be done by an independent organization. Such organizations stake their business survival on providing competent, impartial, and consistent demonstrations that standards are fulfilled. Some even impose an obligation for ongoing fulfilment as a condition of performing a demonstration.
In still other cases the consequences of noncompliance are so high that the user of the product or service performs the demonstrations themselves. Consumers rarely have the knowledge or capability for this. However, government and industry users of products and services do and can performs demonstrations for their own assurance needs.
What Is a Conformity Assessment Body?
Any person or organization that performs any activity that is part of a demonstration that standards, or specified requirements, are fulfilled is a “conformity assessment body.” In the broadest sense anyone is a conformity assessment body if they have performed an activity that demonstrates a requirement is fulfilled. More commonly, however, “conformity assessment body” means a person or organization with the knowledge and capability that performs activities in formal or structured demonstrations; examples include the manufacturer or provider of the product or service, an independent organization in the business of providing assurance by demonstrating fulfillment of requirements, or the user of a product or service and those who protect user interests.
Common examples of activities in a demonstration include selection and preparation of samples; testing in a laboratory or in an actual use setting; inspection; auditing; information analysis; review of these activities and results obtained; decision that a suitable, adequate, and effective demonstration has been completed; and issuance of a letter, report, certificate, or other statement indicating a successful demonstration was completed.
In any given demonstration, multiple conformity assessment bodies can be involved. The choice of which bodies perform which activities is driven by the balance between the related costs and the assurance that is needed as described above.
Types of Conformity Assessment Bodies
Conformity assessment bodies (CABs) come in a variety of organizational forms and ownership; they can be commercial in focus or non-profit entities. Here are some examples of the different types of CABs that can undertake conformity assessment activities:
- Governmental agencies
- National standards bodies
- Trade associations
- Consumer organizations
- Privately owned companies
- Publicly owned companies
CABs range from multinational companies to those offering national products and services within one specific country, or small localized entities that work in a specific sector or region.
Conformity Assessment Bodies and You
In your work life and personal life, you are likely using the results of conformity assessment bodies without realizing it. Just as standards play an increasing role in daily life, conformity assessment bodies are hard at work delivering needed assurances largely in the background. Standards and conformity assessment are an assurance safety net for improving quality of life for now and the future.