The standardization process is, in effect, a group problem-solving exercise. US voluntary consensus standards are developed to create solutions to problems that have the added benefit of reflecting the consensus of interested parties. Because they are based on consensus, standards are far more likely to be adopted as solutions. But a standard has to be fulfilled for the solution to be effected. And that is where “conformity assessment” comes in as an activity related to voluntary consensus standards.
In some cases, advertising or a guarantee will convey a promise a standard is fulfilled. In others a contract or regulation will create an obligation to fulfill a standard and impose penalties when nonfulfillment is discovered. While both approaches are commonly used, they might not meet the higher need for assurance that nonfulfillment, and the associated negative consequences won’t happen in the first place. Conformity assessment is intended to meet demands when this higher need for assurance arises.
WHAT Is Conformity Assessment?
Conformity assessment is one or more activities that demonstrate standards (or more generally, specified requirements) are fulfilled. Activities used in conformity assessment include sampling, testing, inspection, auditing, examination, validation, verification, supplier’s declaration, and certification.
WHY Does Conformity Assessment Provide Higher Assurance?
Once a demonstration is completed and used to assure others, it provides a significant benefit and becomes a valued asset. But that asset only continues to deliver benefits if the standard continues to be fulfilled. So, a successful demonstration shows fulfillment is achieved at one point in time but also creates an incentive to achieve ongoing fulfillment.
WHO Performs the Activities?
People or organizations who perform activities in a demonstration are collectively referred to as “conformity assessment bodies.” Several different bodies might perform activities in a single demonstration. Activities performed by the person or organization that provides the object that fulfills the standard are “first-party activities;” activities performed by a person or organization with a user interest in the object are “second-party activities;” and activities performed by a person or organization that does not provide the object and has no user interest in the object are “third-party activities.”
HOW, WHERE, and WHEN Are Demonstrations Performed?
The set of rules and procedures that govern the details of a demonstration is called the conformity assessment scheme or program. Because at least some of these details are decided before a demonstration begins a scheme or program always exists for a given demonstration. The methods of deciding and documenting these rules and procedures are as varied as conformity assessment activities themselves. For example, a scheme or program might be captured in a contract or created through a negotiation. A scheme or program can be created via a standards development process and documented in a voluntary consensus standard.
Costs are incurred when performing conformity assessment. The greater the number and extent of activities the higher the costs. Decisions about the details of a demonstration (the scheme or program) result from balancing the costs of the activities and the extent of needed assurance. The more severe, likely, or pervasive the consequences of nonfulfillment, the greater the need for assurance and thus the higher the costs that can be justified. Such balancing is an ongoing activity since change can alter the balance. As a result, the scheme or program for conformity assessment must be exposed to, not separated from, changing conditions and adjusted accordingly so the optimal balance can be maintained.
Private sector conformity assessment schemes or programs can respond to change by including all interested parties in decisions about the rules and procedures, a clear parallel with voluntary consensus standards. Government conformity assessment schemes or programs can respond to change using public comment processes or other mechanisms through which interested parties can provide input.
Just as with standards development, conformity assessment can be a public-private partnership especially when the requirements come from government regulations. The most common model is for the government entity to create the scheme or program for conformity assessment which specifies the ways in which private sector conformity assessment bodies can carry out the conformity assessment activities, including any required interactions with the government regulator.
The Role of Accreditation in Conformity Assessment
In all its manifestations, conformity assessment only provides assurance when the bodies carrying out the activities are competent, impartial, and consistent. This is where accreditation comes in. In standards development, ANSI accreditation demonstrates that standards developers establish and follow procedures that fulfill ANSI essential requirements. Accreditation means something different in conformity assessment.
In conformity assessment, accreditation results from a demonstration that a conformity assessment body fulfills standards for competence, impartiality, and consistency. Both international standards (ISO/IEC 170xx standards) and national standards provide requirements depending on the kind of activity the body performs. Accreditation is the result of a very specific type of demonstration: one involving a conformity assessment body as the object and a standard for competence, impartiality, and consistency. ANAB (ANSI National Accreditation Board), as a wholly owned subsidiary of ANSI, provides accreditations for all types of conformity assessment bodies and provides conformity assessment expertise to those developing and maintaining schemes or programs.
ANAB also actively participates in over 160 individual standards development engagements and offers self-paced training that provides the basic principles common to all conformity assessment worldwide that will quickly boost attendees’ conformity assessment IQ. And of course, ANAB has experts to assist in understanding existing conformity assessment and developing new conformity assessment wherever it is needed. Submit your request to anab@anab.org to start a conversation.