U.S. Conformity Assessment System: Conformity Assessment Used in U.S.
Conformity assessment is the
methodology used to evaluate compliance with voluntary consensus standards or
In the U.S. system, the level of risk associated with non-compliance drives decisions on the rigor
and independence needed for conformity assessment.
The greater the perceived risk, the more oversight and independence the conformity assessment system would typically have.
It is recognized that over-design of conformity assessment requirements for a given product may increase costs and cause delay
to market, while under-design will result in too little confidence in the product’s compliance and may impede the acceptance
of the product in the market.1 The diagram below depicts
the spectrum of confidence in a product’s safety versus the level of regulation imposed.
Confidence / Regulation Spectrum
In the United States, several globally
relevant approaches to conformity assessment are used in order to increase user
confidence in products, processes, systems, or personnel. These approaches
Conformity assessment approaches can also include the following activities (as defined by ISO/IEC Guide 17000:2004):
- Supplier's Declaration of Conformity (SDoC):
Procedure by which a first party or supplier conveys assurance that the object of conformity fulfills specified requirements.
Determination of one or more characteristics of an object of conformity according to a specified technical procedure (test method). The action of carrying out one or more tests.
Examination of a product design, product, process, or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements.
Third party attestation related to products, processes, or persons that conveys assurance that specified requirements have been demonstrated.
Third party attestation related to a conformity assessment body conveying a formal demonstration of its competence to carry out specific conformity assessment tasks. (These tasks include sampling and testing, inspection, certification and registration.)
In summary, the following matrix provides an indication of which parties may carry out which functions:
When first parties perform testing, suitability for the market is determined by a third-party testing laboratory.
When first parties perform inspection, suitability for the market is determined by a third-party inspection body.
In fact, first parties may certify but this is defined as "Supplier's Declaration of Conformity" (1st column).
1st Party Conformity Assessment