U.S. Conformity Assessment System: Key Organizations
The U.S. conformity assessment system consists of public and private-sector players who work together to achieve shared objectives. A chart showing the interaction between the key players is provided below.
The key stakeholders in the U.S. system are listed below, along with a brief description of their roles and responsibilities. More information is available from NIST's Standards Coordination and Conformity Group.
AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI)
ANSI’s role in conformity assessment is two-fold. Consistent with its mission, ANSI has a designated role of promoting and facilitating the U.S. conformity assessment system. In this capacity, ANSI serves as a neutral policy forum to develop U.S. policies relating to conformity assessment. ANSI’s second role in the U.S. conformity assessment system is as an accreditation body (see below). In this second capacity, ANSI also is involved in several international and regional organizations to promote multilateral recognition of conformity assessments across borders to preclude redundant and costly barriers to trade.
ACCREDITATION BODIES
Accreditation bodies recognize the competence of conformity assessment bodies (testing labs, inspection bodies, certification bodies, etc.), ensuring that these bodies are legal entities, independent and free of conflicts of interest, employ qualified people, and have proper oversight. Accreditation programs generally rely on the requirements defined in the ISO 17000 series of international standards. Accreditation programs do not verify scientific or technical accuracy of conformity assessment results, but instead examine the process of certification, testing, or inspection bodies.
CERTIFICATION, TESTING, AND INSPECTION BODIES
Certification, testing, and inspection bodies provide a level of consumer confidence in a product. Product certification involves two basic components: evaluation, which may include testing, comparing requirements, and determining compliance; and surveillance, which may include among other things, product inspections and witnessing of production. Certification bodies may also certify (or register) management systems (e.g. quality management systems such as ISO 9000 and environmental management systems such as ISO 14000). This type of certification applies to the management system of an organization only, and does not replace other applicable product certification for quality or safety.
Testing laboratories conduct product tests to specified standards. Testing can be performed by laboratories differing widely in size, legal status, purpose, range of testing services offered, and technical competence. They may be government laboratories, college/university laboratories, independent private sector laboratories, laboratories affiliated with or owned by industrial firms or industry associations, or manufacturers' in-house laboratories.
Inspection bodies typically inspect buildings, facilities, mines, or procedures for quality or safety. Inspection is usually described as "conformity evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging." While the National Conformity Assessment Principles for the United States identify inspection as an activity which is distinct from other types of conformity assessment practices, most other activities involve inspection to some degree.
U.S. REGULATORY AGENCIES
U.S. government agencies use regulations to protect environment, health, safety and national security, and may rely on conformity assessment to ensure that these regulations are met. Each regulatory agency has the authority to decide what level of conformity assessment to require for a specific regulation (e.g. first party, second party, third party) and to decide which bodies, if any, to authorize to do the conformity assessment work. Many U.S. government agencies rely on conformity assessment carried out by private sector bodies.
The first party is generally the person or organization that provides the object, such as the supplier. The second party is usually a person or organization that has a user interest in the product, such as the customer. The third party is a person or body that is recognized as being independent of the person or organization that provides the object, as well as the user or customer of the object.
U.S. PROCUREMENT AGENCIES
U.S. procurement agencies use conformity assessment to ensure that the goods and services they purchase meet relevant standards. Each procurement agency has the authority to decide what level of conformity assessment to require for a specific procurement bid (e.g. first party, second party, third party) and to decide which bodies to authorize to do the conformity assessment work. Many U.S. procurement agencies may rely on conformity assessment carried out by private sector bodies.
U.S. INDUSTRY (PRIVATE SECTOR)
U.S. companies, retailers, manufacturers, and trade associations have a considerable voice in the conformity assessment system and a large impact on what measures are required to compete in the U.S. marketplace. Beyond government regulations, industry ensures that products and services also meet private sector standards, and demonstrates compliance with these standards through voluntary conformity assessment programs. The type of voluntary conformity assessment chosen to demonstrate compliance is determined by the type of product or service, and by the requirements or expectations of the specific purchaser or end-user of the product or service.
PRC Standards System: Introduction
