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U.S. Conformity Assessment System:   3rd Party Conformity Assessment
Conformity Assessment

Third-party conformity assessment approaches used in the United States include:

Third-party Testing

Third-party testing may occur at the end of the design or production cycle, whereby an independent testing laboratory takes the necessary steps to determine that one or more characteristics of an object comply with the appropriate technical standards and requirements. Testing laboratories are qualified as independent in that they do not possess an interest in the person or organization that provides the object for conformity assessment or any user interests in that object.

Third-party testing may be an appropriate conformity assessment approach when:

  • The market demands or allows it
  • The risks associated with non-compliance are high
  • There is a need to have a factual basis to make a determination of compliance.
  • The first party and/or second party would like to provide users with an added level of confidence in the object of conformity assessment system
  • It is required by a 3rd party certification body to help determine if products comply with requirements
  • It is required by U.S. regulations to fulfill the requirements for a supplier's declaration of conformity
Testing can also be performed by a first-party or a second-party and is the most commonly used conformity assessment activity.

Third-party Inspection

Third-party inspection is a series of examinations of a product design, product, process, or installation that demonstrates its conformity to specific requirements and that is performed by an independent inspection body. Inspection bodies are considered independent when they do not possess an interest in the person or organization that provides the object for conformity assessment or any user interests in that object.

Third-party inspection bodies may typically inspect against a wide range of functions (e.g. products, services, materials, installations, plant processes, work processes, etc.) and parameters (e.g. quality, quantity, safety, fitness for use, etc.).

Third-party inspection may be an appropriate conformity assessment approach when:

  • The market demands or allows it
  • The risks associated with non-compliance are high
  • The first party and/or second party would like to provide users with an added level of confidence in the object of conformity assessment
  • The first party and/or second party wish to rely on an independent entity to determine and/or share tasks related with compliance

Inspection can also be performed by a first-party or a second-party.

Certification/Registration

Certification is a third-party attestation declaring that specified requirements pertaining to a product, person, process, or management system have been met. The certification of management systems is sometimes referred to as registration. In addition to being conducted by an independent party, a characteristic of certification is that it often involves an element of surveillance. Once something is certified as compliant, it may be subject to the continuing verification by the certifier of its compliance both before and after it reaches the market (pre-market and post-market surveillance).

Certification may be an appropriate conformity assessment approach when:

  • The market demands or allows it
  • The risks associated with non-compliance are high

Accreditation

Accreditation is a statement from an accreditation body – an independent third-party entity – declaring that specified requirements related to conformity assessment bodies have been met and that the accredited body is competent to perform certain functions. Accreditation bodies conduct evaluations based on the following internationally recognized criteria:

The accreditation bodies themselves demonstrate their competence through adhesion to the international criteria specified in ISO/IEC 17011 and may also be subject to peer review, performed by regional and international accreditation organizations.

Testing laboratories, certification bodies, and inspection bodies may choose to be accredited in order to provide their clients and other stakeholders (e.g. manufacturers, suppliers, users, governmental and regulatory agencies, etc.) with additional confidence in their competence. Choosing to be accredited may also give these conformity assessment bodies a competitive advantage, especially in high-risk sectors, and improve the recognition of their conformity assessment results internationally.

Certification from an accredited conformity assessment body may be an appropriate conformity assessment approach when:

  • The first party and/or second party partake in extensive cross-border trade
  • The risks associated with non-compliance are high
  • The first party and/or second party would like to provide users with an added level of confidence in the object of conformity assessment

In the United States, some accreditation bodies include:


Key Organizations  next