U.S. Conformity Assessment System: 1st party Conformity Assessment
First-party conformity assessment approaches used in the United States include:
Testing
First-party testing may occurr at the end of the design or
production cycle, whereby the responsible party (e.g. the manufacturer,
supplier, or importer) takes the necessary steps to determine that one or more
characteristics of an object comply with the appropriate technical standards
and requirements.
First-party testing is common in internal manufacturing
operations, and serves as a basis for a supplier’s declaration. Second-party testing and third-party testing
are also core elements of conformity assessment.
Testing may include:
- Pre-market design sample testing
- Pre-market production testing
- Post-market product testing, including type testing and random testing
First-party testing may be an appropriate conformity assessment approach when:
- The market demands or allows it
- There is a need to have a factual basis to make a determination of compliance
- It is used to support the supplier’s declaration of conformity
- It is used to support a second- or third-party conformity assessment approach
- The first party has the facilities, such as a testing laboratory, necessary to perform testing
Inspection
First-party inspection is a series of examinations of a
product design, product, process, or installation that determines its
conformity to specific requirements performed directly by the responsible party
(e.g. the manufacturer, supplier, or importer).
First-party inspection 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.).
Inspection can also be performed by a second-party
or a third-party.
First-party inspection may be an appropriate conformity assessment approach when:
- The market demands or allows it
- The first party would like the flexibility and capability to inspect production as needed
- It is used to support a second-party or third-party conformity assessment approach
Supplier's Declaration of Conformity (SDoC)
Supplier's Declaration of Conformity is the procedure by which a first party or supplier conveys assurance that the object of conformity fulfills specified requirements.
While the responsible party designates one individual to be a signatory to the suppliers’ declaration, it is not an uncommon practice that first-party testing and inspection results be voluntarily evaluated by a third party. In certain U.S. industry sectors, regulations specify that these conformity assessment results be evaluated by an accredited third-party conformity assessment body in order to ensure compliance with the appropriate technical standards and requirements.
SDoC may be an appropriate conformity assessment approach when:
- The market demands or allows it
- The risks associated with non-compliance are generally low
- Penalties for non-compliance are effective deterrents
- Options for efficient recourse in the event of non-compliance exist
- The industry sector to which it applies is highly dynamic and has a history of compliance
2nd Party Conformity Assessment
