Conformity Assessment Key Concepts Standards and U.S. Standards - - PDF document

conformity assessment key concepts standards and u s
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Conformity Assessment Key Concepts Standards and U.S. Standards - - PDF document

1 Conformity Assessment Key Concepts Standards and U.S. Standards & Conformity Assessment System comparison with many other economies Approach in many economies United States Many other economies Bottom Up Top Down Approach in the


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Standards and Conformity Assessment Key Concepts

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U.S. Standards & Conformity Assessment System comparison with many other economies

United States Bottom Up

Standards users drive standardization activities

Many other economies Top Down

Standards bodies drive standardization activities

Approach in many economies Approach in the United States

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U.S. Standards & Conformity Assessment System Reliable - Flexible - Responsive

Market driven

Flexible and sector-based

Industry-led and government-supported

As defined in the United States Standards Strategy

www.us-standards-strategy.org

This system is designed to . . .

  • Support a broad range of stakeholder engagement
  • Address emerging priorities and new technologies
  • Allow stakeholders to find the solutions that best fit

their respective needs

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National Conformity Assessment Principles

(NCAP)

Articulates principles for conformity assessment activities in the U.S.

  • Guidance document to be

considered along with the U.S. Standards Strategy

  • Improves the ability of the

marketplace to understand and have confidence in conformity assessment processes

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Key Terms (per the NCAP)

Conformity Assessment

Demonstration that specified requirements relating to a product, process, system person or body are fulfilled.

Accreditation

Third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. (These tasks include sampling and testing, inspection, certification and registration.)

Certification

Third party attestation related to products, processes, or persons that conveys assurance that specified requirements have been demonstrated.

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Conformity Assessment and Risk

P e r c e i v e d R i s k

Independence and Rigor of Conformity Assessment

Supplier’s Declaration

1st party conformity assessment

Certification

3rd party conformity assessment

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The Conformity Assessment Balance value confidence

for suppliers for acceptance interests

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Confidence/Regulation Spectrum

very regulated unregulated complete trust 100% inspection

paperclip produce pharmaceuticals

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Product/Person/Organization Accreditation bodies Assess competence Conformity assessment bodies Audit/Test/Verify conformity

Accredited 3rd-Party Hierarchy

(ISO/IEC 17011 standard for accreditation bodies)

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IAF

INTERNATIONAL ACCREDITATION FORUM

IAAC

INTERAMERICAN ACCREDITATION COOPERATION

PAC

PACIFIC ACCREDITATION COOPERATION

APLAC

ASIA-PACIFIC LABORATORY ACCREDITATION COOPERATION

EA

EUROPEAN ACCREDITATION COOPERATION

ILAC

INTERNATIONAL LABORATORY ACCREDITATION COOPERATION

International Recognition Bodies