Conformity Assessment Information

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Conformity assessment includes all activities concerned with determining directly or indirectly that relevant requirements in standards or regulations are fulfilled. Conformity assessment procedures provide a means of ensuring that the products, services, or systems produced or operated have the required characteristics, and that these characteristics are consistent from product to product, service to service, or system to system. Conformity assessment includes: sampling and testing; inspection; certification; management system assessment and registration; accreditation of the competence of those activities and recognition of an accreditation program's capability. A specific conformity assessment process may include one or more of these conformity assessment activities. While each of these activities is a distinct operation, they are closely interrelated. In addition, standards are interwoven into all aspects of these activities and can have a major impact on the outcome of a conformity assessment process. Conformity assessment activities form a vital link between standards (which define necessary characteristics or requirements for products) and the products themselves. Together standards and conformity assessment activities impact almost every aspect of life in the United States. The documents and website links listed below are designed to provide an easy way to access some of the basic information on conformity assessment procedures and issues. In the future, we plan to expand the site to include more information on these topics.

NIST Reports on Conformity Assessment

• The ABC'S of Standards-Related Activities in the United States (NBS IR 87-3576)
  
  
• The ABC'S of Certification Activities in the United States (NBS IR 88-3821)
  
  
• The ABC'S of the U.S. Conformity Assessment System (NIST IR 6014)
  
  
• Laboratory Accreditation as in the United States (NIST IR 4576)
  
  
• The U.S. Certification System from a Governmental Perspective (NIST IR 6077)
  
  
• List of Conformity Assessment-Related Acronyms

Federal Conformity Assessment Guidance

• Final Guidance on Federal Conformity Assessment Activities

NIST Directories of Domestic Certification Bodies

• Directory of U.S. Private Sector Product Certification Programs (NIST SP 903)
  
  
  • SP 903 Introduction
    
    
  • SP 903 Entries A-B
    
    
  • SP 903 Entries C-H
    
    
  • SP 903 Entries I-P
    
    
  • SP 903 Entries R-Z
    
    
  • SP 903 Appendices
    
    
  • SP 903 Indices


• Directory of Federal Government Certification and Related Programs (NIST SP 739 1999 EDITION)

NIST Directories of Domestic Laboratory Accreditation Bodies

• Directory of Federal Government Laboratory Accreditation/Designation Programs (NIST SP 808)
  
  
• Directory of State and Local Government Laboratory Accreditation/Designation Programs (NIST SP 815: 2002 Edition)
  
  
• Directory of Professional/Trade Organization Laboratory Accreditation/Designation Programs (NIST SP 831: 1999 Edition)
  
  
  • Table of Contents & Introduction
    
    
  • Directory

Mutual Recognition Activities - International

• Common Criteria Project is an international initiative by CSE (Canada), SCSSI (France), BSI (Germany), NLNCSA (Netherlands) (CESG (UK), NIST (USA) and NSA (USA) to to develop criteria for evaluation of IT security.
  
  
• International Accreditation Forum (IAF) has developed a mutual recognition scheme for accreditors of quality system registrars/certifiers. IAF is expected to expand the system to include accreditors of environmental system registrars and is considering a scheme in the certification area.
  
  
• International Automotive Task Force (IATF) is an "ad hoc" group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide. IATF members include the following vehicle manufacturers: BMW, Daimler Chrysler, Fiat, Ford, General Motors (including Opel Vauxhall), PSA Peugeot-Citroen, Renault SA, Volkswagen and their respective trade associations - AIAG (U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.) AND VDA (Germany).
  
  
• International Electrotechnical Commission (IEC)
  
  
  • IEC Quality Assessment System for Electronic Components (IECQ) is a comprehensive, world-wide, third-party approval and certification program that assesses electronic components to quality requirements.
    
    
  • IEC CB Scheme (also known as the IECEE Scheme) is a world-wide scheme to allow a manufacturer to obtain a test certificate for a defined product from an approved National Certification Body (NCB). The manufacturer can then present this certificate to NCBs in other countries whose certification marks he wants for his products.
    
    
  • IEC Full Certification Scheme (IEC CB FCS) is based on mutual recognition of the Conformity Assessment Certificates (CACs) issued by its members as the basis for the certification of electrical products at the national and international level.
    
    
  • IEC Scheme for Certification to Standards for Explosive Atmospheres (IECEx) is designed to facilitate international trade in electrical equipment intended for use in explosive atmospheres (Ex equipment).
    
    
• International Laboratory Accreditation Cooperation (ILAC) is developing an ILAC Multilateral Recognition Arrangement for evaluation of laboratory accreditation bodies.
  
  
• International Organization for Legal Metrology (OIML) is developing a voluntary system for mutual recognition of type approvals and verification of measuring instruments.
  
  
• Global Harmonization Task Force (GHTF) is an effort to respond to the growing need for international harmonization in the regulation of medical devices. The five founding members of the GHTF are: Canada, United States, European Union, Japan, and Australia.
  
  

Mutual Recognition Activities - Regional

• European Union (EU) Mutual Recognition Agreement (MRA) Information
  
  
• A [NIST] Guide to EU Standards and Conformity Assessment, NIST SP 951
  
  
• Text of NIST SP 951 (for printing)


• A [NIST] Guide to the EU Low Voltage Directive, NIST GCR 01-812
  
  
• Text of NIST GCR 01-812 (for printing)
  
  
• A [NIST] Guide to the EU Directive on Electromagnetic Compatibility, NIST GCR 01-813
  
  
• Text of NIST GCR 01-813 (for printing)
  
  
• A [NIST] Guide to the EU Machinery Directive, NIST GCR 01-814
  
  
• Text of NIST GCR 01-814 (for printing)
  
  
• A [NIST] Guide to the EU Active Implantable Medical Devices Directive, NIST GCR 01-816



• Text of NIST GCR 01-816 (for printing)
  
  
• A [NIST] Guide to the EU In vitro Diagnostic Medical Devices Directive, NIST GCR 01-817
  
  
• Text of NIST GCR 01- 817 (for printing)



• A [NIST] Guide to the EU Safety of Toys Directive, NIST GCR 01-823
  
  
• Text of NIST GCR 01- 823 (for printing)
  
  
• A [NIST] Guide to the EU Directive Concerning Liability for Defective Products (Product Liability Directive), NIST GCR 01-824
  
  
• Text of NIST GCR 01- 824(for printing)
  
  
• A [NIST] Guide to the EU Directive on General Product Safety, NIST GCR 01-825
  
  
• Text of NIST GCR 01- 825(for printing)
  
  
• A [NIST] Guide to the EU Directive on Radio Equipment and Telecommunications Terminal Equipment, NIST GCR 01-826
  
  
• Text of NIST GCR 01-826 (for printing)
  
  
• The European Organization for Conformity Assessment (EOTC) - this site contains information on conformity assessment in Europe, including a list of notified bodies, information on new approach directive, a list of Conformity Assessment related documents from the European commission Enterprise DG, and other information relate dot conformity assessment.
  
  
• Asian Pacific Economic Cooperation (APEC) MRA Information
  
  
• Inter-American Telecommunication Commission (CITEL) Mutual Recognition Agreement Information

Information on NIST's National Voluntary Laboratory Accreditation Program (NVLAP)

• Visit the NVLAP Web Site

Information on NIST's Laboratory Accreditation Program for State Labs and Related Legal Metrology Activities

• Visit OWM's site for information on the State Laboratory Program and Other Metrology Related Issues

Information on NIST's National Voluntary Conformity Assessment Systems Evaluation (NVCASE) Program

• Information on the NVCASE Program
  
  
• Federal Register Notice on NVCASE Subprogram for Accreditors of Telecommunication Equipment Certification Bodies
  
  

Information on NIST's Measurement Related Conformity Assessment Programs

• Information on NIST's Calibration Services
  
  
• Information on NIST's Accreditation Program for Calibration Laboratories
  
  
• Information on NIST's Standard Reference Materials
  
  
• Information on Standards Reference Data
  
  

Information on the National Cooperation for Laboratory Accreditation (NACLA)

• Visit the NACLA Web Site

Information on Quality System Registration and Related Standards and Activities

• Information on ISO 9000 and Related Quality System Standards

Information on Environmental Management System Registration and Related Standards and Activities

• Information on ISO 14000 and Related Environmental Management System Standards

Certification Information Related to the Use of Fair Labor Practices

• Information on SA 8000 and Other Labor Related Conformity Assessment Programs/Issues

Information on ISO/IEC 17025 - General Requirements for the Competence of Calibration and Testing Laboratories (formerly ISO/IEC GUIDE 25)

• The Accreditation Process According to FDIS 17025 (English) OR (Español/Spanish)

NIST Reports on Foreign Conformity Assessment Bodies/Activities

• Profiles of National Standards-Related Activities (NIST SP 912)
  
  
• Introduction
  
  
• Country Profiles
  
  
• Appendix I and II
  
  
• Standards Setting in the European Union - Standards Organizations and Officials in EU Standards Activities (NIST SP 891)
  
  
• An Overview of the Development of Technical Infrastructure in the Asia-Pacific Region:   The Work of the Asia-Pacific Economic Cooperation (APEC) Sub-Committee on Standard and Conformance (SCSC) an the Specialist Regional Bodies (SRBs) (NIST IR 6325)
  
  
• Free Trade Area of the Americas (FTAA) Conformity Assessment Infrastructure (NIST SP 941)
  
  

Links to Other Sites of Interest

• U.S. Private Sector, International and Regional Conformity Assessment Related Links