Conformity Assessment Requirements to Access the U.S. Market - An Overview - Steven Bipes Program Manager – Regional & Bilateral Policy

Components of Conformity Assessment Metrology and measurement capabilities Sampling Testing Inspection Declaration of conformity Certification (products, services, personnel) Management system registration/certification Accreditation Enforcement

Who Conducts Conformity Assessment in U.S.? First Party – Manufacturer or Supplier (Supplier’s Declaration of Conformity) Second Party – Buyer Third Party – Party Independent from Buyer or Seller

Key Characteristics of U.S. System In the United States, conformity assessment activities are not centrally organized Activities are a mix of government (regulations) and private sector (market activities) Approaches vary among sectors

Product Certification in the United States Largely a private sector activity - based on customer and market demand There are many industry programs Government agencies can also play a variety of roles Direct Certification (FDA, USDA) Recognition of Third Party Certifiers (FCC) Recognition of Manufacturer’s Declaration of Conformity (FCC)

Federal Government Certification Programs Programs fall into several general categories: Programs to Certify Products which affect Health / Safety of User / Public (Mandatory) Programs to test products to avoid necessity for retesting prior to each procurement (Procurement) Programs to provide a uniform basis for trade by accessing the quality / condition of products offered for sale (Voluntary)

Federal Government Certification Programs There are about 30 Federal programs in various agencies: Department of Agriculture: food safety, grain inspection, etc. EPA: drinking water, vehicle emissions, etc. NIST: laboratory accreditation required by FCC, HUD, DOE, EPA, NRC, etc. HHS: Drug testing, Safety Data, Milk Safety, etc.

State and Local Government Programs There are many state, local and municipal programs building/construction environmental electrical/electronic food and agriculture consumer products

INDUSTRY PROGRAMS DESIGNED TO Enhance industry reputation Provide Manufacturers with some assurance on Safety, Environmental Impact, or Compliance with Requirements Establish Minimum Level of Safety / Quality / Environmental Performance for some products Avoid need for Government Involvement

Private Sector Programs Approximately 200 non-government organizations operate product certification programs: many organizations certify products to meet government requirements programs may be operated by trade associations, professional societies, independent testing/inspection bodies, consumer organization, and sector- specific organizations may operate domestically, internationally, or both

ACCREDITATION of CERTIFIERS  U.S. Accreditation system for certification programs is less complex  Only a few major programs  ANSI operates the largest private sector accreditation program for certifiers  ANSI-RAB National Accreditation Program (NAP) is the U.S. accreditation body for ISO 9000/14000

ACCREDITATION of LABORATORIES  Historically no central organization and no recognition among programs  Most U.S. programs designed to meet specific sector or regulatory needs  About 60 State / Local / Federal programs  Also roughly 38 private sector programs  Great deal of variability among different programs

Quality Management System Registration Significant marketplace factor for some sectors Registration not mandatory for any U.S. government regulatory program Used by some U.S. government agencies internally, i.e., NASA, FAA procurement function

Streamlining Laws passed by US Congress in 1996 – Regulatory Streamlining – NTTAA (DoD, FCC) FCC Streamlined by retaining responsibility but delegating actions to private sector in: – Laboratory Testing – Product Certification – Determination of Administrative Procedures – Standards Development (changed federal regulations to pointers to a voluntary consensus standards (ANSs from ANSI Accredited SDO)

 ISO/IEC Guide 65  ISO/IEC Guides 62 & 66  ISO/IEC ANSI Accreditation Programs

Verification (Self-approval) Verification (Self-approval) Certification (Approved by FCC or TCB) Certification (Approved by FCC or TCB) Declaration of Conformity (Self-approval using an accredited lab) Declaration of Conformity (Self-approval using an accredited lab) FCC Equipment Authorization Program The type of approval is specified in the rules for the particular type of device

Equipment Authorization Application Trend Private Certification Bodies FCC Trends – TCB vs. FCC grants Applications Private CBs: conduct routine testing FCC Lab: resources devoted to technically complex certification and support of Commission items.

CONCLUSION  U.S. System is complex and uses industry sector approach  Conformity Assessment system, like Standards system, evolved in decentralized manner  Based largely on Supplier’s Declaration of Conformity for Products / Services sold in U.S. Marketplace  Also relies on industry self-regulation  Government agencies and private sector both very involved in U.S. system  Is generally effective, open, and transparent

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