Welcome to ANSI’s World Accreditation Day Webinar June 9, 2014 PLEAS E NOTE: Everyone is MUTED; please send questions via “ Questions” option S lides will be made available after today’ s session Lane Hallenbeck Q & A follows the presentations ANS I Vice President Accreditation S ervices
Thanks for Your Participation All webinar participants are muted If you are participating via laptop, you may need to adj ust the sound on your computer If you hear an echo, please hang up and dial in again If the webinar slides do not display, please check that you have installed the software correctly – you may need to reinstall S lide 2
Webinar Protocol Questions Will be answered as time allows at the end of all presentations Use the “ Q&A” option and type a brief question All other questions may be sent to kcalder@ ansi.org If anyone has a problem during the webinar, please send an e-mail to kcalder@ ansi.org S lide 3
The ANS I Federation represents more than 125,000 companies and organizations and 3.5 million professionals worldwide. Members of the ANSI Federation include . . . Academia Professional S ocieties Individuals S ervice Organizations Government S tandards Developers Manufacturing Consumer and Labor Interests Trade Associations and many more S lide 4
ANSI Collaboratives and Workshops 2004 2005 2006 2007 1994 2003 Nanotechnology Healthcare ID Theft Prevention Biofuels S tandards Information Homeland Defense S tandards Information and ID Management Coordination Infrastructure and Security Panel Technology S tandards Panel Panel S tandards Panel S tandardization S tandards Panel Collaborative 2012 2007 2009 2009 2010 2011 2013 ANS I ANS I Network on Workshop Toward ANS I-NIS T Nuclear The Financial ANS I ANS I Workshop: Chemical Product Standards Energy S tandards Management of Electric Vehicles Energy Efficiency Smart and S tandards Coordination Regulation for Sustainability Coordination Cyber Risk S tandards Panel Sustainable Collaborative Collaborative Cities S lide 5
International Conformity Assessment Standards Development and Oversight Lane Hallenbeck Chair – IS O CAS CO (Conformity Assessment Committee) lhallenb@ ansi.org
ISO CASCO Structure S lide 7
Global Supply Chain Confidence? Trust? Cost? Risk? 3 rd Party SDoC S lide 8
Value of Accreditation ISO/IEC 17011 S lide 9
Accreditation bodies Assess competence Conformity assessment (CA) bodies Audit/ Test/ Certify/ Verify conformity Object of CA (Product, Person, Organization, etc.)
Oversight of Accreditation Bodies The role of the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) Keith Greenaway Vice President ANS I-AS Q National Accreditation Board kgreenaway@ anab-aclass.org
ANSI-ANAB-ACLASS-FQS Accreditation Programs Standards S tandards Developer ANS I Essent ial Requirement s U.S . Technical Advisory Group ANS I International Procedures Certificate Issuer AS TM E2659 Product Certification Body IS O/ IEC 17065 Conformity Assessment Greenhouse Gas Verification Body IS O/ IEC 14065 Personnel Certification Body IS O/ IEC 17024 Management S ystem Certification Body IS O/ IEC 17021 Laboratory IS O/ IEC 17025 Inspection Body IS O/ IEC 17020 Proficiency Test Provider IS O/ IEC 17043 Reference Material Producer IS O Guide 34 Medical Laboratory IS O 15189
Certified Once… Accepted Everywhere S lide 13
lide 14 Tested Once… Accepted Everywhere S
A User’s Experience: The U.S . Testing and Certification Infrastructure and Michael Violette Importance of IS O Director S tandards American Certification Body mikev@ wll.com
Presentation Overview U.S . Testing Infrastructure Types of Labs in the U.S . Capacity Management & IS O Finance Issues S lide 16
Presentation Overview U.S . Testing Infrastructure Types of Labs in the U.S . Capacity Management & IS O Finance Issues S lide 17
Lab Infrastructure Public-S ector Labs (U.S . Government) Private-S ector Labs S lide 18
Federal Activity in Laboratory Testing Commerce/ NIS T FDA FCC (TCB Council) DOL/ OS HA DOD EPA CPS C DHS S lide 19
Private Sector: Classification of Laboratories (American Council of Independent Labs— ACIL) Conformity Assessment Environmental S ciences S ection Food S ciences S ection Construction Materials, Engineering, and Testing S lide 20
CAS Projects S mart Grid Interoperability China Conformity Assessment S ystem TBT Policies and Practices Position statement Proficiency Testing Program Third Party Certifier Activities DOJ Offender Tracking Program S lide 21
Public-Sector Labs NAS A National Institutes of Health National S cience Foundation National Institute of S tandards and Technology Naval Research Laboratory Biometric Consortium National Energy Research S cientific Computing (NERS C) Army Research Lab Topographic Engineering Center (TEC) Environmental Measurements Laboratory *National Renewable Energy Laboratory (NREL) *Oak Ridge National Laboratory *Lawrence Berkeley Laboratory *Los Alamos National Laboratory *Dept of Energy *S andia National Laboratories $4.9B in Research *Brookhaven National Laboratory *Lawrence Livermore National Laboratory *Argonne National Laboratory *Fermi National Accelerator Laboratory *Pacific Northwest National Laboratory S lide 22
lide 23 S
Public-Sector Labs (non-research) Environmental Monitoring and Compliance Labs EPA Virginia Division of Consolidated Laboratories S ervices Analytical S ampling for local governments, federal agencies 6 million tests per year Accredits other laboratories S lide 24
Private-Sector Labs Many (most) deal with compliance to regulatory requirements Protection of People and S ervices Health and S afety Electrical and Mechanical S pectrum & Communications Environmental Protection Air & Water S lide 25
Laboratory Business Many private labs started as small businesses: engineers, chemists, scientists Develop niche capability Regional markets Many labs build capacity through acquisition Most labs generate $120,000 per employee S lide 26
Simplified Regulatory Structure in the U.S. Federal Government S tates Communications Health, S afety & Environment Local Authorities National Defense International Agreements Inspectors Manufacturers S lide 27
U.S. Regulatory Authorities U.S . Department of Agriculture (US DA) Domestic and Imported Meat Poultry Eggs Establish Ingredient S tandards and Approve Recipes and Labels for Processed Meat and Poultry Products S lide 28
U.S. Regulatory Authorities Environmental Protection Agency Water and Air Quality Pesticide Approval and Registration Establish Tolerances for Pesticides FDA and US DA Enforces Pesticide Tolerances S lide 29
U.S. Regulatory Authorities Food and Drug Administration Foods Drugs Cosmetics Medical Devices Veterinary Drugs and Feeds Biological Products Radiation Devices S lide 30
Food Safety Concerns in the news Food S afety Modernization Act signed into Law: 4 January 2011 S lide 31
U.S. Regulatory Authorities Federal Communications Commission (FCC) Control use and protection of Radio Frequency S ervices for Public S lide 32
U.S. Regulatory Authorities Occupational Health & S afety Administration (OS HA) Workplace S afety NRTL Program S lide 33
Code of Federal Regulations (50 titles from Food to Nuclear Power) http:/ / www.gpoaccess.gov/ CFR/ S lide 34
Presentation Overview U.S . Testing Infrastructure Types of Labs in the U.S . Capacity Management & IS O Finance Issues S lide 35
Spending: Department of Energy 17 Government Labs providing basic research in physics, chemistry and material sciences Budget: $4.9B (40% of total is R&D) National S pending: $12B S lide 36
Market Size: Product Testing (not foods) 600+ (mostly) private providing testing services for equipment manufacturers Estimated market size: $1.8B S lide 37
Market Size: Conformity Assessment Labs 114 Accredited Labs on FCC Website 31 in California 6 in Massachusetts & Minnesota 5 in New York 4 in Maryland, Texas, Washington S tate & Illinois Regionally distributed S lide 38
Market Size: Environmental 1600 labs providing environmental analytical services Market size $2.4B S lide 39
Presentation Overview U.S . Testing Infrastructure Types of Labs in the U.S . Capacity Management & IS O Finance Issues
Processes Lab Management: Quality S ystems Accreditation requirements drive processes Quality S ystems: IS O 17025, IS O 17065, and related S lide 41
Recommend
More recommend
