1. THIRD-PARTY CERTIFICATION IN THE UNITED STATES Presented by: Joan Sterling

2. In the U.S. product safety is ensured through the efforts of both the public and private sectors Public OSHA – products in the workplace FCC – products connected to the network CPSC – consumer products NHTSA – highway vehicles FAA – air travel FDA – medical devices, pharma. HUD – housing, buildings Coast Guard – marine safety MSHA – mining safety Customs DOE – energy Private NRTLs TCBs retailers, 2 nd party Recognized certifiers and labs Recognized certifiers and registrars Recognized certifiers and labs NRTLs, labs, inspection bodies Recognized certifiers and labs

3. Additionally: Local/regional regulations enforced by local public sector officials Some manufacturers trade associations maintain certification programs Some codes and standards developers maintain certification programs Consumer organization involvement

4. What is Certification? Testing/Evaluation Validation (Conformity Assessment) Monitoring or Auditing  Follow-up Inspections to insure consistency. Marking/Labeling  Identification of certified products.  Standards, Classification, Rating.

5. Levels of Certification: (Private Sector) Self-Declaration  Manufacturer performs testing, validation, and auditing. Affiliated Certification (Trade Associations)  Lab performs testing. Association performs validation and auditing. (Requires autonomous independent administrator to prevent bias toward members.) Third-Party Certification (most stringent, unbiased)  Independent agency performs testing, validation, and auditing.

6. Levels of Certification: Self-Declaration Also called “Supplier’s Declaration of Conformity”. Applicable:  When consequences of non-compliance are considered minor.  When compliance can be readily checked by buyers. Regulations- “Truth in Advertising” laws.

7. Levels of Certification: Affiliated Certification Normally sponsored by trade associations. Allows use of outside labs making it unnecessary for each manufacturer to invest in expensive equipment. Provides a measure of independence between manufacturer and certified performance information. “A level playing field” for competitors.

8. Levels of Certification: Third-Party Certification Must have no connection to product manufacturer, supplier, vendor, buyer or designer. Must be open to audit by accreditors. Usually conducts tests, evaluations, and follow-up production surveillance. Generally required when human safety or property protection is at stake.

9. Levels of Certification: Direct Government Regulation Mandated by Congress. Usually involves areas of high risk.  Liability issues too great for private sector. Allows imposition of civil penalties and criminal prosecution for violations.

10. HOW THIRD-PARTY CERTIFICATION WORKS

11. STEP 1: Identify Product What is the product to be certified? What standard(s) is it to be evaluated by? What are the minimum requirements for acceptance of the product?

12. Step 2: Conduct Evaluation Sample(s) must be traceable to documented design/process. Testing and evaluation under supervision and control of third-party. Full compliance with applicable standards required.

13. Step 3: Create Inspection Documentation Design and process documentation. In-Plant Quality Assurance Procedures. Marking and Labeling Requirements. Certification contract.  Includes “Authorization to Mark”.

14. Step 4: Follow-Up Surveillance Regular and UNANNOUNCED visits to production facilities. Verify that products being “Marked” comply with design, process and QA requirements. Document results and report any deficiencies or deviations. No product modifications without review and verification of compliance by the certifier.

15. IMPORTANT! Without an effective and meaningful FOLLOW-UP SURVEILLANCE PROGRAM the other steps are not effective! (If the producer can submit one product for testing and evaluation and then make and label something different, certification is meaningless.)

16. IF DEFICIENCIES ARE FOUND! 3rd-Party must investigate and determine scope/severity of non-conformity. Determine appropriate remedial actions. If warranted, will suspend or revoke authorization to apply certification mark. Notification of Authorities of unsafe or hazardous products bearing the “mark”.

17. Additional Requirements: 3rd-Party must have procedure to investigate non-compliance allegations from any source. 3rd-Party must have appeals procedure to resolve any issues arising from its compliance or non-compliance determinations. Must have procedure to protect client’s confidential and proprietary information.

18. THIRD-PARTIES ALSO MUST COMPLY WITH STANDARDS ISO/IEC Guides  Guide 23 - Methods for Indicating Conformity with Standards  Guide 27 - Guidelines for corrective action in the event of misuse of the certification mark.  Others (17020, 17025, 43) IAS - Acceptance Criteria and Rules.

19. THIRD-PARTIES ALSO MUST COMPLY WITH STANDARDS ISO Guide 65 - “General Requirements for Bodies Operating Product Certification Systems” ISO Standard 17025, - “General Requirements for the Competence of Testing and Calibration Laboratories”. Intended as the basis for global reciprocity in product certification programs.

20. SUMMARY In order to stay in business, a “Third-party” needs to be trusted by both the seller (1st-Party) and buyer (2nd-Party). Accreditors provide a service designed to provide both 1st and 2nd-Parties with a means of determining the trustworthiness of Third-Parties.

21. Examples of Third-Party Certification Agencies Intertek Testing Services -  Warnock Hersey (1888)  ETL Testing Laboratories (1896) Underwriter’s Laboratories - UL (1894) Factory Mutual Research Corp. - FM (1941) Canadian Standards Association - CSA(1919) National Sanitation Foundation - NSF (1944)

22. WHAT DOES IT ALL ACCOMPLISH?

23. AND: “a level playing field” for fair competition.

24. THANK YOU! Web: www.etlsemko.com joan.sterling@intertek.com