1. Metrology & Accreditation – Their Role in the Global Market Presented at the 2009 NCSLI Conference San Antonio, Texas 30 July 2009 by Roxanne Robinson NCSLI VP for the International Program

2. Presentation summary Conformity Assessment Explained The path of “Widget” - manufacture to trade… underpinned with metrology Accreditation’s role in trade – conformity assessment once, accepted everywhere

3. Conformity Assessment: The process for determining whether products, processes, systems or people meet specified requirements

4. Conformity Assessment Explained Demands for facilitating trade Trade Organizations & Authorities Product/ service Suppliers Purchasers Regulators Conforming product/service Requirements Market Certification Body Inspection Body Test Lab Cal Lab Conformity assessment bodies Conformity Assessment Service Certification Body Inspection Body Test Lab Cal Lab Conformity assessment bodies Conformity Assessment Service Demands for competent conformity assessment Accreditation Bodies Accreditation service Accreditation Bodies Accreditation service

5. Conformity assessment tools ISO Standards First Party Second Party Third Party Supplier’s Declaration ISO/IEC 17050 * InspectionISO/IEC 17020 *** Testing/ Calibration ISO/IEC 17025 *** CertificationISO 17021/ ISO Guide 65 * AccreditationISO 17011 *

6. Conformity Assessment Tools First party: supplier/user Second party: customer, regulators, trade associations that demand compliance with requirements Third party: Bodies independent from suppliers and customers and having no interest in their transactions

7. Supplier’s Declaration First party conformity assessment Performed by the person or organization that provides the object Usually low risk objects Often supplemented with other forms of conformity assessment Inspection, testing or ISO 9000 certification of the supplier’s management system

8. Can We Rely on Supplier’s Declaration? Perceived risks of non conformity The ease in evaluating the characteristics of interest The magnitude of production or delivery processes, in case of a service The marketplace mechanism for removing non conforming products from the market The effectiveness of penalties for non-conforming regulated products on the market The effectiveness of systems to recall non- conforming regulated products

9. Inspection Used by 1 st, 2 nd and 3 rd parties To examine product characteristics; ensure correct installation of component parts; assess wear and tear of component parts For our “widget”, independent inspectors may use measuring devices to inspect fit, color or wear and these devices must be calibrated by competent technicians to ensure that the inspection specifications are met.

10. Testing 1 st, 2 nd or 3 rd party Labs produce test data that determines whether the product conforms with requirements Test data can relate to a component of the product or the assembled product Test equipment must be calibrated with traceable standards by trained and qualified calibration technicians or there can be no confidence in the test data upon which compliance decisions are made Our widget is tested by qualified technicians using equipment that is properly calibrated and maintained

11. Product certification 3 rd party attestation Always supported by testing of sample from the product lot Includes surveillance to ensure ongoing conformity, by re-testing or re-assessing at prescribed intervals Useful for mass production where characteristics cannot be readily inspected On-product mark or certificate attests to conformity (our widget is marked)

12. Management System Certification Commonly called “Registration” in the States ISO 9001, ISO/TS 16949, QS 9000 relied upon to determine the conformity of manufacturer’s management systems that produce products The widget manufacturer’s measurement system that is part of the management system must be underpinned with appropriate calibration to ensure that the widget meets specification at the time of inspection or test

13. Role of Accreditation Assures the competence of the conformity assessment bodies (labs, inspection bodies, registrars, product certifiers) Accreditation of labs is most widespread type of conformity assessment accreditation As health, safety, environmental and failure cost risks increase for a given product, accredited testing/calibration is often relied upon to supplement other forms of conformity assessment Accreditation requires competent technicians, and calibrated equipment that is traceable to the SI

14. Role of Accreditation Global Users want confidence that proper conformity assessment has been provided to ensure the marketed product meets requirements One reason for repetitive conformity assessment is the lack of user confidence in the CABs and the accreditation bodies that accredit them.

15. Role of Accreditation One way to improve this confidence level is to use the services of CABs that have been accredited by an accreditation body that meets the requirements of a global mutual recognition arrangement (MRA).

16. Role of Accreditation The MRA does 2 things: Ensures the competence of the ABs and the CABS they accredit through a peer evaluation process Requires the recognized ABs to accept and promote the acceptance of data or products from the accredit CABs of their MRA signatory partners “One test, inspection, certification accepted everywhere”

17. Role of Accreditation So our widget… calibrated, tested, inspected or certified in the United States by CABs accredited by an MRA signatory AB… could be distributed globally without the need for any further conformity assessment activities performed by other economies.

18. Role of the Regulator Relying on the ILAC MRA more and more as potential risk to consumers is getting broader exposure, and budgets shrink. The scope of accreditation lends confidence to the regulator when different technical standards are used in different economies. Country B can be assured that a CAB in Country A can competently perform Country B’s test or inspection, if it is on the CAB’s scope of accreditation

19. Conclusion Our widget was manufactured and distributed: Using proper conformity assessment tools Underpinned by competent calibrations Using MRA-accredited organizations Resulting in a level of confidence that ensures wide and successfully use.

20. Serving the Global Market Suppliers get one test, inspection or certification accepted everywhere; CABs get one accreditation accepted everywhere; AB get one recognition accepted everywhere; and Consumers get confidence in the products they buy.

21. Thank you! Roxanne Robinson rrobinson@a2la.org 301 644 3208