1. 5/17/02month ##, 2002 Page 1 CA 101 Supplier’s Declaration of Conformity David Ling Regulatory Policy Manager Hewlett Packard Company October 15, 2002

2. 10/24/2015 Apec 4 th conference2.ppt Page 2 Supplier’s Declaration of Conformity Product, process, service or management system Specified requirements, which may include normative documents such as standards, guides, technical specifications, laws and regulations Assessment or testing (e.g. test, audit, inspection or examination) carried out by a first, second or third party SDoC definition: First-party attestation of a product, process or management system conformity based on first-, second- or third-party test. SDoC should not to be interpreted as reducing the responsibility of the supplier in any way. “THING” “SPEC” “STATEMENT” “TEST”

3. 10/24/2015 Apec 4 th conference2.ppt Page 3 Market-driven vs. Regulatory Application of SDoC. SDoC is a proven and accepted way to assure conformity in both the regulatory and non-regulatory application. Market-Driven. Drivers are CUSTOMER SATISFACTION, COMPETITIVE ADVANTAGE and COST CONTAINMENT Possibilities include: –(1) No statement (2) SDoC (3) Third-party certification (4) Whatever it takes to satisfy customer Regulatory: Drivers are LEAST TRADE RESTRICTIVE, TIME-TO-MARKET and COST CONTAINMENT Options include: –No regulations (instead, use incentives) –Third-party certification and Pre-market approvals –SDoC and Post-market surveillance

4. 10/24/2015 Apec 4 th conference2.ppt Page 4 Benefits of SDoC use in Regulations Remove duplicative testing and pre-market certification Simplify complex administrative requirements Facilitate global trade Put schedule into the manufacturer’s control

5. 10/24/2015 Apec 4 th conference2.ppt Page 5 Maintains Protection Continued strong protection of consumers through: use of well-developed international standards competent testing strong accountability and smart enforcement SDoC does not mean: No testing No enforcement

6. 10/24/2015 Apec 4 th conference2.ppt Page 6 Common elements of a Regulatory Application of SDoC A number of government regulations allow for SDoC. These regulations have common elements. Req’t Spec SDoCAccountable Party Qualification Test Compliance Folder Product Marking Enforcement Means

7. 10/24/2015 Apec 4 th conference2.ppt Page 7 Important Role of Post-Market Surveillance Conducted by governments or quasi-governmental agencies Consists of audits, spot checks, investigations triggered by field complaints, legislated reporting requirements Can be as effective as pre-market requirements

8. 10/24/2015 Apec 4 th conference2.ppt Page 8 Conducting Surveillance Regulators should have authority and ability to: Obtain SDoC, contact the accountable party Obtain substantiating documents (“compliance folder”) and review for signs of trouble If necessary, conduct follow-up tests Enforce penalties if product is non-compliant

9. 10/24/2015 Apec 4 th conference2.ppt Page 9 SDoC has a Variety of Application Motor vehicles in Canada and the US Aeronautics in Canada European Union Low Voltage Directive Electromagnetic Compatibility (EMC) Directive Radio and Telecom Terminal Equipment Directive U.S. Federal Communications Commission Electromagnetic interference Wireline terminal attachment Other EMI: Canada, Australia, NZ, Japan, Taiwan

10. 10/24/2015 Apec 4 th conference2.ppt Page 10 Examples of Regulatory Application of SDoC in Asia Pacific Information Technology EMI regulations in the 21 APEC member economies Third-party certification and Pre-market requirements No regulations yet SDoC and post-market surveillance

11. 10/24/2015 Apec 4 th conference2.ppt Page 11 SDoC and Post-Market Surveillance Preferred IF each of the 21 APEC member economies mandated unique third-party certification and pre-market requirements …. 210 bilateral agreements needed to facilitate trade. Number of bilateral agreements = n (n-1)/2 210 = For 21 APEC members Bilateral Agreement Model

12. 10/24/2015 Apec 4 th conference2.ppt Page 12 References Specific references ISO/IEC Guide 22 and ISO/IEC 17050 [under development]. General Requirements for SDoC ISO/IEC 17049 [under development]. Requirements for supporting documentation for a supplier’s declaration of conformity Req’t Spec SDoCAccountable Party Qualification Test Compliance Folder Product Marking Enforcement Means General reference WTO Technical Barriers to Trade Agreement ISO/IEC Guide 2 and ISO/IEC 17000 [under development]. Conformity assessment — Fundamentals and vocabulary