5/17/02month ##, 2002 Page 1

CA 101

Supplier’s Declaration of Conformity

David Ling

Regulatory Policy Manager

Hewlett Packard Company

October 15, 2002

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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”

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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

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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

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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

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Common elements of a Regulatory Application of SDoC

A number of government regulations allow for SDoC.

These regulations have common elements.

Req’tSpec

SDoC AccountableParty

QualificationTest

ComplianceFolder

Product Marking

EnforcementMeans

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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

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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

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SDoC has a Variety of ApplicationMotor 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

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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

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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

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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’tSpec

SDoC AccountableParty

QualificationTest

ComplianceFolder

Product Marking

EnforcementMeans

General reference

• WTO Technical Barriers to Trade Agreement

• ISO/IEC Guide 2 and ISO/IEC 17000 [under development]. Conformity assessment — Fundamentals and vocabulary