1-1 Supplier Declaration of Conformity (1-1SDoC)
12.10.2006
One Standard - One Test, Supplier's Declaration of Conformity:
A Balanced Approach to Regulating Global IT Markets
Background:
Worldwide, the information technology (IT) industry has a proven track record of providing safe, high quality, state-of-the-art products. The industry has worked closely with government groups and formal standards setting bodies to develop internationally recognized standards in areas such as safety and electromagnetic interference (EMI). Nearly all governments that regulate IT have adopted these international standards. As a result, this global alignment has greatly facilitated international trade. However, the proliferation of unique regulatory requirements for conformity assessment is now diminishing the benefits of these shared standards.
Many of these requirements are more trade restrictive than necessary to fulfill legitimate regulatory objectives. Suppliers must put their products through repetitive tests that provide no additional benefit to customers or to societies. Redundant testing and certification increase customer costs, limit choice, and can delay market entry—in many cases, by weeks or months. Given the short life cycle of information technology products, this is a significant impact. Accordingly, those countries currently implementing unique IT conformity assessment requirements have the most to gain by minimizing this regulatory intervention. Doing so will open up innovation and competition among businesses and better ensure that the benefits of IT reach consumers and the community in the most efficient way.
One Standard-One Test, Supplier's Declaration of Conformity (1-1SDoC):
1-1SDoC offers IT regulators a way to meet their objectives in the least trade-restrictive manner. It is the appropriate approach to take, based on the low risk of IT products in regulatory areas such as product safety and EMI. It also allows governments to direct scarce resources to specific products they identify as the most likely to require regulatory attention, while eliminating redundant requirements that prevent innovative IT products from reaching consumers most efficiently.
This model has three stages: (1) the supplier’s declaration of conformity to one standard proven by one test performed by a competent (e.g., accredited) laboratory (2) relevant, post-market surveillance to detect potentially non-compliant products and (3) penalties on manufacturers whose products are found not to comply. When implemented as part of this unified process, 1-1SDoC preserves legitimate regulatory objectives while maintaining a role for certification and accreditation bodies, which can offer expert, value-added services. With 1-1SDoC, manufacturers may voluntarily choose to use third party testing and certification services on an efficient, market-driven basis.
1-1SDoC Policy
One Standard: Acceptance of an international standard (e.g. IEC 60950 for safety of IT equipment or CISPR 22 for electromagnetic emissions), or national standard with stated equivalency.
One Test: Acceptance of test results conducted in any competent test facility (e.g., conforming to ISO/IEC 17025, accredited to ISO/IEC Guide 58, member of MRA, and/or IECEE CB Scheme member) regardless of the facility’s geographic location.
Supplier's Declaration of Conformity: Products may be marketed on the basis of a supplier's declaration of conformity that complies with ISO/IEC Guide 22 (to be superceded by ISO/IEC 17050 Part 1 and 2). The supplier shall retain compliance documentation (i.e., description of product, test reports, etc.) providing the basis for the supplier's declaration and make it readily available to the regulator upon request. Enforcement of regulatory requirements will be by means of post-market surveillance and non-compliance penalties.
Examples of 1-1SDoC for EMI and safety regulations can be found in the U.S. (EMI), EU member states (both), Canada (EMI), Australia (both), and New Zealand (both).
Key Points:
· “Over-built” regulatory systems burden regulators, consumers and manufacturers.
· The biggest hurdle to move toward 1-1SDoC is “political will.”
· Regulators can introduce 1-1SDoC by a STEP function or a PHASED APPROACH.
· Regulators can have confidence in SDoC through “accreditation” or “CB peer assessment” of test labs, by ISO/IEC 17050 standards for SDoC and supporting documentation, and by consumer education and market surveillance.
· Manufacturers will still obtain 3rd party testing and certification for market reasons, even if no longer mandated by regulation.
· 1-1SDoC can be successfully applied to IT EMI and safety regulations.
ITI is available to work with national regulatory organizations in developing strategies toward the implementation of a 1-1SDoC policy. We welcome the opportunity to present a more detailed overview, answer related questions, discuss alternatives, and facilitate contact with regulators in other countries moving in this direction.
|
