If your organization is selling product in the global market, it is essential to understand the importance of product testing, regulatory compliance, and product certification in the destination countries. Depending on the country or region, certain product compliance approval certifications are mandatory. Testing your products for regulatory compliance requirements benefits importers and exporters because certification provides quality assurance to the market in which the products are being sold, helping to increase competitive advantage, and significantly reducing unintended costly product liabilities.
Before completing the design of your product in accordance with the standard's requirements, you have to determine what proof you need to show that it complies with intended standards. Which type of Safety Approval you need depends on your answers to questions such as:
• In which countries do you want to sell the product, now and in the future?
• What are the national deviations for the countries where you will sell the product?
• Is compliance mandatory in the target market?
• If not mandatory, would it be advisable for product liability reasons?
• If not mandatory, would it be advisable for marketing reasons?
• If mandatory, is approval by a specific test house required?
• Can compliance be shown on the basis of self-declaration?
• What material is needed to justify self-declaration?
Basic types of safety approvals
IECEE CB Scheme: The CB Scheme is the international system for acceptance of test reports dealing with the safety of electrical and electronic products. It is a multilateral agreement among participating countries and certification organizations. A manufacturer utilizing a CB test report issued by one of these organizations can obtain national product certification in all other member countries of the CB Scheme.
The Scheme is based on the use of international (IEC) Standards. The CB Scheme utilizes CB Test Certificates to attest that product samples have successfully passed the appropriate tests and are in compliance with the requirements of the relevant IEC Standard and with the declared national differences of various member countries.
Certification Test Mark(s): The test house will test the product, and if compliant, will give you a license to put THEIR Certification 'MARK' on each item of the product you ship. This generally involves paying an annual license fee, as well as periodic visits to your production facilities to ensure that the product you are selling is identical to the product tested.
Technical Test Report: The test house will test the product sample(s) you submit. If the samples are compliant, they will issue you a Test Report (and Attestation of Conformity Certificate if requested) in regard to the compliance of those samples tested. Use the Test Report (and Certificate if applicable) as justification for self-declaration in situations where this is acceptable, e.g. for the Low Voltage Directive in the European Union.
Preparing for a safety evaluation
In addition to one or more samples for testing, you will be asked to submit the following materials to the test house:
• Name, address, phone/fax numbers and email addresses of contact(s) for the applicant, responsible manufacturer and the manufacturing facilities
• Product operating specifications
• Product schematics
• Assembly drawings
• Parts list
• User's manual
• Installation guide
• Data sheets, approval certificates and CB reports of safety-critical components
• Location of circuits, which must be separated, on a printed circuit board; a copy of the PWB layout transparency, marking the separate circuits.
Safety-critical components are those that can affect safety. These include all components in primary circuitry and any other component, the failure of which can affect safety.
The test house will need to see the approval licenses for safety-critical components in order to ensure that they were approved to an appropriate standard, and that they are used in accordance with any conditions specified in the approval license. If components are not previously certified, you will bear the cost of approving the component for use in the product, as well as ensure that the manufacturer does not change the component specification.
The manufacturer, model number, operating characteristics, and compliance standard(s) of safety-critical components will be recorded in the test report. It is advantageous to have second sources of safety-critical components recorded at the time of the testing to save the cost of including them at a later stage.
Course of a product safety investigation
The engineer in charge of the investigation will carry out a constructional review of the product. If there is any nonconformity, you will be sent a deviation letter, listing the problems and asking for your response. Depending on the problems, the response may be a declaration that changes will be made (e.g. to documentation or markings), or may involve alteration of the product design and resubmittal.
Once the issues are resolved, the product will be tested in accordance with the tests that the engineer considers relevant to your product. Once again, you will be notified of any nonconformity.
Laboratories that are accredited to ISO/IEC 17025 or EN 45001 are committed to allow you to witness your product's testing. The standard cannot cover all situations, and the engineer has to interpret the standard's requirements for your particular product. You certainly know your product better than the engineer, and your interpretation may be different. A well-argued response, based on the standard and sound engineering judgment, may prevent the need for product changes.
Once all issues are resolved, and the engineer has all the documentation he needs, he will complete the test report and certificate. Verify all the details on the certificate and test report are correct.
It is good practice to have a person responsible for reviewing any changes to your product from a compliance point of view. This person should sign off every change to the product and contact your test house to see whether retesting is necessary or a revision is required to the test report. If you are subject to factory visits, the inspector has the right to revoke your license to 'mark' the product if it differs from the product tested. A particular source of problems is the substitution of safety-critical components.
Time-saving and cost-cutting techniques
Assign one person in your company to be your liaison for certification matters
This isn't a requirement, but it makes good business sense. Your company contact person will gain valuable knowledge about standards and certification, help promote continuity, and provide a constant connection between your organization and the Certification Agency.
Get to know the standards
Determine the standards that apply to your product in your target markets, and learn the specific requirements.
Pre-test your products
Early testing in-house or by a testing facility can help you identify problems that might delay product certification. An added benefit to using an accredited testing facility is that early test results might be used later in the certification process, provided the requirements remain unchanged.
Provide supporting material
When submitting your test samples, include supporting materials such as detailed data sheets, marketing and sales materials, photographs, and instructions for use in either hardcopy or electronic format.
Ask the experts
Take advantage of any Preliminary Product Review Programs offered by the testing house. Using such a program gives you access to experts who will examine specifications and prototypes, advise you on standards, and provide practical training for your product team.
Use components that are certified by Accredit Organizations for the intended market
Take full advantage of the proven track record of your components by identifying all components that are already certified by CB Scheme, TÜVs, VDE, UL, CSA, NEMKO, etc.
Keep in touch
Contact the test house if you have problems at any stage. The testing facility should be able to help clarify requirements or suggest other approaches permitted by the standard.
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