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Conformity Assessment

Manufacturer's Role

The following identifies what a product manufacturer typically needs to provide during the product safety evaluation process. Actual requirements will differ depending on the type of product and evaluation desired. Safety organizations such as UL and TÜV evaluation processes are similar, but have different documentation requirements and some support documentation may need to be completed when obtaining a cost estimate.

Needed to provide a cost estimate:

• Name and address of the manufacturer.
• Manufacturer contact person(s), phone, fax, and email.

  Normally project activities can be coordinated more efficiently by designating a primary contact person. Often this person could be a project engineer, project manager or safety engineer.

• All model names the product will be sold under.

  When a family of products are developed with different model names, typically only the worst case model(s) will be evaluated and tested. All model names need to be identified to understand the extent of the project, and to be included on certification documents and reports.

• Name and address of production factory(s) if different from manufacturer.

  All intended factories should be identified. Factory address will be listed in reports and on certificates. Adding a factory to NB or NRTL reports and certificates after the project has closed is expensive. NRTLs and NBs require factories to be inspected before their mark can be placed on the product. Factory contact information must be provided.

• Description of the product's intended purpose and function.

  This can be addressed with a product brochure, manual or other document that describes the basic operation.

• Product manual or preliminary manual or manual for similar product. *

  Often manuals are not available at the early stages of a product development. However a copy of the operators manual and possibly a service manual will be required before the completion of an evaluation to review required safety information. To help with the product evaluation and manual evaluation process, a draft manual or manual of a similar product can be helpful early in the project.

• Schematics and/or functional block diagram.

  Even if still in development, schematics and/or block diagrams identifying power distribution, assemblies, major functions and I/O can be very helpful.

• Power requirements.

  Identify AC and/or DC input voltage and/or other sources of power required, such as; pneumatic, hydraulic, UPS, etc.

• Identification of product potential hazards:

  Identification of product hazards is important in order to identify costs associated with safety tests and product requirements. Examples of potential product hazards are: lasers, LEDs especially IR and UV or similar light sources, Ionizing radiation, non-ionizing radiation and chemicals, electrical, mechanical.

• Identification of product I/Os.

  Identification of product I/Os are important in order to identify costs associated with safety tests and product requirements. Examples of I/Os are: Ethernet, telecommunication, fiber optic, video, audio, antenna, parallel and serial ports, IR remote control or RF interface, etc.

• Identification of accessories to be sold with the product.

  Accessories could include external power supplies, cables, peripheral devices, etc.
  Some accessories may have safety issues that need to be evaluated with the product.

• Product specifications. *

  As with the product manual, complete product specifications are not always available at the start of a project. Some information must be provided if an accurate cost estimate is desired. As identified above, power requirements, product hazards and I/Os are important for determining what standards apply, the scope of testing needed and complexity of the product, all of which will affect costs.

• Identification of intended markets, countries and desired certification.

  The type of certification needed often will be driven by the market that a product will be sold into or driven by the customers of the end product. Some industries in Europe may require a Notified Body Mark or CE marking alone may be all that is required. Or due to competitors a manufacture may choose to have NRTL and/or Notified Body certification. Some safety organizations are both a NRTL and a Notified Body, and can offer certification for North America and Europe. Additionally a CB report may be helpful when marketing products in different parts of the world. Not all NRTL and Notified Bodies offer CB reports.

  The type of certification needed and support documentation requirements should be studied carefully at the start of the conformity assessment process.

Needed to open a project:

• PO for the cost estimate price.

  Safety thru Design, Inc., other safety organization, NRTLs, and NBs require a PO and in some cases a deposit before opening a project.

• Production schedule. *

  Providing the production schedule can help all parties involved in the evaluation to schedule and prioritize their tasks.

• Samples that represent the final product. *

  Before a sample is available a preliminary design review can be conducted to identify how product hazards will be addressed. Safety critical components can be identified, support documentation reviewed and safety tests identified. Conducting these activities prior to approaching a NRTL or NB can save time.

Needed before completion of a project:

• Samples that represent the final product.

  Evaluation and testing must be performed on a sample that represents a production unit.

• Final Operator and Service manual.

  Must be reviewed for appropriate safety information. If shipping into the EU, safety information must be translated into the country of intended use.

• Component support documentation.

  Safety critical component manufacturer data sheets, licenses and certificates will be needed by NRTLs, NBs, and for a CE marking technical data file. In some cases safety reports for assemblies such as power supplies will be needed.

• Product, schematics, mechanical drawings, and other support documentation.

  Final documents showing features related to product hazards will need to be reviewed by NRTLs and NBs, and will be kept on file.

* Note: Optional items that could be required later in the process.

Project Time Frames:

Time to complete a product safety evaluation project depends on many factors, such as, status of the product design at the beginning of the evaluation, available documentation, how rapidly the manufacturer can respond to design issues and speed of the NRTL, NB or other organizations involved.

As an example, evaluation, testing and certification of a typical Information Technology Equipment (ITE) product by organizations such as UL and TÜV, could take three to ten weeks, assuming the product does not have any serious design or documentation issues.

At the completion of a Cost Estimate, an estimate of the project time frame can be provided.

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