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Conformity Assessment

The Process

The following information is intended to provide a general understanding of what is involved when working with a Nationally Recognized Testing Laboratory (NRTL), a European Notified Body (NB) or other 3rd party safety organization for conformity assessment of a product. Described are activities that make up the typical evaluation process. Further project activities will depend on desired certification, intended market, complexity of product, and other factors.

1) First Contact:

A good way to start is to look for the safety organization's web page. Many web pages have a contact button that will allow you to send an email to the sales or marketing group. Simply explain that you have a product that you wish to have evaluated and give them your contact information. Or, find a phone number on the web page and call the organization directly and ask to talk with a sales person or an engineer about having a product evaluated. They will be more than happy to talk with you.

2) Cost Estimate:

Soon after a product manufacturer contacts a safety organization to discuss the evaluation of their product, the question of costs will need to be addressed. Before a cost estimate (or quote) can be obtained certain information will need to be provided by the product manufacturer. Preferably a sample of the product or at a minimum, conceptual drawings, schematics and other support documentation will be needed. Without this information the cost estimate can only be considered budgetary and costs will normally be guesstimated toward the high end.

During the process of generating a cost estimate, many aspects of the product should be discussed with the manufacturer. Some of these are:

Identifying the type of product in terms of ITE, Test and Measurement, Machinery, Medical, Appliance, etc., or some combination. This will determine the applicable safety standard(s).

Product hazards should be identified, such as electrical, mechanical, fire, chemical, ionizing and non-ionizing radiation, etc. The hazards associated with the product will influence which standards and tests apply.

Target markets for consumer or industries and different countries. The intended markets will help determine the type of certification desired, regulatory requirements and additional costs.

The product manufacturer's production schedule should be reviewed and the factory location should be identified.

Obvious major design issues should be brought to the attention of the manufacturer. Based on time and available information, activities 4 and 5 below should be considered in order to provide a more accurate costs estimate.

Product evaluation costs can be greatly affected by the selection of components, materials, and the product manufacturer's experience in designing a product to meet the required safety standard(s).

3) Purchase Order:

Normally NRTLs, NBs and other 3rd party safety organizations will not start a project until a purchase order is received. Some organizations may require a partial or full deposit before starting the project. Failure of the product manufacturer to address these activities in a timely manner will delay completion of the evaluation process.

4) Product Evaluation and Report:

The product evaluation can begin as soon as a standard(s) is identified and a sample or adequate design information is available. The evaluation continues through testing and concludes when all support documentation has been reviewed and the necessary report(s) are completed. The normal intent is to acquire a positive evaluation for certification from a NRTL, NB or for supporting CE Marking requirements.

During the evaluation the product design will be reviewed to identify if hazards and other requirements have been addressed based on the standard(s) requirements. Safety critical components will be identified and listed in the report. Should the product design need to be modified, additional costs may be incurred.

5) Test Plan.

Based on the applied standard(s) a test plan will be developed that will identify the specific safety tests to be conducted on the product and possibly on components as well. This process may uncover additional costs if unanticipated tests are required.

6) Testing.

Where the testing takes place will depend on the desired certification and resources needed for testing. In some situations testing can be done at the manufacturers facility. The majority of testing is done at a NRTL or NB test lab, or other independent 3rd party test lab.

If certification from a NRTL or NB is desired, performing some preliminary test to confirm compliance may be desirable to avoid failure and to save time and money when official testing is performed.

Not all, but some tests can be destructive. This will drive the need for multiple samples or the manufacturer will need to be available during testing and prepared to repair damages so that testing can proceed.

7) Documentation.

The product manufacturer must provide documentation that describes the product and shows that components and materials meet appropriate requirements. Types of documents needed would be; electrical and mechanical drawings, operator and service manuals, component data sheets and certificates or licenses showing components comply with appropriate standards. The safety organization will review documents to verify the correct supporting information is provided.

The safety organization will generate the needed documentation to support the findings of the product evaluation. Normally this is in the form of a report based on the standard(s) applied. Reports are usually available to the product manufacturer, but in some cases at an additional cost.

When a safety organization Mark is placed on a product the manufacturer will be responsible to maintain records and inform the safety organization of any design changes involving safety critical components or that affects the safe use of the product.

If the manufacture intends on shipping products into the European Union then for most products, documentation requirements for CE marking must be followed. This will involve documenting how the product satisfies regulator requirements by creating a Technical File and creating a Declaration of Conformity.

See Documentation Requirements for more information on this activity.

8) Factory Inspection

When obtaining a certification Mark from a NRTL or NB, periodic factory inspection will be required.

If a factory is not already under the appropriate inspection program, then before the Mark can be applied to the product a factory inspection will be required. Depending on the safety organization and type of certification, factory inspections are typically conducted once, twice or four times a year.

Costs for a factory inspection can range from a few hundred dollars to over $1K, plus expenses. These cost are not always included with the product evaluation cost estimate.

Inspections can consist of verification that approved safety critical components are being used, safety tests are being performed in production, and the manufacturer is applying an adequate quality program for production of a consistent product.

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Page updated on November 20, 2009