|
|
NIST SP 951
Self-CertificationMost products covered by New Approach Directives can be self-certified by the manufacturer and do not require the intervention of a Notified Body. To self-certify, the manufacturer must assess the conformity of products to the applicable directives, and to the standards if applied. The manufacturer may affix the CE marking to products or equipment (and prepare and sign the Declaration of Conformity) as long as he or she can prove conformity to the applicable requirements. Proof is provided in the Technical File that the manufacturer must compile. Certain (high risk) products may not be self-certified, but must be subjected to an EC type-examination. This examination involves the inspection of a representative example by a Notified Body. Notified BodiesMost products within the scope of European product legislation (New Approach Directives) can be self-certified by the manufacturer and do not require the intervention of a Notified Body. There are products, however, which may not be self-certified, but must be subjected to an EC type-examination. This examination involves the inspection of a representative example by a Notified Body within the EEA. Notified Bodies are independent testing houses, laboratories, or product certifiers authorized by the EU Member States to perform the conformity assessment tasks specified in directives. A Notified Body is appointed by a Member State and must have the necessary qualifications to meet the testing and/or certification requirements set forth in a directive. A Notified Body not only needs to be technically competent and capable of carrying out the specified conformity assessment procedures, but it must also demonstrate independence, impartiality, and integrity (The EN 45000 standard series addresses criteria for accreditation, assessment, and operation of conformity assessment bodies, i.e., Notified Bodies). Notified Bodies may carry out their activities in one or more Member States or in countries outside the EEA. A Notified Body may also use a subcontractor to perform part(s) of a conformity assessment procedure. Many U.S. testing houses, for example, act as subcontractors to Notified Bodies. The Notified Body, however, is the ultimate authority, is always responsible, and is the sole source of the certificate claiming compliance. Return to the Table of Contents
|
Previous Page