From: "Victor L. Boersma" <[email protected]> Ergo, if BABT insists on an IEC-9002 Registered system, it is going beyon= d what the Directive asks for. You should shop around and see whether you can find = a more accomodating Notified Body to fulfil your obligations under the TTE.
The TTE Directive is dying anyway, to be replaced by the CTE Driective th= at no longer requires 3rd Party certification, or compliance with harmonized standards= =2E In the interim, under the terms of the EU-US MRA, the Member States will recognize ISO-9002 Registrations provided by US Registrars. Vic, Article 9 of the TTE Directive states: 1. According to the choice of the manufacturer or his authorized representative established within the Community, terminal equipment shall be subject to either the EC type-examination, as described in Annex I, or to the EC declaration of conformity, as described in Annex IV. 2. An EC type-examination as described in Annex I shall be accompanied by a declaration issued according to the EC dedication of conformity to type procedure as described in Annex II or Annex III. As previously stated, if you choose the Annex IV Route, ie Declaration of Conformity, then you must have an approved quality system (as detailed in Annex IV, point 3.) for production, final product inspection and testing and shall be subject to monitoring by the notified body (as detailed in Annex IV, point 4.) If you choose the Annex 1 Route ie Type Examination this must be accompanied by the issuing of a Declaration of Conformity to Type, based on Annex II or Annex III. Annex III requires that the manufacturer must also operate an approved quality system (as detailed in Annex III, point 3.) for production, final product inspection and testing and shall be subject to monitoring by the notified body (as detailed in Annex III, point 4). Annex II, point 2. states "The manufacturer shall take all measures necessary to ensure that the manufacturing process assures compliance of the manufactured products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them." Continued compliance is monitored by the procedure detailed in Annex II, point 4. "A notified body chosen by the manufacturer shall carry out, or have carried out, product checks at random intervals. An adequate sample of the final products, which may be taken on site by the notified body or on its behalf, shall be examined and appropriate tests shall be carried out to check the conformity of roducts with the relevant requirements of the Directive. In those cases where one or more of the products hecked do not conform, the notified body shall take appropriate measures." The Annex II route is often chosen by a manufacturer intending to supply a limited number of a particular product and is not ready to undergo a full PQA audit, giving a quicker time to market. However PQA is the preferred route for high volume production, or a multiple product manufacturer. Finally, the Type Examination Certificate can be issued by any Notified Body, but the Administrative Approval must be granted by the notified body responsible for your production quality, be it under Annex II, III or IV. Once the MRA is fully operational, ISO 9002 registrations will be recognised by EU Member States, but this is a way off. Meanwhile there is an organisation operating in the US, whose ISO 9002/EN 9002 certificates are accepted by BABT as the basis for issuing Annex III certificates. I hope this is useful, if a little long. Andrea Andrea Bishop TUV Product Service Segensworth Road Titchfield, Fareham, PO15 5RH UK Tel: +(0)1329 443486 Fax: +(0)1329 443470 email: [email protected]
