Source: http://www.industry-finder.com/machinery-directive/guide-application-atex-2014-34-ue-directive-annex-vii-module-e-conformity-type.html
Timestamp: 2017-05-23 06:54:01
Document Index: 190828859

Matched Legal Cases: ['§ 208', '§ 209', '§ 210', '§ 211', '§ 212', '§ 213', '§ 214', '§ 215']

Guide to application of the ATEX 2014/34/UE directive - ANNEX VII MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE | ATEX directive - Machinery 2006/42/CE directive & functional safety
Guide to application of the ATEX 2014/34/UE directive - ANNEX VII MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE Submitted by root on Tue, 02/28/2017 - 06:45 ANNEX VII
§ 208 Conformity to type based on product quality assurance
Module E “Conformity to type based on product quality assurance” as Annex VII to the ATEX Directive 2014/34/EU (indicated as “Product quality assurance” in the previous Directive 94/9/EC) is one of modules that may be applied after the Module B (EU-type examination certificate, Annex III).
This conformity assessment procedure is based on a quality system approved by a notified body for the final inspection and testing of equipment subject to on-going surveillance.
§ 209 Manufacturing
The manufacturer has to implement and manage an approved quality system for final product inspection and testing of his products, in order to ensure compliance of the manufactured products to the approved EU-type (under module B) and the legislative requirements.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(e) in order to verify the manufacturer's ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
§ 210 Quality system
The quality system must include the following elements, to be documented:
- tests (carried out after the manufacturing),
Tests carried out before or during the manufacturing, as well as manufacturing techniques, are not part of the quality system under module E (as it is the case for modules D), because module E targets the final product quality and not the quality of the whole production process (as it is the case for module D).
§ 211 Surveillance under the responsibility of the notified body
The notified body performs periodic audits in order to assess and survey the quality system. Audits include:
§ 212 CE marking, EU declaration of conformity and attestation of conformity
As in this conformity assessment module (E) the notified body is involved in the production phase, the CE marking must be followed by the identification number of the notified body.
§ 213 Obligations for the manufacturer
§ 214 Obligations for the notified body
§ 215 Authorised representative