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For the conformity assessment procedure which is to be performed by the manufacturer, the Directive 94/9/EC claims the fulfillment of in each case two appendices of the Directive. In addition to the module EC-TYPE EXAMINATION according to Annex III the module PRODUCTION QUALITY ASSURANCE according to Annex IV has to be applied in most cases for equipment of equipment category 1. For equipment of equipment category 2 the Directive provides for the combination with module PRODUCT QUALITY ASSURANCE according to Annex VII.

Annex IV and Annex VII of the Directive claim the supervision of the quality assuring measures under the responsibility of a notified body. The inspection of the production sites by the notified body is absolutely necessary. This so-called Ex-audit is based on a valid QM-system certificate. An Ex-audit requires an approved QM-system in accordance with DIN EN ISO 9001:2000.

The European Standard EN 13980:2002 stipulates special requirements and information regarding the introduction and maintenance of a QM-system which complies with the requirements of Annex IV and VII of the Directive 94/9/EC.

For the purpose of a consistent implementation of Annex IV and Annex VII ZS-Ex of PTB observes the recommendations of the “Guidelines of the Management of Assessment and Surveillance Programs for Product covered by Annex IV and VII of the ATEX Directive 94/9/EC“  of the ATEX Notified Body Group (ExNB).

In the meantime PTB is well experienced with the evaluation of Ex-manufacturer's quality assurance systems. Numerous well skilled auditors are available. We will support you with our advice even in the forefront of an audit.

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