Conformity Magazine - April 2008 - (Page 18)

The Notified Body will issue a Quality Assurance Notification when a product complies with the requirements of one of the Annexes IV, V, VI or VII. The production control Annexes are divided into two types, which correspond to equipment categories. Annexes IV and VII are based on established quality assurance principles and use standard EN 13980:2002 in conjunction with the ISO 9001:2000 standard in order to determine compliance. Inspections for these Annexes are generally conducted twice every three years. Annex VI uses similar principles as those applied for U.S. Hazloc inspections, but these inspections are conducted annually. Annex V is a rarely used procedure because it relies upon witnessed tests of every production sample by the Notified Body. Where EN 13980 is used, manufacturers usually need to make minor modifications to their quality system documentation in Requirement order to comply with the specific requirements of the standard. Due to the relative infrequency of inspections when compared to the U.S. Hazloc system, the quality of the ISO 9001 system and the associated internal audit process are particularly important. However, the requirements of EN 13980 have some equivalence to Hazloc requirements (e.g., purchasing documentation and stock control) and hence should not present significant problems to manufacturers who are familiar with the U.S. approach. The IECEx certification system also includes a factory inspection element which is very similar to EN 13980. Applying ATEX Marking The ATEX Product Directive outlines mandatory marking for all ATEX products, which includes the distinctive Ex symbol followed by the group designation, the equipment category and area of use. For example, a II 2 G marking shows suitability for zone 1, gas, surface applications. Explanation a) Name or identification mark and the address of the manufacturer or Note that the name on the product places the named organisation in the his authorised representative in the Community. position of manufacturer (or authorised representative). b) A description of the equipment, etc. A descriptive product designation, For an assembly it should list the items in the assembly that are e.g. Motor Control Unit Type ABC 123, and its intended use. ATEX equipment in their own right, and which have been separately assessed. c) All relevant provisions fulfilled by the equipment, etc. The marking included on the product e.g. II 2 G Ex ib IIC T4. d) Where appropriate, the name, identification number and address Name and number of the notified body (or bodies) conducting the ECof the notified body and the number of the EC-type examination type examination. In the case of category 2 non-electrical equipment, certificate. it should refer to the Notified Body holding the copy of the technical documentation file. Where relevant, if the body responsible for oversight of the QA regime is not the same as the one issuing the original certificate, it should be named separately. However, the name and address of a Notified Body involved in the production phase is not a mandatory requirement. Where the Annex applied for conformity assessment does not require the use of a Notified Body then this section is not appropriate. e) Where appropriate, reference to the harmonized standards. The harmonized standards quoted in the technical documentation file should be listed here. Harmonized standards are those listed in the Official Journal of the European Union. The harmonized status of standards may change over time. When standards are removed from this list (e.g. when they have been withdrawn or superseded) then they cease to be harmonized and should be listed under section (f) of the declaration. Other standards (e.g. non-harmonized) and technical specifications used for confirming compliance with the essential health and safety requirements of the directive (Annex II) and quoted in the technical documentation file should be listed here. Where only harmonised standards have been applied then this section is not appropriate. However, note that the harmonized status of standards may change over time. f) Where appropriate, the standards and technical specifications used. g) Where appropriate, references to other Community Directives which If this is a multi-directive declaration, it should already be clear from the have been applied. heading to which directives the product conforms. h) Identification of the signatory who has been empowered to enter into The signatory needs to be a responsible officer of the manufacturer or commitments on behalf of the manufacturer, etc. of the authorised representative. Table 4: Content of ATEX declaration of conformity 18 Conformity April 2008

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Conformity Magazine - April 2008

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