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Information Sheets

EC Declaration of Conformity – QA System Implications

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Introduction

A number of matters relating to the ATEX Directive combine to give rise to QA System implications regarding EC Declarations of Conformity, or the equivalent document for components, the Written Attestation of Conformity.  

The Declaration should contain certain information showing how the requirements of the Directive are met, and this information may change as time progresses. This is described in the ATEX Guidelines – Section 10 (linked from the Baseefa website at www.baseefa.com/page100.asp ). 

In particular, it should show how products comply with the latest applicable technical knowledge, by reference to Harmonised Standards which allow a presumption of conformity, or other Standards, separately listed. 

Also of course, there is the need to send a current copy of the Declaration with each product or batch of products delivered, and maintain records of previous versions.
 

Questions to ask -

  • The Declaration should be signed by an appropriate official within the company. Is this authority defined?
  • Is the responsibility for keeping up to date with latest technical developments defined? This may include responsibility for the technical validity of the Declaration (which could be different to the person who signs the document), and should involve any necessary review and dissemination of information obtained.
  • For persons responsible for keeping up to date with latest technical developments, is there an appropriate record of their qualification or of relevant training?     
  • For such persons, are there appropriate means of keeping up to date? This may be achieved in a number of ways. For instance, involvement in Standard making activities is an ideal if not common one. Procedures for keeping up to date when Standards are revised may be important, but this gives little warning of change. More relevant may be receiving information from Notified Bodies or monitoring of the Baseefa website www.baseefa.com under Harmonisation Status.
  • Are EC Declarations included in document control procedures? This may provide an answer to earlier questions, and should deal with the issue of recording changes. Please note that the Declaration relates to each individual product on the day it is delivered, so, unlike most documents, may need to be re-authorised if a responsible person no longer remains so (e.g. leaves the company or assumes an entirely different role).
  • Does the process for despatch of product provide for a copy being sent with each one, or batch if appropriate?  Please note that there has now been a Notified Body agreement that posting the document on your company website is not sufficient in itself, a copy must accompany the product.
  • Are Declarations accurate and up to date, and do they contain the necessary information? e.g.: 

Are Standards listed as Harmonised Standards still harmonised (a current table is maintained on the Baseefa website www.baseefa.comHarmonisation Status).  The formal list of harmonised standards is available from the EU
Commission website. This can be accessed through the Links section on the Baseefa website. 

Are Harmonised and non-Harmonised Standards listed separately? 

Is the correct ATEX coding included?

Is the correct Notified Body and Type Examination Certificate information included?

Is the document signed by the correct person?
           

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