ATEX Quality System Requirements

ATEX Quality System Requirements

ATEX Quality System Requirements

The ATEX Directive is a mandatory European Directive for manufacturers of equipment for potentially explosive atmospheres. In addition to 'product certification' through a Notified Body (for Category 1 & 2 electrical and 1 non-electrical), a manufacturer must also have a certified 'Quality System'. This certification is known as a 'Quality Module' and again must be issued by an ATEX Notified Body. The Quality Module permits the manufacture of equipment that holds a type examination certificate where the concept of the certification (for example Flameproof, Ex d) is covered by the quality assessment and certificate.

The ATEX Quality Module is generally considered an Add on' to ISO9001. It requires ATEX to be addressed or considered in each applicable clause of the Standard of ISO9001 or that a 'Quality Plan' be created that also adequately addresses the requirements. This article outlines in simple terms the basic requirements for adding ATEX product manufacture to your Quality System.

The basic intent of the ATEX Quality Module (there is of course a lot more detail) is outlined below.

On an ATEX sales enquire, how do you ensure that what the customer requests is covered by your certificate? (Consider the build, gas groups, zone, temperature class, ambient temperature etc.)

How would you indicate and control an ATEX build from the design plan?

Ensure all units are built to within the scope of the schedule' drawings (the drawings listed on the certificate). Ensure these drawings remain unchanged, if a change is required apply for a variation' through the issuing Notified Body as a new certificate will need to be issued with the new revision number. Record the fact that the build is covered by the schedule drawings.

How would procurement be controlled to ensure suitably rated ATEX parts and/or materials are procured?

Are ATEX parts inspected prior to installing them by someone with appropriate skills?

How do you know what other special features are required for an ATEX build (i.e. two fans)?

Is everyone who works on an ATEX unit specially trained on Ex equipment Installation and Inspection. How is this recorded and how often do they receive refresher training (should be within 5 years of initial training)

Does the final inspection and test plan cover the ATEX routine tests and requirements? Ensure that the certification label is not fitted until the final sign off has been achieved.

Record all routine tests with signatures/tractability. Ensure all equipment calibrated.

Ensure you have a record of where each ATEX certified unit is delivered in case there needs to be a re-call.

Cover ATEX on agendas for management meetings (to discuss related issues) and in your audit schedule.

You should have all the Standards listed on your CE Declaration of Conformity within your Quality System as controlled documents. You should have a mechanism for knowing when these standards change or are withdrawn (for example, automatic updates from BSI+)

Have an ATEX Responsible Person' listed in your QM, this person is normally technical and well trained in ATEX, it is the go to' person for interpreting the schedule drawings, working with the Notified Body and periodically reviewing the Standards.

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