ATEX Quality Module Requirements
The ATEX Quality Module is an ‘Add on’ to ISO 9001:2000. It requires ATEX to be addressed or considered in each applicable clause of the Standard, If you do not have ISO 9001: 2000, a ‘Quality Plan’ can be used, but the audits are more frequent. EN ISO IEC 80079-34:2011 is the current Standard for ATEX (and IECEx) Quality Control and should be used to develop the necessary control.
ATEX Quality Modules can only be issued by ATEX Notified Bodies such as ExVeritas (NB Number 2585)
To get you started, here are a few of the more important aspects you will need to consider.
- On an ATEX sales enquiry, 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?
- The ATEX Quality Module should 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 is 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.
- If you have an ATEX Quality Module 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 ATEX Quality Module , 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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