ATEX & IECEx Quality Assurance

ATEX & IECEx Quality Module Certification

ExVeritas is one of only around 25 in the world that can issue both ATEX Notified Body and IECEx QANs and QAR’s in a combined audit.

ATEX Quality Module Audits (QAN)

EQuality Modulexveritas conduct manufacturing audits (as an ATEX Notified Body)  that can lead to ATEX Quality Module Certification being issued if the findings are satisfactory. ATEX Quality Modules are required for CAT 1 equipment and Category 2 electrical equipment. Once you have obtained the appropriate Quality Module for the type of equipment and protection concepts used, you will be able to manufacture ATEX equipment and use our Notified Body Number (2585) under your CE Mark to show that your Quality System is under the control of a Notified Body for the ATEX Directive.

IECEx Quality Assurance Registration (QAR)

Exveritas conduct manufacturing audits (as an IECEx Certification  Body)  that can lead to IECEx Quality Assurance Registration being issued if the findings are satisfactory.  IECEx Quality Assurance Registration is required for all IECEx Product Certification other than Unit Verification.

Save time and money by having your ATEX and IECEx Audits done at the same time by ExVeritas

Complete an on-line quote application form to get an ATEX, IECEx or combined audit for Ex Equipment Manufacture.

Example Quality Module Requirements

The ATEX Quality Module and IECEx Quality Assurance Registration can be considered as an ‘Add on’ to a typical ISO 9001:2000 quality system. It requires ‘EX’ 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. To get you started, here are a few of the more important aspects you will need to consider.

  1. On an EX 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.)
  2. How would you indicate and control an EX build from the design plan?
  3. The EX 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.
  4. How would procurement be controlled to ensure suitably rated EX parts and/or materials are procured?
  5. Are EX parts inspected prior to installing them by someone with appropriate skills?
  6. How do you know what other special features are required for an EX build (i.e. two fans)?
  7. Is everyone who works on an EX 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)
  8. Does the final inspection and test plan cover the EX routine tests and requirements? Ensure that the certification label is not fitted until the final sign off has been achieved.
  9. Record all routine tests with signatures/tractability. Ensure all equipment is calibrated.
  10. Ensure you have a record of where each EX certified unit is delivered in case there needs to be a re-call.
  11. Cover EX on agendas for management meetings (to discuss related issues) and in your audit schedule.
  12. If you have an EX  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+)
  13. Have an ‘EX Responsible Person’ listed in your EX Quality Module , this person is normally technical and well trained in EX, it is the ‘go to’ person for interpreting the schedule drawings, working with the Notified Body and periodically reviewing the Standards.

If you have any question  on ATEX Quality Systems or CE Management please contact us