Given the onerous nature of an explosion, special certification schemes have been set up to control the design and certification of equipment for use in potentially explosive atmospheres.  Although the schemes differ globally (some are mandatory under law, some are simply procurement specifications), the bases for design and certification is similar, and the schemes normally rely on empirical testing, constructional assessment and ‘production control’ by a recognised Certification Body.

The production control (quality management) part of certification is known as a Quality Assurance Notification (ATEX and UKCA) or Quality Assurance Registration (IECEx) and the Standard that is applied is EN ISO IEC 80079-34. The Quality Module/Registration 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 Quality Module/Registration is 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.

Quality Module/Registration audits are normally conducted by an auditor with experience of both Quality Systems and Hazardous Area products. Unlike an ISO audit, where the worst-case scenario is losing your ISO accreditation, non-compliances in a Quality Module/Registration could lead to your products being recalled from the market!

These requirements require an internal person (normally referred  to as the ‘Authorized Person’ to have significant knowledge of EN ISO IEC 80079-34 and the protection concepts used for manufacturing. An example of the types of things the Ex Quality System would need to address are given below:

• On receipt of an EX sales enquiry, how do you ensure that what the customer requests is covered by your certificate? (gas groups, zone, temperature class, etc.)
• How would you indicate and control an EX build from the design plan?
• Controls in place to 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 Body.
• How would procurement be controlled to ensure suitably rated EX parts and/or materials are sourced and verified ?
• Are EX parts inspected prior to installing them by someone with appropriate competence ?
• How do you know what other special features are required for an EX build
• Is everyone who works on an EX unit specially trained on Ex equipment Installation and Inspection.
• Were all materials such as potting/encapsulation within ‘use by’ dates?
• Does the final inspection and test plan cover the EX routine tests and requirements?
• 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.
• Considered Standards listed on your CE/UKCA Declaration of Conformity within your Quality System as controlled documents. You should have a mechanism for knowing when these standards change or are withdrawn and take the appropriate action.
• Have an ‘EX Authorized Person’ listed in your ATEX Quality Module System, this person is normally technical and well trained in ATEX, and  is the ‘go to’ person for interpreting the schedule drawings, working with the Notified Body and periodically reviewing the Standards.

ExVeritas issue ATEX and UKCA QANs, IECEx QARS, UKAS ISO9001 and other global quality approvals such as INMETO and CCC audits. ExVeritas also offer ‘Ex Authorized Person’ training for both internal and external auditors. Please view our training for more details. www.exveritas.com