ATEX Quality Module Requirements
Any industry that processes, uses or manufactures materials that may give rise to a flammable atmosphere (gas, mist, liquid, dusts or even small fibres) may have a potentially explosive atmosphere. Where fuel and oxygen (normally the oxygen in air) are present in the workplace, potential ignition sources must be rendered safe to an acceptable level for the risk.
Given the onerous nature of an explosion, special certification schemes have been set up to control the design and certification of equipment for 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 part of certification is know as an ATEX Quality Module and the Standard that is applied is EN ISO IEC 80079-34:2011 (This also applies for IECEx Certification where it is called Quality Assurance Registration)
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 ATEX Quality Module and again must be issued by an ATEX Notified Body. The ATEX 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 Quality Module product manufacture to your Quality System (there is far more detail in the Standard)
Quality Module audits are normally carried out by an auditor with experience of both Quality Systems and Hazardous Area products. Unlike an ISO audit, where the worst case scenario is loosing your ISO accreditation, non compliances in an ATEX Quality Module can lead to your products being recalled from the market!
- 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?
- 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.
- You should have all the Standards listed on your CE Declaration of Conformity within your ATEX Quality Module 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 System, 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.
Example of typical ATEX Quality Module requirements for manufacturers of Ex d equipment:
|Example for Flameproof (Exd)|
|Castings: Check and obtain evidence of how verification is conducted including magnesium content, porosity etc.|
|Machining: Check and obtain evidence of how verification is conducted.|
|Cemented joints and potted assemblies: Check and documented procedures, ensure cement stored properly and within use by date.|
|Routine pressure testing: Check and obtain evidence of how verification is conducted. Witness test if possible.Ensure records kept of all tests, ensure personnel conducting tests are competent, ensure equipment (pressure gauge, stopwatch etc.) calibrated)|
|Flange joints: Check and obtain evidence of how verification is conducted.|
If you would like advice on a Quality Module or require an audit, please contact us