Quality Assurance Requirements in the Certification Process

Mastering Quality Assurance with Our Expert Certification Guidance

Every electrical products for use in hazardous locations must be tested as part of the certification process to ensure that it complies with relevant Standards. The manufacturer must also have a quality assurance process in place, which ensures that the Standards can be maintained consistently and completely during production on an ongoing basis. Any and all sites at which the product is manufactured must be audited. Documented product designs and records are reviewed, Tests carried out must be verified.
This is especially true for ATEX and IECEx certifications. Following are the requirements related to quality assurance for each of these certifications.

ATEX Quality Assurance Requirements

The ATEX certification process includes compliance by equipment manufacturers with the specific quality assurance requirements of ATEX. Compliance with these requirements, which results in a “Quality Assurance Notification” (QAN), is mandatory for both Category 1 and Category 2 electrical products. QAN involves the initial and ongoing monitoring of manufacturing  systems and processes to ensure compliance with EN 80079-34, as well as with the appropriate Annex(es) of the ATEX Directive (IV, V, VI, VII or IX) .  Various annexes apply, based on the Zone, mass or fixed number of products manufactured, and the existence (or not) of ISO certification. Given a valid ISO 9001 certificate for a product, a manufacturer might expect the QAN process to be simpler because many of the basic requirements of  ISO 9001 and EN 80079-34 overlap.

Following are the related Directives, schemes and Standards which must be met for an ATEX Quality Assurance Notification:

  • ATEX Directive – 2014/34/EU (which replaces the original ATEX Directive 2014/34/EU)
  • ISO 80079-34 - Explosive atmospheres – Part 34: Application of quality systems for equipment manufacture
  • ISO 9001 - Quality management systems

IECEx Quality Assurance Requirements

Similar to ATEX, IECEx requires that manufacturers of equipment for which they are seeking IECEx certification have a compliant, documented quality assurance process and system in place for their products in order to achieve Ex certification. Compliance with the IECEx quality assurance requirements  results in a “Quality Assurance Report” (QAR), which is mandatory. Again, QAR involves the initial and ongoing monitoring  of manufacturing  systems and processes to prove compliance.

Following are the related Directives, schemes and Standards which must be met for an IECEx Quality Assurance Report (QAR):

  • IECEx – The IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres
  • ISO 80079-34 - Explosive atmospheres – Part 34: Application of quality systems for equipment manufacture
  • ISO 9001 - Quality management systems

In order to comply with standard IEC 80079-34, the organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. These persons are called Ex authorized person(s). In accordance with clause 5.3 of standard IEC 80079-34:2018, the manufacturers must appoint Ex- authorized person(s) with defined and documented responsibilities and authority.

The manufacturer shall have a documented process to identify and ensure that Ex-authorized person(s) that having an impact on the compliance of Ex Products are trained and competent.

How Hazcon Can Help

Members of the Hazcon team can act as trained and competent Ex-authorized persons to work with your team to get IECEx/QAR and ATEX/ QAN certifications for your Ex-products and become a part of your quality assurance team.

In order to comply with ISO 80079-34, Hazcon will:

  • effectively co-ordinate activities with respect to Ex products
  • liaise with the issuer of the certificate with respect to any proposed change to the design defined in the certificate and the technical documentation
  • liaise with the body responsible for the verification of the quality management system with respect to any planned updating of the quality management system
  • authorize initial approval and changes to related drawings, where appropriate
  • verify the accuracy of relevant information regarding Ex products given to the customer for any sales literature and installation instructions (which shall include applicable Specific Conditions of Use and any Schedule of Limitations)
  • effectively coordinate manufacturing processes related to Ex Products including externally provided products, services, and processes

We will help you achieve and maintain compliance with QAR/QAN requirements in order to place and keep your Ex products in the marketplace.

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