Principle of QAN (Quality Assurance Notification) Certification According to ISO/IEC 80079-34

Quality Assurance Notification (QAN) is awarded to Ex products manufacturers who have established, documented and implemented a quality management system and demonstrated its compliance to EN ISO/IEC 80079-34:2018 during onsite audit. Like EU-type examination certificate, it is a mandatory requirement for ATEX equipment manufacturers to have a Quality Assurance Notification for Category 1 and Category 2 products. The Quality Assurance Notification is the continued monitoring of systems and processes in relation to those products in accordance with EN 80079-34.

We at QVC through it’s alliance partners, provide ATEX Quality Assurance Notifications and IECEx Quality Audit Reports (QAR) through our team of competent, qualified auditors, having vast industrial experience.. All have got hands on experience in auditing Quality Management System for Ex products at multiple locations across the globe.

The objective of audit is to confirm that the quality system, manufacturing and support processes are established, documented, communicated, implemented and maintained effectively and possess the capability to produce Ex products conforming to laid down standard for relevant protection concept.

EN ISO / IEC 80079-34:2018 includes:

  • electrical equipment (IEC 60079-0, -1, -2, -5, -6, -7, -11, -13, -15, -18, -28, – 33)

  • non-electrical equipment (ISO 80079-36 and -37)

  • protective systems (ISO 16852)

  • safety devices (IEC 60079-29)

  • Ex Components (IEC 60079-0, …)

  • and their combinations as assembly of Ex equipment (IEC 60079-46)

Information on timelines for transition to new version

  • The new version EN ISO/IEC 80079-34:2018 was published on August 30th, 2018
  • ISO/IEC 80079-34:2018 cancels and replaces the first edition, published in 2011, and constitutes a full technical revision
  • The transition period to new version- until August 2020.

Crucial elements of the standard

  • Adopted High Level Structure .i.e. clause wise structure to align it with ISO 9001:2015

  • Emphasis on having documented process to ensure competence of persons having impact on compliance of Ex products

  • Control on internal –external communication relating to Ex products

  • Due to the alignment with ISO 9001:2015, emphasis on more systematic documentation

Benefits of Certification

  • Integration of quality system for Ex products with other quality management systems like ISO 9001:2015, IATF16949, ISO 29001 etc.

  • Facilitating the process of demonstrating compliance with the requirements of ATEX Directive, IECEX  and corresponding government regulations

  • More stabile production process for Ex products

  • Enhanced capability to monitor and control quality of Ex products

  • Demonstration of effectiveness and efficiency of the built quality management system by independent Certification Body

  • Conducive to ensure compliance to worldwide regulations related to Ex products .i.e. like ATEX and IECEX

  • More help to comply to different Ex standards related to various protection concepts using Annex provided

  • Improving the company”s profile/image

  • More guarantees for meeting legal and other requirements

  • Competitive advantages

Certification Process

The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Implementation of System Documentation
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice depends upon the client organization.

The certification audit takes places in two stages.

1st stage audit

  • Registration of application for certification
  • Desktop Assessment of System documentation
  • Elaboration of the 1st stage desktop review report and findings

2nd stage audit

  • Agreement for conducting a 2nd stage audit
  • Appointing a team of auditors
  • Verification of the implementation of the gaps identified during stage 1 desktop rerview.
  • Preparing an audit plan
  • On-site audit from the point of view of the environmental aspect
  • Elaboration of the 2nd stage audit report
  • Closure of the non-conformities after verification of corrective actions implemented by the manufacturer.
  • Issuing the certificate

During the three year validity period of the certificate, a surveillance audit will take place within 18 months.  A re-assessment audit in order to renew the ATEX QAN will take place 2-3 months prior to the expiry of the existing certificate.  If the manufacturer does not have an ISO 9001 certificate in place, the surveillance audit needs to be done within 12 months.