IECEx and ATEX production quality systems
Production quality system compliance is in most cases a mandatory aspect of an IECEx or ATEX product certification. The purpose is to ensure by means of audits at the manufacturing site(s) that all manufactured products are in compliance with the same construction requirements and technical specifications as the product that was originally evaluated and tested for the product certificate.
These audits are based on the production quality requirements stated in standard EN ISO/IEC 80079-34, which is based on ISO 9001 requirements plus additional quality requirements related to explosion safety.
Manufacturers not having an ISO 9001 certification for their production, will be audited against both standards ISO 9001 and EN IEC/ISO 80079-34.
For IECEx a product certificate is directly linked to the IECEx Quality Assurance Report (QAR) and can only be issued if there is a current QAR.
For ATEX a product certificate is not linked to the Production Quality Assurance Notification (PQAN) and thus the product certificate can be issued without having the PQAN completed. But if a production quality certificate is mandatory by the ATEX Directive, the manufacturer may not put his product on the EU market before he has obtained the PQAN.
Since the requirements for a QAR and PQAN are very similar, being based on the same standard, it is relatively simple to include both in one manufacturing audit.
For more details on production quality requirements, please contact us.