Need help achieving ATEX QAN approval or preparing for an IECEx QAR assessment? QHSE Aberdeen provides specialist consultancy, gap analysis, management system implementation and internal audit support for manufacturers of explosion-protected equipment.

Manufacturing equipment for use in hazardous areas requires more than an ISO 9001 certificate. Manufacturers must demonstrate that their production processes consistently deliver equipment that conforms to its certified design.

Whether you manufacture intrinsically safe (Ex i) equipment, electrical or non-electrical Ex products, or equipment intended for Zone 0, Zone 1 or Zone 2 hazardous areas, understanding the applicable ATEX and IECEx quality assurance requirements is essential.

At QHSE Aberdeen, we help manufacturers throughout the UK and internationally develop, implement and audit quality management systems against ISO/IEC 80079-34, supporting readiness for QAN and QAR assessments.

What Is a QAN (Quality Assurance Notification)?

A Quality Assurance Notification (QAN) is associated with the manufacturer’s approved quality assurance system under the ATEX Directive 2014/34/EU.

For conformity assessment routes requiring quality system approval, an ATEX Notified Body assesses the manufacturer’s ability to maintain consistent production of equipment that meets its certified design.

This may involve ATEX Annex IV (Module D – Production Quality Assurance) or Annex VII (Module E – Product Quality Assurance), depending on the applicable conformity assessment route.

QHSE Aberdeen supports manufacturers with QAN gap analysis, ISO/IEC 80079-34 implementation, internal auditing, documentation and preparation for Notified Body assessment.

What Is a QAR (Quality Assessment Report)?

A Quality Assessment Report (QAR) is issued by an IECEx Certification Body (ExCB) following assessment of a manufacturer’s quality management system.

It demonstrates that the relevant manufacturing location has been assessed for its ability to consistently produce Ex equipment in accordance with the certified design.

QARs form an important part of the IECEx Certified Equipment Scheme, alongside the relevant Ex Test Report (ExTR) and IECEx Certificate of Conformity (CoC).

QHSE Aberdeen provides IECEx QAR assessment preparation, quality management system development and ongoing audit support.

ISO/IEC 80079-34 – Why Does It Matter?

ISO/IEC 80079-34 establishes specific quality management requirements for manufacturers of explosion-protected equipment.

Although ISO 9001:2015 provides a strong foundation, manufacturers must also address Ex-specific requirements, including certified design control, component traceability, supplier management, production verification, inspection, testing, competence and change control.

Our consultants can help integrate ISO/IEC 80079-34 requirements into an existing ISO 9001 Quality Management System, reducing unnecessary duplication while strengthening manufacturing assurance.

How Can QHSE Aberdeen Help You Prepare for QAN/QAR Approval?

We provide a structured consultancy service tailored to the manufacturer’s products, existing systems and certification requirements.

ISO/IEC 80079-34 Gap Analysis

A detailed assessment of your existing quality management arrangements to identify the additional controls and evidence required for Ex equipment manufacture.

QAN/QAR Management System Implementation

Development and implementation of practical processes and documentation aligned with ISO/IEC 80079-34 and the relevant certification scope.

ISO 9001 and ISO/IEC 80079-34 Integration

Integration of Ex manufacturing quality assurance requirements into an existing ISO 9001 system, helping avoid unnecessary duplication.

QAN/QAR Internal Audits and Pre-assessment Reviews

Independent auditing and readiness reviews to identify weaknesses before assessment by the relevant Notified Body or IECEx Certification Body.

Corrective Action and Surveillance Audit Support

Assistance with addressing assessment findings, improving manufacturing controls and preparing for ongoing surveillance and reassessment.

Support for Intrinsically Safe and Zone 0 Equipment Manufacturers

We can support manufacturers of intrinsically safe (Ex i) equipment, including products intended for hazardous areas classified as Zone 0, where the applicable product protection level and certification requirements are particularly demanding.

For Zone 0 gas applications, equipment generally requires ATEX Category 1G and Equipment Protection Level Ga.

It is important to distinguish between product certification and manufacturing quality assurance. QAN/QAR assessments concern the manufacturing quality system; they do not independently certify a product for Zone 0 use.

Why Choose QHSE Aberdeen?

QHSE Aberdeen combines established ISO management system consultancy expertise with practical experience of specialist Ex manufacturing quality assurance requirements.

Our approach focuses on:

• Practical, auditable management systems.
• Integration with existing ISO 9001 arrangements.
• Support tailored to manufacturing operations.
• Clear project planning and delivery.
• Experienced internal auditing and compliance support.
• Consultancy services for UK and international manufacturers.

We understand the commercial pressures manufacturers face when preparing for certification, particularly where new products, demanding delivery schedules and technical compliance requirements must be managed simultaneously.

Our aim is to help you establish effective, sustainable quality controls and approach your QAN/QAR assessment with confidence.

Frequently Asked Questions

Do I need ISO 9001 certification before applying for QAN or QAR?

An existing ISO 9001 system can provide a useful foundation, but ISO 9001 certification alone does not demonstrate compliance with all ISO/IEC 80079-34 requirements. The precise certification prerequisites should be confirmed with the relevant assessment body.

Can QHSE Aberdeen help us achieve QAN/QAR approval?

Yes. We provide consultancy, gap analysis, management system development, implementation, internal audits and assessment preparation. Formal QAN approval and IECEx QAR issuance remain the responsibility of the authorised bodies.

How long does QAN/QAR preparation take?

This depends on the maturity of your existing management system, manufacturing complexity, product certification scope and the gaps identified. We can assess your current position and develop a realistic implementation programme.

Can we integrate ISO/IEC 80079-34 with ISO 9001?

Yes. For many manufacturers, integrating the additional Ex-specific requirements into an existing ISO 9001 system is an efficient and practical approach.

Can you support manufacturers outside the UK?

Yes. QHSE Aberdeen supports organisations in the UK and internationally, with the delivery approach agreed according to project requirements.

Can you help with ATEX and IECEx audits?

We can support manufacturing quality assurance audits, ISO/IEC 80079-34 internal audits, QAN/QAR gap assessments and preparation for independent certification-body assessments.

Need an ISO/IEC 80079-34 Consultant or QAN/QAR Audit Support?

Whether you are preparing for your first QAN or QAR assessment, integrating ISO/IEC 80079-34 into an existing ISO 9001 system or seeking specialist support with Ex manufacturing compliance, QHSE Aberdeen can help.

Contact QHSE Aberdeen to discuss your ATEX, IECEx and QAN/QAR requirements.

QHSE Aberdeen is an independent consultancy and does not issue ATEX product certificates, QAN approvals or IECEx QARs.