What Is an ATEX Quality Assurance Notification (QAN)?
An ATEX Quality Assurance Notification (QAN) is an official document issued by an ATEX Notified Body confirming that a manufacturer's approved quality assurance system satisfies the requirements of Directive 2014/34/EU. A QAN supports conformity assessment procedures based on quality assurance, particularly ATEX Module D (Production Quality Assurance) and ATEX Module E (Product Quality Assurance).
Unlike an EU-Type Examination Certificate, which confirms that a representative product design complies with the ATEX Directive, a QAN confirms that the manufacturer's quality management system is capable of consistently producing equipment that conforms to the approved type.
This article explains what an ATEX Quality Assurance Notification is, why it is required, how it is issued, and how it supports ongoing compliance under Directive 2014/34/EU.
Quick Answer
Quick Answer
An ATEX Quality Assurance Notification (QAN) is a document issued by an ATEX Notified Body after approving a manufacturer's quality assurance system under Module D or Module E of Directive 2014/34/EU. The QAN confirms that the approved quality system is capable of consistently producing explosion-protected equipment that conforms to the product type covered by the EU-Type Examination Certificate.
What Is an ATEX Quality Assurance Notification (QAN)?
A Quality Assurance Notification is formal evidence that an ATEX Notified Body has assessed and approved a manufacturer's quality assurance system for the manufacture of explosion-protected equipment.
The approval is based on an audit of the manufacturer's documented quality procedures, production controls, inspection activities, testing processes, calibration systems, and quality records. The scope of the assessment depends on the conformity assessment module being applied, such as Module D or Module E.
Once approved, the Notified Body issues the QAN to demonstrate that the manufacturer's quality system satisfies the applicable requirements of Directive 2014/34/EU.
Why Is a QAN Required?
Directive 2014/34/EU requires independent oversight for certain conformity assessment routes that rely on quality assurance rather than direct verification of every finished product.
The QAN provides documented evidence that the manufacturer's approved quality system can consistently maintain conformity with the product type previously assessed during the EU-Type Examination.
The QAN helps ensure that:
- Manufacturing processes remain properly controlled.
- Inspection and testing activities are consistently performed.
- Explosion protection characteristics are maintained throughout production.
- Equipment continues to conform to the approved type.
- Ongoing compliance with Directive 2014/34/EU is supported.
Who Issues a QAN?
A Quality Assurance Notification may only be issued by an ATEX Notified Body designated under Directive 2014/34/EU.
Before issuing the notification, the Notified Body performs an audit of the manufacturer's quality assurance system and verifies that it satisfies the applicable requirements of the selected conformity assessment module.
The Notified Body also performs periodic surveillance audits after the QAN has been issued to confirm that the approved quality system continues to operate effectively.
When Is a QAN Used?
A Quality Assurance Notification is primarily associated with conformity assessment procedures based on quality assurance rather than direct product verification.
It is commonly used with:
- ATEX Module D – Production Quality Assurance.
- ATEX Module E – Product Quality Assurance.
Manufacturers using Module C2 or Module F generally follow different conformity assessment procedures and do not rely on a Quality Assurance Notification in the same way as Module D and Module E.
How Is an ATEX Quality Assurance Notification Issued?
Before issuing a Quality Assurance Notification (QAN), an ATEX Notified Body performs a comprehensive assessment of the manufacturer's quality assurance system. The objective is to verify that the system is capable of consistently producing explosion-protected equipment that conforms to the product type approved under the EU-Type Examination.
A typical QAN approval process includes:
- The manufacturer completes the applicable EU-Type Examination under ATEX Module B.
- The manufacturer implements a documented quality assurance system appropriate for Module D or Module E.
- An ATEX Notified Body reviews the quality documentation and performs an on-site audit.
- The quality system is evaluated against the applicable requirements of Directive 2014/34/EU.
- If satisfactory, the Notified Body issues the Quality Assurance Notification.
- The approved quality system becomes subject to periodic surveillance audits.
This process provides independent confirmation that the manufacturer's quality assurance system supports continued conformity of production equipment.
What Does the Notified Body Assess?
During the quality system assessment, the ATEX Notified Body evaluates whether the manufacturer's documented procedures are sufficient to ensure ongoing conformity with the approved product type.
The assessment typically includes:
- Quality management procedures.
- Production and inspection controls.
- Final inspection and testing procedures.
- Calibration of measuring and test equipment.
- Control of nonconforming products.
- Corrective and preventive action procedures.
- Engineering change management.
- Traceability of products and components.
- Personnel training and competency.
- Quality records and document control.
The exact scope depends on whether the manufacturer is applying Module D (Production Quality Assurance) or Module E (Product Quality Assurance).
What Information Does a QAN Contain?
Although the format may vary between Notified Bodies, a Quality Assurance Notification generally includes key information identifying the approved manufacturer and the scope of the quality system approval.
A typical QAN includes:
- QAN reference number.
- Name and address of the manufacturer.
- Name and identification number of the ATEX Notified Body.
- Scope of the approved quality assurance system.
- Applicable conformity assessment module.
- Reference to the relevant EU-Type Examination Certificate.
- Date of issue and validity information.
- Conditions or limitations, where applicable.
The QAN complements the EU-Type Examination Certificate by documenting approval of the manufacturer's quality assurance system rather than the product design itself.
How Is a QAN Maintained?
Issuing a Quality Assurance Notification is not the end of the approval process. Manufacturers must continue operating the approved quality assurance system while the ATEX Notified Body performs ongoing surveillance.
Surveillance activities may include:
- Periodic scheduled audits.
- Additional audits when necessary.
- Review of quality records.
- Evaluation of corrective actions.
- Verification that the approved quality system continues to operate effectively.
If significant nonconformities are identified, the manufacturer may be required to implement corrective actions. Continued failure to maintain compliance may result in suspension or withdrawal of the Quality Assurance Notification.
QAN Compared with an EU-Type Examination Certificate
Although both documents support ATEX conformity assessment, they serve different purposes.
| Quality Assurance Notification (QAN) | EU-Type Examination Certificate |
|---|---|
| Approves the manufacturer's quality assurance system. | Approves the representative product type. |
| Supports Module D or Module E. | Issued following Module B (EU-Type Examination). |
| Focuses on manufacturing quality assurance. | Focuses on technical design compliance. |
| Maintained through surveillance audits. | May require revision if the approved product design changes. |
Together, the EU-Type Examination Certificate and the Quality Assurance Notification provide evidence that both the product design and the manufacturer's quality assurance system satisfy the applicable requirements of Directive 2014/34/EU.
Common Misunderstandings About ATEX Quality Assurance Notifications
A QAN Is the Same as an EU-Type Examination Certificate
No. An EU-Type Examination Certificate confirms that a representative product type complies with the applicable requirements of Directive 2014/34/EU following assessment under Module B. A Quality Assurance Notification (QAN), however, confirms that the manufacturer's quality assurance system has been approved by an ATEX Notified Body under Module D or Module E.
A QAN Certifies the Product
No. A QAN does not certify an individual product. Instead, it confirms that the manufacturer's approved quality assurance system is capable of consistently producing equipment that conforms to the product type covered by the EU-Type Examination Certificate.
A QAN Never Expires
Not exactly. A QAN remains valid only while the approved quality assurance system continues to comply with the applicable requirements of Directive 2014/34/EU and the manufacturer successfully completes the required surveillance audits performed by the ATEX Notified Body.
A QAN Eliminates the Need for Surveillance Audits
No. Ongoing surveillance is an essential part of the quality assurance approval process. The ATEX Notified Body periodically audits the manufacturer's quality system to verify continued compliance and may suspend or withdraw the QAN if significant nonconformities are identified.
Frequently Asked Questions (FAQ)
What is an ATEX Quality Assurance Notification (QAN)?
An ATEX Quality Assurance Notification (QAN) is an official document issued by an ATEX Notified Body confirming that a manufacturer's quality assurance system has been assessed and approved under Module D or Module E of Directive 2014/34/EU.
Who issues a QAN?
Only an ATEX Notified Body designated under Directive 2014/34/EU is authorized to issue a Quality Assurance Notification following a successful assessment of the manufacturer's quality assurance system.
Is a QAN required for every ATEX conformity assessment route?
No. A QAN is primarily associated with conformity assessment procedures based on quality assurance, particularly Module D and Module E. Other conformity assessment routes, such as Module C2 or Module F, follow different verification approaches.
How is a QAN different from an EU-Type Examination Certificate?
An EU-Type Examination Certificate confirms compliance of the product design, whereas a QAN confirms approval of the manufacturer's quality assurance system used to maintain conformity during production.
Can a QAN be suspended or withdrawn?
Yes. If the manufacturer no longer maintains the approved quality assurance system or fails surveillance audits, the ATEX Notified Body may suspend or withdraw the Quality Assurance Notification in accordance with the applicable conformity assessment requirements.
Conclusion
An ATEX Quality Assurance Notification (QAN) provides independent confirmation that a manufacturer's quality assurance system has been assessed and approved by an ATEX Notified Body. Supporting conformity assessment under Module D and Module E, the QAN demonstrates that the approved quality system is capable of consistently producing explosion-protected equipment that conforms to the product type approved during the EU-Type Examination.
Together with the EU-Type Examination Certificate, the QAN forms an important part of the ATEX conformity assessment framework by providing confidence in both product design compliance and ongoing manufacturing quality. Understanding the purpose of each document helps manufacturers, engineers, procurement specialists, and compliance professionals correctly interpret ATEX certification documentation.
Technical Review
Technical Review
This article has been technically reviewed against Directive 2014/34/EU, the European Commission's ATEX Guidelines, and the conformity assessment procedures governing quality assurance for equipment intended for use in potentially explosive atmospheres.
The guidance explains the purpose of an ATEX Quality Assurance Notification (QAN), its relationship with ATEX Module D, Module E, and the EU-Type Examination Certificate, and the role of ATEX Notified Bodies in approving and monitoring manufacturers' quality assurance systems. Readers should always consult the latest version of Directive 2014/34/EU and the applicable harmonized EN IEC 60079 standards when evaluating certification requirements.
References
- Directive 2014/34/EU of the European Parliament and of the Council.
- European Commission – ATEX Guidelines for Directive 2014/34/EU.
- EN IEC 60079 Series – Explosive Atmospheres.
- Blue Guide on the Implementation of EU Product Rules.
- ISO/IEC 80079 Series.
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