ATEX Module E Explained
ATEX Module E is the conformity assessment procedure known as Conformity to Type Based on Product Quality Assurance under Directive 2014/34/EU.
Module E requires the manufacturer to operate an approved quality system for final product inspection and testing. The purpose is to ensure that products placed on the market conform to the type described in the applicable EU-Type Examination Certificate.
An ATEX Notified Body assesses the quality system and performs surveillance to verify that the approved system continues to be maintained and applied. The manufacturer remains responsible for ensuring and declaring product conformity.
What Is ATEX Module E?
Module E is defined in Annex VII of Directive 2014/34/EU.
The formal title is:
Conformity to Type Based on Product Quality Assurance
Unlike Module D, which covers quality assurance of the production process, Module E concentrates on the manufacturer's quality system for final product inspection and testing.
The manufacturer operates the approved quality system, while the Notified Body assesses and surveils that system.
The objective is to provide assurance that the finished products conform to the approved type and the applicable requirements of the ATEX Directive.
Where Does Module E Fit in the ATEX Conformity Assessment Process?
Module E is a conformity-to-type procedure. It is therefore based on an approved type described in an EU-Type Examination Certificate where Module B forms part of the applicable conformity assessment route.
The basic relationship is:
| Stage | Module | Function |
|---|---|---|
| Type examination | Module B | Examines the product type and issues the EU-Type Examination Certificate |
| Product quality assurance | Module E | Ensures final products are inspected and tested under an approved product-quality system |
However, Module E is not universally required for every ATEX product. Directive 2014/34/EU specifies which conformity-assessment combinations apply to different equipment groups and categories. For example, Article 13 provides Module E as one of the available routes for certain Group I and Group II Category 2 equipment.
What Does Module E Require From the Manufacturer?
The manufacturer must operate an approved quality system for final product inspection and testing of the products concerned.
The quality system must ensure that the products conform to the type described in the EU-Type Examination Certificate and to the applicable requirements of Directive 2014/34/EU.
The manufacturer's quality-system documentation must be organized so that quality programmes, plans, manuals, procedures, and records can be consistently interpreted and applied.
The application to the Notified Body must include, among other information:
- Manufacturer identification and address.
- A declaration that the same application has not been lodged with another Notified Body.
- Relevant information concerning the product category.
- Documentation concerning the quality system.
- Technical documentation of the approved type.
- A copy of the EU-Type Examination Certificate.
These requirements are specified in Annex VII, Section 3.1.
What Does the Product Quality System Cover?
Module E is narrower than Module D because its quality system is centered on final product inspection and testing.
The system can include controls for:
- Final inspection procedures.
- Final product testing.
- Acceptance and rejection criteria.
- Inspection and test records.
- Calibration of inspection and test equipment.
- Identification and traceability of finished products.
- Control of nonconforming products.
- Corrective actions.
- Quality documentation and records.
- Competence of personnel performing inspection and testing.
The specific procedures must be appropriate to the products and the requirements being assessed.
How Does the ATEX Module E Process Work?
A simplified Module E process is:
- The applicable product type is examined under the required conformity assessment route, including Module B where required.
- The manufacturer establishes a product quality assurance system covering final inspection and testing.
- The manufacturer submits the quality-system application to a Notified Body of its choice.
- The Notified Body assesses the quality system.
- If the requirements are satisfied, the quality system is approved.
- The manufacturer operates the approved system during production.
- Final products are inspected and tested according to the approved procedures.
- The Notified Body performs surveillance of the approved quality system.
The manufacturer remains responsible for ensuring and declaring that the products conform to the approved type and applicable ATEX requirements.
What Does the Notified Body Assess?
The Notified Body assesses whether the manufacturer's product quality system satisfies the requirements of Module E.
The assessment can cover:
- Quality-system documentation.
- Final inspection procedures.
- Product testing procedures.
- Acceptance criteria.
- Inspection and test records.
- Calibration arrangements.
- Control of nonconforming products.
- Corrective-action procedures.
- Personnel competence.
- Quality records.
The assessment is not the same as a full audit of the entire manufacturing process under Module D.
What Happens After Module E Approval?
Approval of the quality system is followed by ongoing surveillance.
The Notified Body must verify that the manufacturer maintains and applies the approved quality system.
Surveillance can include:
- Periodic audits.
- Review of quality-system documentation.
- Review of inspection and test records.
- Verification that the approved procedures remain implemented.
- Assessment of corrective actions.
The Directive also permits the Notified Body to make unexpected visits. During such visits, it may carry out or arrange product tests when necessary to verify that the quality system is functioning correctly.
Module E vs Module D
Module D and Module E are closely related because both use an approved quality system and both are conformity-to-type procedures. The important difference is what the quality system covers.
| Module E | Module D |
|---|---|
| Product Quality Assurance | Production Quality Assurance |
| Focuses on final product inspection and testing | Covers the production process, final inspection and testing |
| Quality system is centered on finished-product quality | Quality system covers manufacturing and production controls |
| Based on the approved type | Based on the approved type |
| Notified Body surveils the product-quality system | Notified Body surveils the production-quality system |
The European Commission's Blue Guide describes the distinction by noting that Module E focuses on product quality, while Module D covers the production process, including manufacturing and final-product inspection.
Module E vs Module C2
Module E and Module C2 use different mechanisms to establish continued conformity after the applicable type examination.
| Module E | Module C2 |
|---|---|
| Product Quality Assurance | Internal Production Control Plus Supervised Product Checks at Random Intervals |
| Uses an approved product quality system | Uses internal production control with supervised product checks |
| Focuses on final inspection and testing procedures | Focuses on supervised checks of products at random intervals |
| Notified Body assesses and surveils the quality system | Notified Body performs supervised product checks |
Module C2 is defined in Annex VI, while Module E is defined in Annex VII of Directive 2014/34/EU.
Is Module E the Same as ISO 9001?
No.
ISO 9001 is a general quality-management standard. Module E is an ATEX conformity assessment procedure specifically concerned with product quality assurance for products covered by the applicable ATEX conformity route.
A manufacturer may have ISO 9001 certification, but this does not by itself establish compliance with Module E.
The Notified Body must assess the relevant quality system against the applicable Module E requirements.
Does Module E Mean the Notified Body Tests Every Product?
No.
Module E is based on an approved quality system for final product inspection and testing. The manufacturer operates that system and remains responsible for product conformity.
This is different from Module F, where the Notified Body verifies conformity through examination and testing of every product. Under Module F, the Directive specifically requires every product to be individually examined and tested.
Does Module E Replace Module B?
No.
Module E is a conformity-to-type procedure. Where the applicable conformity assessment route requires Module B, Module E operates in conjunction with the approved type described in the EU-Type Examination Certificate.
Module E does not itself perform the EU-Type Examination.
In simple terms:
Module B = examination of the product type.
Module E = product quality assurance for production conformity to that type.
What Should Engineers and Procurement Teams Check?
When a supplier states that an ATEX product is assessed under Module E, the following documents should be checked together:
- EU-Type Examination Certificate, where Module B is part of the applicable route.
- Module E quality-system approval or relevant Notified Body documentation.
- Manufacturer name and address.
- Product identification and model/type designation.
- Scope of the approved quality system.
- Applicable equipment group and category.
- Product marking.
- EU Declaration of Conformity.
- Relevant special conditions or certificate limitations.
The important point is that an authentic Module E approval does not by itself prove that a particular product is suitable for a particular hazardous area. Product identification, marking, certification scope, installation requirements, and the applicable conformity-assessment documentation still need to be checked.
Common Misunderstandings About ATEX Module E
Module E Is the Same as Module D
No. Both are quality-assurance-based conformity procedures, but Module D covers quality assurance of the production process, while Module E focuses on product quality assurance through final product inspection and testing.
Module E Is the Same as ISO 9001
No. ISO 9001 is a general quality-management standard. Module E is a specific ATEX conformity assessment procedure.
Module E Means the Notified Body Tests Every Product
No. Module E is based on the manufacturer's approved product quality system. Individual-product verification by the Notified Body is characteristic of other procedures, such as Module F.
Module E Replaces Module B
No. Module E is a conformity-to-type procedure. Where Module B is required, Module E is used with the approved type described in the EU-Type Examination Certificate.
Module E Is Only a One-Time Approval
No. The quality system remains subject to surveillance by the Notified Body.
Frequently Asked Questions
What is ATEX Module E?
ATEX Module E is Conformity to Type Based on Product Quality Assurance. It requires the manufacturer to operate an approved quality system for final product inspection and testing.
Who approves the Module E quality system?
An ATEX Notified Body assesses the manufacturer's quality system and performs surveillance after approval.
Does Module E use an EU-Type Examination Certificate?
Module E is a conformity-to-type procedure and therefore relies on the approved type described in an EU-Type Examination Certificate where Module B forms part of the applicable route.
What is the difference between Module D and Module E?
Module D covers quality assurance of the production process, including manufacturing and final product inspection/testing. Module E focuses on the quality system for final product inspection and testing.
What is the difference between Module E and Module F?
Module E uses an approved product quality assurance system. Module F uses product verification by the Notified Body, including examination and testing of every product.
Does Module E require surveillance?
Yes. The Notified Body conducts surveillance to verify that the manufacturer maintains and applies the approved quality system.
Conclusion
ATEX Module E is the conformity assessment procedure for Product Quality Assurance. It focuses on the manufacturer's approved quality system for final product inspection and testing and is intended to ensure that finished products remain conforming to the applicable approved type.
The main distinction from Module D is the scope of the quality system:
Module D → quality assurance of the production process.
Module E → product quality assurance, focused on final inspection and testing.
The manufacturer remains responsible for product conformity, while the ATEX Notified Body assesses and surveils the approved quality system.
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