What is a QAN and why does an ATEX manufacturer need one?
Abstract
A QAN (quality assurance notification) is a notified body's decision approving a manufacturer's quality system under ATEX Module D or E. It is needed where the route for category 1, M1 or category 2 electrical equipment uses those modules, and is kept by surveillance audits.
A QAN, or quality assurance notification, is the written decision of an ATEX notified body that a manufacturer's quality system for producing a certified type meets the directive. It is issued under Module D (quality assurance of the production process, Annex IV) or Module E (product quality assurance, Annex VII) of Directive 2014/34/EU. A manufacturer needs one when its conformity route for category 1 or M1 equipment, protective systems, or category 2 or M2 electrical equipment and engines uses one of these modules. The QAN is what links every unit leaving the factory to the type that was examined, and under Modules D and E it is the reason the notified body's number appears after the CE marking.
Short answer
- What it approves: not a design, but the factory's ability to build every unit like the type in the EU-type examination certificate.
- Where the name comes from: the directive requires the notified body's decision on the quality system to be "notified" to the manufacturer. The Commission's ATEX Guidelines call the resulting document a Quality Assurance Notification.
- When it is needed: for category 1 and M1 equipment and for protective systems, unless the manufacturer chooses product verification (Module F) or unit verification; for category 2 and M2 electrical equipment and internal combustion engines, unless it chooses supervised product testing (Module C1) or unit verification.
- When it is not needed: category 3 equipment, non-electrical category 2 and M2 equipment (internal production control with the technical file sent to a notified body), and components assessed by routes without a quality module.
- How it is kept: periodic audits by the notified body, possible unannounced visits with product tests, and approval of intended changes to the quality system. The directive sets no fixed validity period; the notified body can suspend, restrict or withdraw the approval.
Where the QAN fits in the ATEX routes
| Product | Design stage | Production stage | QAN needed? |
|---|---|---|---|
| Category 1 or M1 equipment, protective systems | EU-type examination (Module B) | Module D, production quality assurance | Yes |
| Category 1 or M1 equipment, protective systems | Module B | Module F, notified body examines and tests every product | No |
| Category 2 or M2 electrical equipment, engines | Module B | Module E, product quality assurance | Yes |
| Category 2 or M2 electrical equipment, engines | Module B | Module C1, tests on each product under notified body responsibility | No |
| Category 2 or M2 non-electrical equipment | Internal production control, file to a notified body | Manufacturer's own control | No |
| Category 3 | Internal production control | Manufacturer's own control | No |
| Any category | Unit verification (Module G), single items | Each item verified by a notified body | No |
Modules F and C1 avoid a quality system approval but involve the notified body in checks on each individual product. Module D covers production, final inspection and testing; Module E covers final product inspection and testing only.
What the notified body checks
Under Annex IV the manufacturer applies to a notified body of its choice with its quality system documentation and the technical documentation and certificate of the approved type. The audit team must include at least one person with experience of the product technology, and the audit includes a visit to the manufacturer's premises. The quality system must describe quality objectives and responsibilities, manufacturing and quality control techniques, the examinations and tests before, during and after manufacture with their frequency, quality records, and how effectiveness is monitored.
After approval, the notified body carries out periodic audits and may make unexpected visits, testing products if necessary. The manufacturer must tell it about any intended change to the quality system. The Commission's ATEX Guidelines state that a quality system based on EN ISO 9001 and EN ISO/IEC 80079-34 gives a presumption of conformity with the module requirements those standards cover, provided it takes the specific products into account, although other quality models are allowed.
Example: A manufacturer holds an EU-type examination certificate for a flameproof lighting fitting, category 2. To produce it in series, it chooses Module E and applies to a notified body, which may differ from the one that examined the type. After the factory audit, that body issues the QAN, and its four-digit number follows the CE marking on every fitting. The number tells market surveillance authorities which body watches production, not which body examined the design.
Common mistakes
- Treating the EU-type examination certificate as enough. Without the production module (QAN, C1 or F), category 1 and category 2 electrical products cannot be CE marked.
- Assuming a QAN lasts forever. It depends on surveillance; missed audits or major nonconformities lead to suspension or withdrawal, which notified bodies report to their authorities and to each other.
- Using the type examination body's number after CE. The number belongs to the body involved in the production phase, which is the type examination body only if that same body also issued the QAN.
- Own-brand labelling without a QAN chain. The ATEX Guidelines expect a trade agent that markets another firm's product under its own name to hold its own certificate and QAN, traceable to the actual producer's.
Related on excodex
- Quality assurance for Ex manufacturers: QAN, QAR and ISO/IEC 80079-34
- EU-Type Examination Certificates and Notified Bodies explained
- What does the four-digit number after the CE mark on ATEX equipment mean?
- Is ISO 9001 enough for a manufacturer of Ex equipment?
- Standard spaces: ATEX 2014/34/EU, ISO/IEC 80079-34
Standards and further reading
- Directive 2014/34/EU, Article 13 (conformity assessment procedures) and Annexes IV to VII (Modules D, F, C1 and E): Article 13, Annex IV, Annex VII
- European Commission, ATEX 2014/34/EU Guidelines, 6th edition (January 2026), sections on Module D and on subcontracting and trade agents: webgate.ec.europa.eu
- ISO/IEC 80079-34:2018, application of quality management systems for Ex product manufacture
This article is general technical information prepared by the excodex editorial team. It does not replace the applicable standards, the equipment certificates and instructions, national regulations or the assessment of a competent person.