EN 13980 - Demands on quality management systems

EN 13980 concerns a harmonized standard within the scope of the ATEX directive RL 94/9/EG. It governs the demands on quality management systems in compliance with annex IV and VII respectively, of ATEX95.

The so called “presumption effect” applies if a manufacturer of explosion proof equipment makes the decision to become certified in accordance with this standard. This means that the legislative body “may presume” that a manufacturer is conducting himself properly in terms of the mandatory conformity assessment and that he has satisfied the legal provisions in the area of the production phase.

EN 13980 is based like ISO 9001:2008 on the “process oriented approach”. The difference when compared with ISO 9001 among other things is that EN 13980 completely eliminates the development process. This development process is typically covered by means of the EC-type examination. Furthermore, the fourth major process which concludes the cycle of ISO 9001 is also missing, namely that of “continuous improvement”. The reason for the exclusion lies in the nature of the conformity assessment procedure. The manufacturer has already had to supply proof, upstream, in the EC-type examination, that the “basic safety and health requirements” (GSGA) are satisfied. The QM system must make sure in the production phase that each individual device satisfies the GSGA requirements in compliance with annex II of the directive. The manufacturer’s potential to “continuously improve” the product would, according to the requirement, clearly contradict uninterrupted adherence to the GSGA requirements.
The most prominent difference between the requirements on QM systems in compliance with Annex IV (Production) and Annex VII (Product) lies in the area of auditing. While the QM “Production” system stipulates that certain audits are to be performed and documented on each individual product “before, during and after manufacture” the audit is limited in compliance with annex VII to the final inspection of each individual product.

A previous certification of the quality management system of a manufacturer (e.g. according to ISO 9001) is taken into proper consideration during the assessment by the notified body. This notified authority needs only to assess how the quality management system is taking care that the requirements presented in the EC type approval test and the demands of the directives that apply are being observed.

Unfortunately, the standard does not regulate the issuance of the EC conformity declaration and the attachment of the CE label so that a manufacturer cannot make the assumption with the successful certification in accordance with EN 13980, that he has satisfied all of the stipulations for placing the explosion proof devices, equipment or protective systems on the market.   Of course, as the certifying body we are happy to help you so that these gaps can be closed as well.

EN 13980 differs from ISO 9001 in another important point because it involves a standard, which establishes the requirements on quality management that is “product specific”: The precondition for the certification according to this standard is that a manufacturer must possess at least one valid EC type-examination certificate.

As a matter of integrity, we must add that the manufacturer has the choice of at which notified body he has the EC type approval test performed and on which certifying authority he calls in for the expert opinion of the quality management system in compliance with EN 13980. The ATEX directive does not specify that the same notified body is to be used for the development phase and for monitoring of the production.