Certification of a full quality assurance system by a notified body (NB) enables a manufacturer to guarantee the conformity of all machinery produced under this system. This certification makes it unnecessary for the NB to assess each piece of equipment individually.
Applus+ Laboratories has obtained ENAC ISO/IEC 17065 accreditation (C-PR054
accreditation) to act as a notified body for the conformity assessment of full quality assurance systems, as defined in Annex X of the Machinery Directive. Applus+ is the first Spanish body to be accredited to carry out these types of assessment. In achieving this accreditation, it therefore widens its portfolio of testing and certification services to the industrial sector.
Applus+ has extensive experience in assessing machine safety. It has been a notified body for the Machinery Directive since 1999, initially providing EC type-examination services and now broadening its scope to include full quality assurance.
What is Annex X of the Machinery Directive?
To gain access to the European market, industrial machinery must meet the safety requirements set out in Directive 2006/42/CE. This directive differentiates between two types of machinery according to how hazardous they are considered to be. Machinery classified as hazardous (Annex IV) must undergo a conformity assessment by a notified body in order to obtain CE marking.
Annex X of the directive details an alternative way of assuring the conformity of hazardous machines: certification of a full quality assurance system. This method permits a manufacturer to develop a full quality assurance system that will subsequently be approved and monitored by a notified body. As such, the manufacturer can claim the conformity of all machinery produced under this quality system, thereby saving money by not having to assess each piece of equipment individually.
If a quality system is in line with the requirements of the directive, it will receive Notified Body approval. In this case, the manufacturer or manufacturer’s representative can claim the conformity of all machinery manufactured on the basis of the approved system. To do so, they must produce an EC declaration of conformity that indicates the relevant notified body – NB 0370 in the case of Applus+ Laboratories (LGAI TECHNOLOGICAL CENTER, S.A.) – and affix the CE marking with the notified body reference to the machine in question.
In addition to the practical and cost benefits of developing and certifying a full quality assurance system, the existence of such a system is also a symbol of quality for end clients. Through an independent evaluation, full quality assurance recognises a manufacturer’s ability to implement a quality system for machinery design and production that serves to guarantee the safety and conformity of that machinery over time.