Quality management systems affect several processes, products and services worldwide.
Depending on the risk potential of the products, the requirement for “surveillance” (Audits) of the manufacturer often arises. This is then performed by a notified body (NoBo).
The ISO 9001 standard makes an important contribution to the CE conformity of products and services. For ATEX / IECEx manufacturers it can be understood as a starting point and is supplemented by the requirements of ISO 80079-34. Annex X of the Machinery Directive 2006/42 / EC also states that an effective Quality management System is justified.
In terms of product liability and associated risk minimization, an effective QMS is often indispensable.