ISO 9001:2015 defines general principles and terms relating to quality management. It also defines the minimum quality management requirements that an organisation must meet in order to manufacture products that are recognised by the authorities.
The latest revision of the norm took place in the year 2015. Among other things, this states that processes must be validated which cannot be monitored during their creation and where the result only becomes evident in the end. Accordingly, the components supporting this process, including the software, must also be validated. It is stated here that documented information including those using software must be identifiable and assignable, have an adequate format and must be subject to a respective validation and approval. The subject of regular control of all data and documents and their management is also given appropriate consideration in this standard.
The certification of the norms is conducted by established authorities such as the TÜV (Technischer Überwachungsverein). The norms ISO 9001 as well as ISO 13485 provide a legal basis of special significance for organizations operating internationally.