Especially medium-sized companies such as dacore Datenbanksysteme AG typically do not have a Q department that can permanently take care of the manual maintenance of a document-based QM system. That's why smart solutions are needed. The realization of the rebuilding of the system at dacore was that the limit is not how far you can go, but rather how far you are willing to go yourself. The standards allow it and experience shows that the auditors are also very open-minded
Information instead of documents
Key topics that stem from the Industrie 4.0 environment and that are important for further consideration are "digitization", "linking data" and "transparency". In this context, the focus is on "information", which will be very relevant later.
Not unlike Industry 4.0, there are many analogies to paradigm shifts in the past. The first cars were carriages without horses, the first TV movies were filmed plays and the first step towards QM System 4.0 or digitization seems to be the removal of paper manuals through electronic manuals. It may be necessary to go through such developments. Definitely, however, significantly more extensive changes are necessary but already possible today to actually achieve serious improvements: Reduction of descriptions, easier maintenance, better acceptance of employees and above all the highest transparency and proof of the effectiveness of the QM system, which results practically on its own , The use in self-experiment at dacore showed that it not only works but in total also means less effort.
The current standards are already prepared for this. Chapter 4.2 of ISO 9001: 2015 describes e.g. "The scope of the organization's quality management system must be available and maintained as documented information". Furthermore, the organization has to "maintain documented information to support the execution of its processes", etc. So the standard is no longer about manuals or documents but about information.
Actually, good conditions.
Read more in artricle Information instead of documents in the attachment or in QZ online magazine.