Traceability and ISO 9001:2015 – Objectives, means and methods

Traceability is sometimes seen as an onerous and tedious constraint. It's true that, for a long time, based on a mass of forms and sheets to fill in, it was a real headache for operators, especially as many times, when information was sought afterwards, it was precisely this information that was missing, because the cumbersome nature of the system meant that there were "holes" in the system: either because the form had been mislaid, or because it had been filled in incorrectly, or because, quite simply, it was impossible to find one's way through the jumbled archives.

Digitization has brought about a revolution. It has made it possible for every device to be equipped with sensors, RFID tags and other measuring devices that send parameters directly to the information network, or, if the data is still collected manually, entered on a tablet that integrates it directly into the information system. As a result, we often move from a scarcity of information to an over-abundance, or even to "mass data" that specialized software has to process. In this way, we can also keep track of the entire production cycle, including that of subcontractors, which can be extremely valuable.

Increasingly, traceability is no longer simply a matter of collecting historical data, but is also becoming a real aid to design, through the detailed knowledge of products it provides, and to safety, through the detection of deviations and risks at different stages of production and, sometimes, use. This goes beyond the requirements of the standard, but a good approach must be global, and therefore take these new possibilities into account.

This poses new challenges for implementation: the right targeting of the data to be collected, the consistency of data throughout the chain so that it can be digitally assembled, the confidentiality of data covered by industrial secrecy, protection against intrusions and malware, the development of the operating system, often with remotely distributed users...

At the same time, traceability frequently becomes a major, even vital, issue. Think of epizootics, product returns due to faulty workmanship, lawsuits following accidents... Our society's desire not to accept risk, and to want to know and control everything to this end, places traceability at the forefront of producers' and customers' concerns.

It is therefore in the interests of companies and public authorities to take advantage of certification to take stock of their internal traceability, with the aim of improving risk prevention, product knowledge and internal management, while eliminating unnecessary formalities.

This dossier lays the foundations, showing how best to use the requirements of ISO 9001:2015....