Quality control, ISO 9001 and traceability in production
How a quality management system hangs together with your daily work at the machine
Many production companies are certified to ISO 9001 an international standard for quality management systems. For you at the machine the standard is not about abstract papers but about some very concrete routines: how an error is handled how a part can be traced and how you document that the work is done correctly.
§What is a quality management system?
ISO 9001 sets requirements for how a company builds, operates and continuously improves a system to ensure quality in what it delivers. The standard covers, among other things, requirements for the product or service itself, for the production process, and for how deviations and improvements are handled. It is not a system that exists alongside production – it is intended as an integrated part of how tasks are solved every day.
§Deviations — when something doesn't meet the requirement
A deviation is when a product or process does not meet a requirement — what the standard calls nonconforming output. ISO 9001:2015 places specific requirements on how such a deviation is managed (section 8.7 on control of nonconforming output) and on how to find the cause and correct it so the error does not repeat (section 10.2 on nonconformities and corrective action). In practice, this means that a scrapped part is not just thrown away — it is recorded, the cause is investigated, and action is taken if the error is due to a machine, a program or a work process that could affect multiple pieces.
§Traceability and documentation
Traceability means a finished part can be traced back to the material it was made of, the machine and program it was processed with, and the dimensions it was checked against. ISO 9001 requires controlled documentation of decisions, processes, and work instructions, precisely to ensure this traceability and version control – and to ensure changes go through a controlled process so everything is connected backwards. In industries such as medical, energy, and food, traceability requirements are particularly high because an error can have serious consequences.
| Concept | What it means in practice |
|---|---|
| Quality management system | The fixed routines that ensure quality does not depend on chance |
| Deviating output | A part or process that does not meet the requirement |
| Corrective action | Finding and removing the underlying cause of a deviation |
| Traceability | To be able to trace a part back to material, process and control |
§Why it concerns you as a technician
Quality control sounds like something that happens in an office, but in practice it is carried by those standing at the machine. Your measurement, your completed control sheet and your report of a deviation are the data the system is built on. The more accurately and honestly you document your work, the better the company can catch errors early, improve processes — and avoid the same error costing time and material again and again.
“A quality management system is only as good as the data it gets from the workshop floor — and you deliver that.”