Requirements
Traceability and ISO 9001:2015 - Objectives, means and methods

The first step in defining a traceability system is to clearly identify your needs. This is an essential step: it's the one that will help you avoid the two major pitfalls of traceability: on the one hand, amassing data unnecessarily; on the other, missing out on data that will prove vital later on.

A poor needs analysis has often given traceability a bad name. There's nothing worse than collecting data that serves no purpose and, when the time comes, not being able to find an essential piece of information when you've amassed thousands of records...

Moreover, when data is poorly collected, it's often because operators don't understand the need for it. If the usefulness of traceability is not...