External Regulatory Requirements
Use of reference materials

All conformity assessment standards that rely on decisions based on numerical results include requirements related to the control of measurement processes and, consequently, to traceability to a coherent system of units. Whenever measurement results influence a conformity decision, these requirements become essential.

The most general requirements are set forth in ISO 9001, particularly in the section on control of monitoring and measuring equipment, which stipulates that when measurement results are required to demonstrate product conformity, measuring equipment must be calibrated or verified to ensure the validity of the results obtained.

These requirements for the management of measurement processes are detailed in ISO 10012, which aims to help organizations control their measurement processes. In this context, reference materials are...