Section 7.1.5: Monitoring and Measuring Resources

If you use a tool to verify that a product meets requirements, that tool falls under strict ISO 9001 scrutiny. This applies to calipers, micrometers, torque wrenches, and CMM machines.

• Traceability: Calibration must be traceable to international or national measurement standards (e.g., NIST in the US).
• Identification: Every measuring device must have a unique ID and a physical sticker or digital record indicating its calibration status and due date.
• Safeguarding: Tools must be protected from adjustments that would invalidate the calibration, as well as from damage during handling and storage.

What Happens When a Tool is Found Out of Tolerance?

This is a major audit point. If a micrometer fails its scheduled calibration, you cannot simply throw it away and buy a new one. You must conduct an investigation: What products were measured with that tool since its last known good calibration? You must assess the risk to those products and potentially notify customers.