Calibration of measuring equipment in ISO 9001

Key terms

• Calibration: comparing an instrument with a more accurate standard. The result is the deviation, not automatically an adjustment.
• Adjustment: setting the instrument so that the deviation becomes as small as possible.
• Verification: confirming that the instrument meets specified requirements, such as a maximum deviation.
• Traceability: an unbroken chain of comparisons up to national or international standards. Where none exists, the basis for calibration is documented.

What ISO 9001 requires

1. 1

   Ensure suitability

   Equipment fits the measurement task, for example in resolution and range.

2. 2

   Calibrate or verify

   At specified intervals or before use, against traceable standards.

3. 3

   Identify

   Calibration status is recognisable, for example by a label or a list.

4. 4

   Safeguard

   Against adjustment, damage or deterioration that would invalidate results.

5. 5

   Assess when unfit

   If equipment is found unfit, determine whether earlier results are affected and act if necessary.

Evidence of fitness for purpose must be retained as documented information. The last step is the one most often forgotten in practice and a popular audit question.

In daily operation

An equipment list with number, name, location, interval, last and next date and result has proven useful. Calibration intervals depend on manufacturer guidance, frequency of use and experience. External calibration labs are external providers and are evaluated, usually with little effort if they are accredited.

Implementing it in docxpert

docxpert does not manage individual instruments with calibration dates. Use a specialist system or a controlled list for that. The “Monitoring and measuring equipment” template in the template library describes the procedure. You record equipment without valid calibration as a deviation in deviation management and assess the impact on earlier results there.