Archive for June 10th, 2009

Auditing Calibration: ISO 9001

Wednesday, June 10, 2009
posted by qicguru 8:00 AM

mpj0439343000011In the internal auditing of monitoring and measuring processes, it is important for auditors to understand the difference between monitoring and measuring:

 

1.      monitoring implies observing, supervising, keeping under review (using monitoring devices); it can involve measuring or testing at intervals, especially for the purpose of regulation or control

2.      measuring considers the determination of a physical quantity, magnitude or dimension (using measuring equipment)

 

Section 7.6 of the ISO 9001:2008 standard requires that an organization must determine the monitoring and measurement to be done and the monitoring and measurement equipment needed to provide evidence of conformance of products to requirements.

 

Auditors should confirm that, in addition to providing the necessary calibration records and assuring the related measurement uncertainty and traceability, their organization is aware of and has implemented, as appropriate, a metrological confirmation system as described in ISO 10012 adequate to the extent and types of the measurements performed.

 

The internal auditor needs to understand how their organization performs process control and the impact that the information, obtained from using these “devices”, has on this process control.

 

When the impact is relevant, auditors should evaluate issues such as:

 

-       How their organization validates that “the monitoring and measuring device” is consistent with the monitoring and measurement requirements.

-       How their organization assures the information validity.

-       The competence of the responsible to design “the monitoring and measuring device”

-       How their organization validate the consistency of the results

 

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