ISO 9000 calibrations are crucial for many industries. The following is required for ISO 9000 Compliant Calibrations.

An Accredited Calibration Lab Performing the Work:

The calibration laboratory employed to perform the calibration must be an ISO 9001:2000 accredited lab or be the original equipment manufacture.

Documented Calibration Procedures:

It is critical that a valid calibration procedure be used based on the manufacture’s recommendations and covering all aspects of the instrument under test.

Trained Technicians:

Proper Training must be documented for each discipline involved in performing the calibration.

Traceable Assets:

The calibration provider must be able to demonstrate an unbroken chain of traceability back to NIST.

Proper Documentation:

All critical aspects of the calibration must be properly documented for the certificate to be recognized by an ISO auditor.

A Comprehensive Equipment List:

For any manufacture to pass an ISO audit regarding calibration they must demonstrate that they have a comprehensive equipment list with controls in place for additions, subtractions and custodianship of equipment.

Calibrated and NCR Items Properly Identified:

The equipment list must identify any units that do not require calibration and controls must be in place to ensure that these units are not used in an application that will require calibration.

A Proper Recall System:

A procedure should be established with timeframes for recall notification, an escalation procedure, and provisions for due-date extension.

Equipment Custodianship:

A procedure which outlines the responsibilities for ensuring the equipment is returned to the cal lab should be assigned and delegated.

An OOT Investigation Log:

Any instrument found out of tolerance requires that an investigation be performed to determine the impact on manufacturing. Records and reports need to be maintained.