ISO 9000 Calibration
ISO 9000 calibrations are
crucial for many industries. The following is required for ISO 9000 Compliant
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
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.
Proper Training must be
documented for each discipline involved in performing the calibration.
The calibration provider must
be able to demonstrate an unbroken chain of traceability back to NIST.
All critical aspects of the
calibration must be properly documented for the certificate to be recognized by an ISO
A Comprehensive Equipment
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
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
A procedure should be
established with timeframes for recall notification, an escalation procedure, and provisions for due-date
A procedure which outlines
the responsibilities for ensuring the equipment is returned to the cal lab should be assigned and
An OOT Investigation
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.