ISO 9000 Calibration
ISO 9000 calibrations are crucial for many industries. The following
is required for ISO 9000 compliant calibrations.
Accredited Calibration Lab
The calibration laboratory employed to perform the calibration must be an ISO
9001:2000 accredited lab or be the original equipment manufacturer.
Documented Calibration Procedures
It is critical that a valid calibration procedure be used based on the
manufacturer’s recommendations and that it cover all aspects of the instrument
under test.
Trained Technicians
The proper training of each technician 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 National Institute of Standards and Technology (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:
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.
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