00 Op C0038
00 Op C0038
00 Op C0038
Requirements/ Procedures
Validation of calibration
management system
Confirmation of calibration
systems
Records
Certificates, Approval
Forms, and Other
Documentation
PURPOSE ..................................................................................................................................... 3
2.0
SCOPE .......................................................................................................................................... 3
3.0
DEFINITIONS ............................................................................................................................... 3
4.0
GENERAL ..................................................................................................................................... 5
4.2
4.3
5.0
5.2
5.3
6.0
6.2
6.3
7.0
8.0
9.0
10.0
APPENDIX A
10.1
11.0
ACCREDITATION ENDORSEMENTS............................................................. 15
PURPOSE
1.1.1
2.0
This document provides the minimum requirements for calibration related processes to
be applied where UL Data Acceptance Program participants perform in-house
calibrations of their own laboratory test instrumentation or utilize non-accredited
calibration service providers for specialized equipment or where no accredited calibration
services exist.
SCOPE
2.1.1
3.0
DEFINITIONS
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
Measuring and Test Equipment (M&TE) - all devices used to gauge, measure, test,
inspect, or otherwise determine compliance with prescribed technical requirements.
3.1.7
3.1.8
3.1.9
3.1.10 Reference Material - Material or substance one or more of whose property values are
sufficiently homogeneous and well established to be used for the calibration of an
apparatus, the assessment of a measurement method, or for assigning values to
1
materials.
3.1.11 Traceability - The property of the result of a measurement or the value of a standard
whereby it can be related to stated references, usually national or international standards,
through an unbroken chain of comparisons, all having stated uncertainties. The level of
traceability establishes the level of comparability of the measurement essentially,
whether the result of a measurement can be compared to the previous one, a
measurement result made a year ago, or to the result of a measurement performed
2
anywhere else in the world.
GENERAL
4.1.1
4.2
Calibration Sources
4.2.1
For test laboratories providing in-house calibration services for their own M&TE:
1.
2.
In certain cases non-accredited calibration labs must be utilized, where unique skill or
knowledge of a specialized calibration process is required, such as the original
equipment manufacturer (OEM) or a specific calibration lab having certain resources to
perform the required calibration.
4.3.2
Prior to selecting a non-accredited calibration supplier, the test laboratory must exhaust
all potential accredited laboratories first. If the calibration service provider is not
accredited for the particular calibration being provided, the test laboratory must audit the
calibration document(s) and the traceability of the calibration(s) to confirm traceability to a
national metrology institution.
4.3.3
The results of this audit must be documented and retained by the test laboratory. An
example of an assessment form is found in Appendix B. Participants may utilize other
types of assessment as long as all critical aspects identified in the example form have
been documented.
4.3.4
4.3.5
Citation of a NIST test number, certification of the calibration lab to ISO9001, a simple
statement of traceability to NIST (or international standard) by the calibration service
provider is not acceptable evidence of traceability. The calibration certificate and related
records must provide evidence that the calibration service provider utilized calibration
standards that are traceable to national standards. See 5.1.4 below.
Equipment (calibration standards) (5.5) In-house calibration services must have all
the calibration standards and reference materials available for the calibrations performed.
5.1.2
5.1.3
The calibration standards and any related software shall be maintained in accordance
with the following:
i. Identity of the item and any related software (software version and/or date)
ii. A unique identification number such as the manufacturers name, an assigned
identification number or model and serial number.
iii. The manufacturers instructions or operating manual.
iv. Calibration records - including adjustments made, certificates, next calibration date
and calibration dates.
v. Calibration records and procedures shall clearly specify when the calibration of the
instrument expires. For example: a label or recording stating Calibration Due
January 2, 2000 requires calibration to be performed by January 1, 2000. A label or
record stating Calibration expires January 1, 2000 requires calibration by January 2,
2000. Where specific day of month is not provided in calibration records (e.g.
January 2000), a procedure shall be used to specify how the recalibration dates are
determined.
5.2
5.1.4
5.1.5
The calibration certificates issued by In-house calibration services shall contain the
measurement results (calibration data) and must include a measurement uncertainty
statement for the calibration standards or a statement of compliance to an accepted
metrological specification.
5.3
6.0
5.2.1
5.2.2
Calibration certificates and reports must include statements of the measurement results
(calibration data) and the associated uncertainty of measurement value.
5.3.2
5.3.3
There shall be effective separation between neighboring areas in which there are
incompatible activities. Examples: Vibration from an accelerometer calibration may
affect a load cell calibration. Drafts from an airflow measurement may affect a
thermocouple calibration process. Distance or appropriate barriers must separate these
calibration activities.
6.3
Methods (procedures) (5.4) In-house calibration laboratories shall have methods and
procedures for all calibrations that are performed. Documents of calibration procedures
are to be available to personnel performing in-house calibrations (5.4.1). All instructions,
manuals and other information regarding the use of calibration standards and the
resulting estimation of measurement uncertainty are required to be available and up-todate.
6.2.2
6.2.3
6.3.2
7.0
Each in-house calibration service is to maintain records of every event where nonconforming calibration work is found. A calibration standard found to be out-of-tolerance
or data recording errors that require corrective actions are examples of non-conforming
work (4.9).
7.1.2
In some cases, the test instrument specifications given by the manufacturer may be
many times more accurate than the requirements in the test standard or the UL default
tolerance values.
Where an instrument is found to be out of tolerance with the manufacturers
specification(s) but it has been demonstrated through calibration that the instrument is
within the specification of the test standard or the default tolerances provided by UL, use
of the test data acquired with the instrument would be considered acceptable and no
further action is required with respect to notification of UL or traceback of prior projects.
Where no tolerances are identified for the test method, UL is to be notified of out-oftolerance conditions relative to the manufacturers specifications.
The client's procedures in 7.1.2 addressing non-conforming events and the related
records required in 7.1.1 are to be applied in each instance of a non-conforming
calibration. Corrective actions are to be made within the clients calibration management
system to reduce or eliminate reoccurrences of out-of-tolerance conditions that may
impact future test data submittals to UL.
8.0
In-house calibration laboratories must retain the following supplier evaluation records:
a. Information regarding the accreditation of the calibration service provider who
performed calibration of the In-house standards. Access to the certificate(s) from
the accreditation organization listing the scope of coverage for the calibration
service provider is sufficient.
b. An assessment is to be performed for non-accredited calibration service
providers. Results of the survey are to be retained by the In-house calibration lab
or the test laboratory.
c.
RECORD RETENTION
9.1.1
10.0
APPENDIX A
ACCREDITATION ENDORSEMENTS
Company Name:
Address:
City:
State
Zip:
PLEASE COMPLETE THE FOLLOWING INFORMATION:
Technical Manager:
Phone No.:
FAX No.:
Email:
Person Completing
Survey:
Title:
Date:
SCOPE OR TYPE OF CALIBRATIONS TO BE MADE
(Entity conducting survey to complete this information)
NO
YES
NO
NO
N/A
NO
YES
NO
YES
NO
1.2
Recommended
1.2.1
1.2.2
1.3
Recommended
2.0 Calibration Facilities:
2.1
Required
2.2
Required
2.2.1
2.2.2
2.2.3
2.2.4
2.2.5
2.2.6
2.3
2.4
2.4.1
2.4.1.1
2.4.1.2
2.4.1.3
Required
Required
Not Applicable
Required
Required
Required
Required
Required
Not Applicable
Recommended
Recommended
Recommended
2.5
Required
2.6
Required
4.1.3
4.3
5.1
6.1
6.2
Required
Not Applicable
No Exceptions
Based on 2.8 this is informational, however, if other than fixed at
one year additional information should be
requested and reviewed.
No Exceptions
No Exceptions
No Exceptions
Required
Required
2.9
Required
3.0 Specific Calibration Procedures
3.1
Required
Applicable when measurement is of the self calibration type.
3.1.1
Required
3.1.2
Required
3.2
Required
Applicable when equipment includes internal calibration.
3.2.1
Required
3.2.2
Required
3.3
Required
Applicable when the calibration system is to be calibrated as a
complete system.
3.3.1
Required
3.3.2
Required
3.4
Required
3.4.1
Required
4.0 Documentation of Calibration Results:
4.1
Required
No Exceptions
4.1.1
Required
No Exceptions
4.1.2
Required
No Exceptions
Recommended
However, calibration labels may be placed on equipment by the
end user based on vendors supporting
documentation.
4.2
Recommended
However, seals may be placed on the equipment by the end
user prior to releasing the equipment for use.
Required
No Exceptions
4.3.1
Required
No Exceptions
5.0 Documentation of estimated uncertainty:
Recommended
See note 2.7
5.1.1
5.1.2
6.0 Staff qualifications:
Required
No Exceptions
Recommended
Further investigation may be required for a negative response.
UL does not endorse any vendors or products referenced herein.
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INFORMATION. UL MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND WHATSOEVER, WHETHER EXPRESS
OR IMPLIED, WITH RESPECT TO THE ACCURACY, CONDITION, QUALITY, DESCRIPTION, OR SUITABILITY OF THIS
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Copyright 2012 UL LLC. All rights reserved. May not be reproduced without permission. This document is controlled and has
been released electronically. The version on the UL intranet is the up-to-date document. Hard copies are uncontrolled and may
not be up-to-date. Users of hard copies should confirm the revision by comparing it with the electronically controlled version.
00-OP-C0038 Issue 4.1
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