0% found this document useful (0 votes)
141 views4 pages

UL ISO/IEC 17025:2005 Lab Requirements

The UL Third-Party Test Data Program allows for the testing of products using third-party facilities that meet ISO/IEC 17025:2005 standards, ensuring quality and compliance through rigorous assessments and validations. Participating laboratories must maintain proper procedures for testing, data recording, and equipment calibration, and are subject to annual reassessments by UL. All test data submitted is thoroughly reviewed for accuracy and compliance before being accepted for certification.

Uploaded by

heatcohn
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
141 views4 pages

UL ISO/IEC 17025:2005 Lab Requirements

The UL Third-Party Test Data Program allows for the testing of products using third-party facilities that meet ISO/IEC 17025:2005 standards, ensuring quality and compliance through rigorous assessments and validations. Participating laboratories must maintain proper procedures for testing, data recording, and equipment calibration, and are subject to annual reassessments by UL. All test data submitted is thoroughly reviewed for accuracy and compliance before being accepted for certification.

Uploaded by

heatcohn
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

D ATA A C C E P TA N C E P R O G R A M

UL Third-Party Test Data Program


Investigations of products by UL usually involve the testing of samples of the products. While
UL maintains extensive facilities for these purposes, it is also possible to utilize third-party test
facilities for testing of products under UL’s Third-Party Test Data Program.

The laboratory must have in place a fully documented ISO/ Purchasing services and supplies
IEC 17025:2005 laboratory quality program, physical resources,
(ISO/IEC 17025:2005 clause 4.6)
equipment, qualified personnel and procedures needed to
conduct the tests. The laboratory must be assessed by UL to ISO/ A participating laboratory must maintain procedures to purchase,
IEC 17025: 2005 and technical method demonstration before inspect and store critical consumables. Any consumables must meet
data can be accepted. technical specifications as noted in the test standard. Please see UL
document 00-OP-C0033 Laboratory Consumables for Client Labs
Initial and ongoing validation of testing methods must be
and 00-OP-C0037 Thermocouple Wire Validation for Clients Labs at
performed. After the program is established, UL will reassess
[Link]/dap > Resources > DAP Tools for more information.
a test laboratory annually. All data submitted is thoroughly
reviewed and audited by UL before being used for certification.
Nonconforming tests or calibrations
Should UL decide to pursue a third-party arrangement, the (ISO/IEC 17025:2005 clause 4.9)
following are some of the considerations.
A participating laboratory is to have procedures in place
to stop, evaluate and, when appropriate, resume testing
Requirements
when nonconforming test methods have been used. When
Assessment of laboratory operations
nonconforming testing takes place, remedial action shall
The laboratory operations must have documented procedures be taken, as appropriate. Based on the severity of the
and policies in place to assure accuracy and precision performing nonconforming tests, corrective action procedures may also
tests, obtaining data and reporting results. be required to prevent a recurrence. This also applies to test
equipment found to be out of tolerance prior to calibration. UL
The laboratory quality system shall be based on ISO/IEC shall be notified of any impact to test data accepted by UL.
17025:2005 and encompass all elements of ISO/IEC 17025:2005.
Additional UL requirements can be found at [Link]/dap > Corrective action
Resources > DAP Tools and are summarized below.
(ISO/IEC 17025:2005 clause 4.11)

Subcontracting of tests A participating laboratory must have procedures in place to


(ISO/IEC 17025:2005 Clause 4.5) implement corrective actions when nonconforming testing,
nonconforming calibrations or departures from the laboratory
Under the Third-Party Test Data Program UL does not permit the quality system policies and procedures are discovered. These
further subcontracting of tests to other parties. If tests cannot corrective action procedures are to include root cause analysis,
be conducted at the recognized laboratory the work is to be documentation of corrective actions and monitoring to assure
returned to UL to determine an appropriate source for testing. that corrective actions have been effective. UL is to be notified if
any test data is impacted.

1 For more information T: +1.847.664.1499 / E: DAP@[Link] / W: [Link]/dap


Technical records All equipment shall be in good working order and calibrated
appropriately. Each instrument shall bear a calibration sticker
(ISO/IEC 17025:2005 clause 4.13)
with both the latest calibration date and the calibration
Records are to be legible and stored and retained in such a way due date.
that they are readily retrievable. Storage must be in facilities
Records maintained for each instrument and any automated
that provide a suitable environment to prevent damage,
software are to include:
deterioration or loss. Retained records are to include quality and
calibration records and test data. • Full identification of equipment and records of its
acquisition
UL requires submittal of original data. If copies of data are
submitted, a participating laboratory must retain records of original • Detailed history of damage, malfunction, modification,
observations and derived data as well as sufficient information to maintenance and repair
establish an audit trail for each data sheet package sent to UL. • Calibration certificates

If an error is made in recording data, it is to be neatly lined out, • Records demonstrating that equipment complies with
the correct information recorded, the change initialed and a specified tolerances
reason provided for the change. Erasures, correction tape or • Current location of equipment
correction liquid are not acceptable. Please see UL document
• When appropriate, maintenance plan and all maintenance
00-OP-C0025 Data Recording and Reporting for Clients Labs at
carried out to date
[Link]/dap > Resources > DAP Tools for more information.
• Current version of all software, regardless of source,
and validation records for any software developed and
Accommodations and environmental conditions maintained by the laboratory
(ISO/IEC 17025:2005 clause 5.3)
Measurement traceability
Test areas must have proper energy resources, lighting,
temperature control, humidity control and other (ISO/IEC 17025:2005 clause 5.6.2)
environmental conditions required to conduct tests. All
Measuring equipment must be calibrated to a nationally
participating laboratories shall effectively monitor and
or internationally recognized standard of measurement or
control those factors that affect testing. Please see UL
standard reference material. When traceability is not possible,
documents 00-OP-C0035 Laboratory Ambient Conditions for
other procedures must be used to assure traceability in
Clients Labs and 00-OP-C0036 Laboratory Power Quality for
accordance with ISO/IEC 17025:2005 . The calibration frequency
Clients Labs at [Link]/dap > Resources > DAP Tools for
shall be determined to assure required accuracy between
more information.
calibrations. Generally, equipment shall be calibrated at least
annually. Any limitations of usage should be clearly indicated.
Test equipment
Note: Test equipment calibration must be conducted by an
(ISO/IEC 17025:2005 clause 5.5)
accredited calibration laboratory. Calibration laboratories
A participating laboratory must be furnished with test equipment accredited by an ILAC, APLAC or EAC Mutual Recognition
sufficient to correctly perform tests in accordance with the Agreement Signatory such as A2LA, NIST/NVLAP, UKAS, SCC,
applicable test standard or procedure. The equipment is to be NATA, JCSS, JAB, DKD, JNLA and IAS. Please see UL document
at least as accurate as specified or implied in the test standard, 00-OP-C0032 Calibration Certificate Analysis for Clients
or procedure or meet UL’s minimum accuracy requirements as Labs at [Link]/dap > Resources > DAP Tools for
specified in UL document 00-OP-C0034 Equipment Accuracy more information.
Requirements for Clients Labs at [Link]/dap > Resources >
DAP Tools.

2 For more information T: +1.847.664.1499 / E: DAP@[Link] / W: [Link]/dap


For laboratories that conduct calibrations for their own tested samples tested. These unique identifiers are to be
purposes, UL will assess traceability for compliance with ISO/ noted on the test datasheet.
IEC 17025:2005. For details of UL’s requirements for in-house • Rationale for not performing a test. The rational should be
calibration laboratories, please see UL document 00-OP-C0038 provided as part of the datasheet package submittal or as a
In-House Calibration Requirements for Clients Labs at www. cover to the completed datasheet package.
[Link]/dap > Resources > DAP Tools for more information.
Complete details can be found in UL document 00-OP-C0025
Data Recording and Reporting for Clients Labs at [Link]/
Reporting of results dap > Resources > DAP Tools.
(ISO/IEC 17025:2005 clause 5.10)

Participating laboratories are to record all observed data as Test method validation
well as a description of the test method or reference to the test Each test covered by the Third-Party Test Data Program will be
method used, e.g., standard name, standard number, edition or verified through direct assessment of the facilities, equipment,
issue date, latest revision date, clause and test name. Data are and personnel. Demonstrating proper testing methods includes
to be recorded in ink on form or standard laboratory data sheets. items such as placement and securement of thermocouples, use
Personnel at participating laboratories should use form UL data of instrumentation, use of appropriate environments including
sheets when available. placement of the product in test jigs as described in standards,
knowledge of situations that may produce erroneous data, etc.
Use of non-UL form data sheets will require further review by UL
to assure compliance with UL data recording procedures. UL may Annually each test method is to be validated through direct
apply additional fees for review of non-UL datasheets. Data sheets demonstration during the annual assessment. At any time, UL
must be reviewed for content prior to use by the laboratory. can require repeat of testing at UL test laboratories or through
the Witness Test Data Program at the participating testing
• All instruments used to record test data or environmental
laboratory. Some specific categories may require repeat testing
conditions must be recorded and correlated to tests performed
or participation in a proficiency test program.
• Customer identification, including location where tests were
performed
Oversight and audit
• Signature of the laboratory signatory Laboratory responsibilities
• Sequentially numbered pages with the total number of pages
It is a laboratories responsibility to notify UL of any changes in
recorded on the first page
equipment, personnel, etc., material to the program that take
• Typed or printed name of staff member performing the place between annual reassessments. Based on the changes, UL
test on each data sheet where results are recorded. For test may decide to reassess the facility to reevaluate conformance
data collected electronically, only the typed name of the
with the program.
technician is required

• Any chart paper, computer paper, printouts and similar Each laboratory shall name at least one signatory. The laboratory
resources must include the same information as specified signatory shall sign to each data package submitted to UL attesting
above that only qualified staff have been assigned to conduct tests, and
that consumables, equipment, environment, and data recording
• Clear identification of which samples were used for testing.
and reporting meet UL’s minimum requirements as specified above
When multiple samples are used for one test, data sheet
and in the documents located at [Link]/dap > Resources >
must clearly indicate result for each sample. When multiple
samples are used for a test program of one model or type, DAP Tools.
unique identifiers must be used to distinguish between

3 For more information T: +1.847.664.1499 / E: DAP@[Link] / W: [Link]/dap


Assessments Agreements
UL conducts annual assessments to the requirements detailed To formalize the relationship with UL, each participant must
above. These assessments include validating test methods have appropriate agreements on file with UL. Agreements
covered by UL’s scope of recognition. Assessments and need to be completed and on file with UL prior to an initial
participation in the Third-Party Test Data Program are test- and assessment or acceptance of data.
standard specific. Participation is scoped by specific tests for
specific standards. Laboratories not submitting test data under How to apply
the Third-Party Test Data Program for more than one year will be
Laboratories interested in participating in the Third-Party Test
reassessed prior to further acceptance of test data.
Data Program should contact the UL Data Acceptance Program
Customer Service team for further assistance. The DAP customer
Test data submitted service team will arrange for the appropriate business sponsor
All test data will be thoroughly reviewed and conformance with to work with the laboratory interested in providing data to UL.
requirements determined by UL. Reviews include:

• Accuracy of sample(s) tested

• Accuracy of test method used

• Test results

• Test equipment used

• Data recording procedures

• Completeness of required testing

• Appropriateness of justification for tests not conducted

UL retains the right to countercheck test data at any time.


Submittal of data does not mandate UL acceptance. Data
can be counterchecked at UL or through the Witnessed Test
Data Program.

4 For more information T: +1.847.664.1499 / E: DAP@[Link] / W: [Link]/dap

UL and the UL logo are trademarks of UL LLC © 2013, NG-0020 10/13

You might also like