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Draft 6. Note: This document is a draft suggestion only and is not an approved document.
Please do not distribute to laboratory staff for use.
additional performance checks. Examples include the consistency of retention times and resolution of analytes in a
chromatographic system, the stability and linearity of a detector, and the resolution, alignment and wavelength
accuracy of spectrometers. Results of these performance checks shall be documented. The frequency of such
performance checks shall be specified in manuals or operating procedures based on manufacturer requirements, lab
experience, equipment type, and/or previous performance of the equipment. Intervals for performance checks should
be shorter than the time the equipment has been found, in practice, to take to drift outside acceptable limits. The
performance checks shall be satisfactorily completed before the equipment is used. The manufacturer of the
instrument may be consulted and should offer a program to ensure proper instrument performance.
Many types of equipment can affect a test result and thus will require calibration or verification as well as
maintenance. The laboratory shall have a plan and/or procedure for the calibration or verification and maintenance of
the equipment listed in Appendix A, Table 1. Appendix A, Table 1 provides minimum requirements for the
calibration and verification of critical equipment; regulations and accrediting bodies may specify additional
requirements.
5.6 Measurement Traceability
According to 5.6.1 and 5.6.2 of ISO/IEC 17025 and the ILAC Policy on the Traceability of Measurement Results
(ILAC-P10:01/2013), if the calibration of instruments used in testing contributes significantly to the overall
uncertainty of the measurement result the requirements of traceability to the International System of units should be
met. Further information about meeting the requirements for traceability are available in ILAC P10 and policy
documents provided by the individual accrediting bodies. If the equipment or instrument does not contribute
significantly to the overall uncertainty, demonstrated by calculation of a full uncertainty budget, the traceability to the
SI may not be required.
Note
: Depending on regulations, the frequency of verifications or calibrations may need to be increased; in these cases,
laboratories shall always follow the most stringent requirements to remain in compliance with their specific programs.
The following guides and policy are useful when developing and maintaining the program and procedure for
establishing trace ability:
EURACHEM/CITAC Guide: Traceability in Chemical Measurement—A guide to achieving comparable results in
chemical measurement
(2003)
http://www.eurachem.org/Meeting the traceability requirements of ISO/IEC 17025: An Analyst’s Guide, 3rd Edition
ILAC-P10 International Laboratory Accreditation Cooperation (2013 ILAC) Policy on Traceability of Measurement
Results,
5.6.3
Reference Standards and Reference Materials
5.6.3.1 Reference Standards
Reference Standards shall be stored according to the documentation supplied, unless valid reasons exist for not doing
so. Deviations from documentation should be recorded and justified appropriately. Documentation accompanying
the reference standard shall be stored in the laboratory’s record management system and available at all times.
Reference standards shall not be used past their expiry date without requalification demonstrating that they are still
suitable for use.
5.6.3.2 Reference Materials
All Reference Materials shall be labeled using an identification scheme that allows the laboratory to trace the lot of
Reference Material used in any analysis. In addition, each Reference Material shall be labeled with the date received
and expiration date. Upon receipt of the Reference Material, records shall also be kept to include name or
description, manufacturer’s lot number, assigned laboratory number, date received, manufacturer’s expiration date if
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