under the ILAC Arrangements on Calibration and Testing / F07/24
Laboratory Name:
Address:
Laboratory representative:
Standard Assessed to:
(ISO/IEC 17025:2005 or
ISO 15189:2012)or ISO/IEC17020 or ISO/IEC 17065
Laboratory type
(Calibration, Testing or Medical)
Place of assessments
(specific lab)
Assessment Dates:
Assessor(s):
Technical expert(s)
Assessment Type
1) CALIBRATION LABORATORIES ASSESSED UNDER
THE ILAC ARRANGEMENT ON CALIBRATION
Requirements / C NC NA / Comments / Evidences for meeting the requirement/
1.1 Direct traceability to SI units is possible and practical
1.1.1Check whether all equipment used for calibrations, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the calibration has been calibrated before being put into service.
1.1.2 Check whether the laboratory has an established program and procedure for the calibration of its equipment.
1.1.3 Check whether the laboratory can justify the need for the calibration (or not) ofall of its equipment used for calibrations.
1.1.4 Check whether the program for calibration of equipment is designed and operated so as to ensure that calibrations and measurements made by the laboratory are traceable to the International System of Units (SI).
1.1.5 Check whether the laboratory has a program and procedure for the calibration of its reference standards and that they are calibrated by a body that can provide such traceability.
1.1.6 Check whether such reference standards of measurement held by the laboratory are used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated.
1.1.7 Check whether in case of any adjustment these reference standards are calibrated before and after that adjustment.
1.1.8 Check that all external calibrations and verifications of measuring and test equipment, as well as of reference standards, have been conducted by either
I) a recognized National Metrology Institute (NMI) or Designated Institute (DI). Recognition of the NMI or DI is based on them being a signatory to the CIPM (Comité International des Poids et Mesures) MRA and having a corresponding entry in the CMC list of BIPM.. A listing of these recognized Institutes and their CMC entries can be found at the BIPM KCDB website at
http://kcdb.bipm.org/AppendixC/default.aspor
II) a calibration laboratory accredited to ISO / IEC 17025 by a mutually recognized Accreditation Body (http://ilac.org/signatory-search/); or
IIIa) An NMI whose service is suitable for the intended need but not covered by the CIPM MRA or
IIIb) A calibration laboratory whose service is suitable for the intended need but not covered by the ILAC Arrangement or by Regional Arrangements recognized by ILAC.
Routes IIIa) and IIIb) are only allowed if routes I and II are not possible or available for a particular calibration. An exception is route IIIa) for an NMI accredited by an ILAC-recognized Accreditation Body, since this is equivalent to route I).
In case I)
· Check that the NMI or DI certificate or report either displays the CIPM MRA logo or identifies the NMI or DI by other acceptable means as a CIPM MRA signatory and
· Check that the measurement results areconsistent with the NMI or DI CMC entries in the BIPM KCDB database.
In case II)
· check that the laboratory certificate or report either displays the logo of the Accreditation Body or identifies the Accreditation Body by other acceptable means and
· check that the measurement results areconsistent with the laboratory’s Scope of Accreditation issued by that Accreditation Body.
In case IIIa)
· check that routes I and II are not possible or available and
· Check that the calibration by the NMI or DI is provided on ENAO’s own scope of accreditation for that NMI or DI (after recognition of ENAO by ILAC) or on the scope of accreditation of another ILAC-recognized accreditation body. For an accredited NMI or DI, this policy is equivalent to the policy for case II). Otherwise,
· Proceed as per the second bullet point in case IIIb).
In case IIIb)
· check that routes I and II are not possible or available and
· check that, in this case, the calibration laboratory has been at least assessed for evidence of its technical competence, either by ENAO (after recognition by ILAC) or by another ILAC-recognized accreditation body, for the aspects listed below and found to conform with the requirements of ISO / IEC 17025 for these:
v Records of calibration method validation
v Procedures for estimation of uncertainty
v Documentation for traceability of measurements
v Documentation for assuring the quality of calibration results
v Documentation for competence of staff
v Documentation for accommodation and environmental conditions
v Audits of the calibration laboratory
1.2) If direct traceability to SI units is not possible or practical:
1.2.1 Evaluate and check that approaches I, II and III are not possible or practical (laboratory to provide the evidence).
1.2.2 If this proves to be the case, then evaluate and check that the calibration providesthe required confidence in these measurements by establishing traceability to appropriate measurement standards such as
- the use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterization of a material;
- the use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned.
1.2.3 Check whether the laboratory has participated in a suitable program of inter-laboratory comparisons, and, if not,
1.2.4 check whether the laboratory can provide evidence that this was not possible.
1.2.5 Check whether the laboratory has chosen a way to satisfy clause 5.6.2.1.2 of ISO/IEC 17015:2005 and has documented evidence for this, which is acceptable to ENAO.
With respect to Reference Materials (RMs),
1.2.6 check that these are, where possible, traceable to SI units of measurement, or to recognized Certified Reference Materials (CRMs).
The following CRMs are recognized by ILAC for the purpose of proving traceability:
a) CRMs produced by NMIs or DIs, whose measurement services for the material are listed in the BIPM KCDB database
http://kcdb.bipm.org/AppendixC/default.asp
and
b) CRMs covered by entries in the “Database on Laboratory Medicine and In Vitro Diagnostics” of the Joint Committee on Laboratory Medicine (JCTLM) http://www.bipm.org/jctlm/
c) CRMs produced by an accredited Reference Material Provider (RMP) under its scope of accreditation to ISO Guide 34:2009 (see policy 7, ILAC-P10:01/2013, page 9).
The majority of RMs and CRMs are produced by other RMPs.
1.2.7 For such RMs and CRMs, check that the laboratory can demonstrate that they are suitable for their intended use as required by clause 4.6.2 in ISO/IEC 17025:2005 (calibration laboratories.
1.3) Use of in-house calibrations
For all in-house calibrations, a calibration laboratory is required to maintain as a minimum the following:
1.3.1 a documented and validated calibration procedure or method (check);
1.3.2 a calibration certificate or report, or some other suitable method of recording the calibration and measurement data (check);
1.3.3 appropriate educational and training records to demonstrate the competence of the personnel performing the calibration (check);
1.3.4 copies of certificates and reports to demonstrate traceability(check);
1.3.5 all reference standards and measuring instruments shall be calibrated at appropriate intervals, the facility shall have and apply a documented procedure for establishing these calibration intervals (check);
1.3.6 a documented procedure for the estimation of the measurement uncertainty, which shall be applied for at least each type of calibration. The uncertainty of measurement shall be taken into account when making a statement of compliance (check);
1.3.7 records to demonstrate the assurance of the calibration results i.e. participation in Inter-Laboratory Comparisons or Proficiency Testing (check);
1.3.8 documented requirements for environmental conditions, and records where applicable (check); and
1.3.9 evidence of internal audits of all activities that could influence the quality of calibration results (check).
2) TESTING AND MEDICAL LABORATORIES ASSESSED UNDER
THE ILAC ARRANGEMENT ON TESTING
2.1 Check whether the calibration of instruments used in the testing laboratory under ISO/IEC 17025:2005 or the medical laboratory under ISO 15189:2012 contributes significantly (≥ 5%) to the overall test uncertainty. In that case the same policy for traceability applies as for calibration laboratories (section 1.1 above).
2.2 If not, check whether the laboratory has quantitative evidence to demonstrate that the associated contribution of a calibration contributes little (< 5%) to the measurement result and the measurement uncertainty of the test. In that case, traceability does not have to be demonstrated.
2.3 Under ISO/IEC 17025:2005, clause 5.6.2.2.2, check whether the laboratory can demonstrate that the traceability of measurements to SI units is not possible and / or relevant. In that case, the same requirements for traceability to certified reference materials, agreed methods and / or consensus standards are applicable as for calibration laboratories (section 1.2 above).
2.4 Under ISO 15189:2012, clause 5.3.1.4, check whether the following requirements for traceability are met:
The laboratory shall have a documented procedure for the calibration of equipment that directly or indirectly affects examination results. This procedure includes:
a) taking into account conditions of use and the manufacturer’s instructions;
b) recording the metrological traceability of the calibration standard and the traceable calibration of the item of equipment;
c) verifying the required measurement accuracy and the functioning of the measuring system at defined intervals;
d) recording the calibration status and date of recalibration;
e) ensuring that, where calibration gives rise to a set of correction factors, the previous calibration factors are correctly updated;
f) safeguards to prevent adjustments or tampering that might invalidate examination results.
Metrological traceability shall be to a reference material or reference procedure of the higher metrological order available.
NOTE Documentation of calibration traceability to a higher order reference material or reference procedure maybe provided by an examination system manufacturer. Such documentation is acceptable as long as the manufacturer’s examination system and calibration procedures are used without modification.
Where this is not possible or relevant, other means for providing confidence in the results shall be applied,including but not limited to the following:
— use of certified reference materials;
— examination or calibration by another procedure;
— mutual consent standards or methods which are clearly established, specified, characterized and mutually agreed upon by all parties concerned.
In this case as well, the same requirements for traceability to certified reference materials, agreed methods and / or consensus standards are required as for calibration laboratories (section 1.2 above).
3) UNCERTAINTY OF MEASUREMENT
a) Establish according to which well documented directives, guidelines and procedures (including own procedures),which shall be consistent with the latest version of the “Guide to the Uncertainty of Measurement” (GUM), issued jointly by ISO / IEC / BIPM / OIML, measurement uncertainty is calculated by the laboratory
b) The estimation of the measurement uncertainty is referred to as the “UNCERTAINTY BUDGET”. Note whether the laboratory uses a paper-based system or spreadsheets to carry out the often quite involved calculations for this uncertainty budget.
c) Check whether measurement uncertainties are reported as an expanded uncertainty with a defined coverage factor k (typically k = 2) and confidence interval (typically chosen to approximate the 95% confidence level).
Establish whether the laboratory is making statements about compliance with specifications in any of its certificates or reports. In case it does, evaluate whether the statements are consistent with the measured values as well as with the expanded uncertainties of these values. For chemical analysis see, for example, “Use of uncertainty information in compliance assessment” (EURACHEM, first edition, 2007). For electronics and engineering measurement see, for example, ASME B89.7.3.1-2001.
N.B This Checklist has to be done according to the flow chart which is addressed in the Policy of traceability of measurement results (PM 8.2/A) Annex A.
Signature of Assessor ______
Rev 3, 09 November 2016 Page 1 of 9