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ISO/IEC 17025 and remote calibration: are they compatible ? Rainer Köhler Bureau International des Poids et Mesures (BIPM) Pavillon de Breteuil F-92312 Sevres, Cedex

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Nation 2

Nation 1

traceability

NMI primary standards

BIPM/RMO comparisons

NMI working standards

BIPM/RMO comparisons

NMI primary standards NMI working standards

Accredited calibration network

regional accreditation comparisons

Accredited calibration network

Accredited testing laboratory

regional accreditation proficiency tests

Accredited testing laboratory

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ISO/IEC 17025 : 4.1 The basics: The organization 4.1.2 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the customer

That fixes us to a framework

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ISO/IEC 17025 : 4.1 4.1.3 The management system shall cover work carried out in the laboratory’s permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.

How to interpret that ? In remote calibration there are two “permanent” facilities - does it mean both laboratories need to be accredited for the scope of the measurements ?

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ISO/IEC 17025 : 4.1 cont’d

Accreditation of the “remote” laboratory would solve a number of possible difficulties with the interpretation of ISO/IEC 17025 within the scope of remote calibration

but parts of the advantages of remote calibrations in such a scheme will be lost, e.g. financial (travel cost plus time - etc)

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Equipment transfer From my understanding (which may change during the workshop here today !) many e-trace measurements require at one point - maybe not too frequently, but necessarily regularly - the transfer of a reference standard (maybe even a primary standard) ISO/IEC 17025 is quite clear about equipment: 5.5.3 Equipment shall be operated by authorized personnel 5.5.9 When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked .... Bureau International des Poids et Mesures

Equipment transfer

.... and that would mean that the « calibrator » cannot be used for calibrations again until its own next calibration !

In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.

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Equipment cont ’d .

5.5.7 Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service..

How do you know it has been mishandled ? How do you know it IS this instrument ?

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Personnel The laboratory shall • have managerial and technical personnel who (....) have the authority and resources needed to carry out their duties, (....), and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures .... Which personnel, the one on the remote computer, the one on site pushing the buttons or both ? Which of the two management systems ? Bureau International des Poids et Mesures

Data integrity Electronic transmission of results

5.10.7 In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met.

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Data integrity cont’d Data safety and data integrity: during the remote controlled calibration • does the instrument really measure what you asked for ? • are the values it sends really what it had measured ? Because of • (modification of the remote controlled equipment (viruses, installation of new software, ....) • « man in the middle »

Where resides the data acquisition, data analysis and certificate edition software ? Bureau International des Poids et Mesures

Personnel 5.2.1 The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. When using staff who are undergoing training, appropriate supervision shall be provided. .... 5.2.3 The laboratory shall use personnel who are employed by, or under contract to, the laboratory. (...) the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system. Bureau International des Poids et Mesures

Environment .

5.3.2 The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results.

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Other factors Control of correctness of subsidiary measurements ? - temperature, pressure, humidity Handling of equipment ? - shipping + reception

Just treat it like an accreditation ?

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Method validation .

5.4 Test and calibration methods and method validation (includes estimation of uncertainties)

There might be some specific problems due to the remote control part but nothing in contradiction to the ISO standard

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In brief .

The main questions are: Equipment transported and “out of sight” during its use Equipment used by (unknown) staff on the remote site Use of an environment for which you do not have control and all the parameters Data security and data integrity - for both, the control of the measurement, calculation of the results and delivery of the certificate Bureau International des Poids et Mesures

And finally .

Who (what) is “the laboratory”

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The solution ? ? ? ?

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