Announcement for accredited testing, calibration and medical laboratory.

Slovak National Accreditation Service would like to inform you about the expansion of the functionality of the Accreditation Information System (AIS) by part PT - Interlaboratory comparison.

Calibration, testing and medical laboratories are obliged to insert the current version of the implementation strategy for participation in proficiency testing (PT) and interlaboratory comparisons (ILC) in the completed TL 71 form before each assessment in AIS, in the section Documentation, PT/annual analyses.

Since 2001, SNAS has been a signatory of EA MLA and ILAC MRA in the field of testing laboratories. In accordance with EA and ILAC policies, SNAS uses accreditation activities to ensure continuous fulfillment of all requirements arising from the relevant accreditation scheme EN ISO/IEC 17025: 2017. In the field of accreditation of testing laboratories, more than 200 testing laboratories are accredited, including in unique areas of testing, which cover the environment, food, veterinary testing, working environment, various technical laboratories including technical purity of materials, weapons, pyrotechnics, explosives, forensics, emissions, exhaust, automotive materials and vehicle homologation. Testing laboratories are accredited in both regulated and non-regulated areas. In the regulated area, SNAS cooperates with national regulators for various areas of testing with ÚNMS SR, the State Building Office and the State Transport Office of the MDaV SR. Attestation of the fulfillment of notification requirements is in cooperation with the MŽP SR.

The application for the accreditation service is submitted only through the AIS accreditation information system.

Registration in AIS is required before submitting the first application for accreditation.

When filling out the application for the accreditation service for testing laboratories, it is necessary to insert the completed Annex OA 2, which contains both forms OA and TL606.

In the case of a change in accreditation of a formal nature according to point 7.1.7 of MSA-04 (e.g. formal modification in the area or scope of accreditation, change in normative documents, change in standard that doesn`t affect the method, inclusion of reported changes of flexible RA, modification of RA resulting from requirements regulator, modification of RA resulting from requirements of mandatory documents EA, ILAC, IAF, other modifications that don`t affect the relevant determining data, etc.), it`s necessary to submit an application on the form TL 607 Application for change of accreditation of a formal nature.

In connection with the implementation of the information system project, the result of which should be the simplification and transparency of the entire accreditation process, the Slovak National Accreditation Service prepared list of determining data for individual areas of accreditation.

Defining the determining data describing the activity of testing and medical laboratories is based on the combination of the subject/matrix and the test (principle of determination). The expertise of SNAS assessors and experts involved in accreditation services is defined in the same way. The goal is to achieve the compatibility of the database of assessors and accredited laboratory activities, ensuring the correct selection of assessment group members, reducing the administrative burden, as well as speeding up and simplifying the entire assessment process. The result is the attached "activities catalog". Categorization of laboratory activities based on this "catalogue" will help as a basis for the compilation of assessment groups.

Measurement results of laboratories that want to be accredited or are accredited must be treceable in an acceptable way in accordance with the requirements of Art. 6.5 of the ISO/IEC 17025:2017 standard.

SNAS has elaborated policy PL - 13: SNAS Policy on metrological traceability of measurement results.

To make it easier to choose a suitable place to ensure treceabiity, we provide the following information:

• In the case of the measurement results treceability to the Slovak Metrological Institute or foreign metrological institutes, it`s necessary to check whether the relevant metrological institute is a signatory to the Convention on the Recognition of Standards and Certificates Issued by the Institute (signatories, convention), and whether it has in the CMC (Calibration and measurement capability) tables, published data in the given area to the extent that the laboratory requires its continuity of measurements.

The fulfillment of these conditions in terms of the Convention of BIPM, OIML and ILAC is recognized as an acceptable treceability of measurement results.

• In case of treceability of measurements with an accredited laboratory, it is necessary for the laboratory to choose a suitable place in the database of published accredited laboratories of the relevant national or foreign accreditation body, which is a signatory of the EA-MLA Mutual Recognition Agreement or ILAC-MRA. Measurement treceability of the laboratory is acceptably ensured if the selected entity provides treceability services in the measurement range and with the uncertainty required by the laboratory or needs for its measurements or calibrations. The obtained uncertainty of the results of the relevant calibration from the entity providing treceability services is only one component in the balance of the uncertainty of the result of measurement, testing or calibration in the laboratory.
• There are calibrations or measurements in testing, for the results of which it is not possible to ensure treceability strictly to SI units. In these cases, the credibility of the measurement must be ensured by creating treceability in the following way:
• using certified reference materials from competent supplier who is able to provide their reliable physical or chemical characteristics;
• using specified methods and/or agreed templates that are clearly described and agreed upon by the parties involved;
• laboratory participation in appropriate interlaboratory comparisons is required when possible.

The above principles also apply to the use of reference materials, as these have the attribute of a standard.

In case of confusion in the area of ensuring continuity, in specific cases, the accreditation body can be contacted directly.

SNAS assessors must follow the above-mentioned principles when assessing compliance with the requirements for ensuring treceability in calibration and testing laboratories.

SNAS assesses the fulfillment of requirements of the standards ISO/IEC 17025 for testing and calibration laboratories, ISO 15189 for medical laboratories and these standards require that laboratories shall have a system for assurance of quality of test and/or calibration results and medical examination within this system they participate in proficiency testing (external quality assessment) or in other interlaboratory comparisons. Proficiency tests and interlaboratory comparisons are an important tool for monitoring of laboratory performance. SNAS considers the participation of laboratories in the PT and ILC programs as an important part of demonstrating the fulfillment of the accreditation criteria of accredited laboratories.

SNAS requires the active participation of laboratories in PT/ILC programs organized in Slovakia or at the international level in accordance with the relevant EA and SNAS regulations. The participation of laboratories in PT and ILC is governed by the SNAS policy for participation in proficiency tests PL-23 and the methodological guideline for determination of the level and frequency of the participation in proficiency testing MSA-L/14.

If PT/ILC is not available (practicable), the laboratory must ensure quality control by other adequate procedures (MSA-L/14 and PL23).

Calibration, testing and medical laboratories are obliged to insert the current version of the implementation of the participation strategy in PT /ILC in the completed relevant form TL 71 before each assessment into AIS, in the section Documentation, PT/annual analyses.

Profeciency testing providers accredited SNAS

Link to EPTIS

Selected competent Profeciency testing providers

Contact the NAB of neighboring countries with Slovak Republic the accreditation scheme accoridng to ISO/IEC 17043 Profeciency testing providers

Ing. Janka Szabová; e-mail: janka.szabova(@)snas.sk; mobil: 0949 008 249

Ing. Henrieta Bóriková; e-mail: henrieta.borikova(@)snas.sk; mobil: 0940 982 186