medical laboratories

Announcements for medical laboratories

The outcome of the meeting of the Technical Committee ML/2024/1 – Pathology Department in spring 2024 is the approval of the nomenclature for biological material and analyte used within the scope of accreditation for cytological and biopsy laboratories. The document contains (please see Slovak version of website) a detailed explanation of each type of biological material and at the same time a precise description of a specific analysis in a given investigation area.

In the autumn 2025, the technical committee ML/2025/1 met, in which the draft scope of accreditation for the field of cytogenetics was approved. The output is an informative overview for cytogenetic laboratories, presented in the document - please see Slovak versiom of website.

Accreditation of medical laboratories

SNAS has been a signatory of EA MLA and ILAC MRA in the field of accreditaion of medical laboratories since 2001. In accordance with EA and ILAC policies, SNAS provides accreditation activities to ensure permanent fulfillment of all requirements resulting from the relevant accreditation scheme ISO 15189. In the field of medical laboratory accreditation, medical laboratories are currently accredited by SNAS in the areas of: clinical biochemistry, clinical hematology and transfusion, clinical microbiology, medical genetics and clinical pathology.

Application for accreditation of medical laboratories

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

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 3.

Annex OA 3: Medical Laboratory

Title Size Document
Annex OA 3: Medical Laboratory 118.58 KB
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Submission of application for change of accreditation of formal nature

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.

Title Size Document
TL-607: Application for change of accreditation of a formal nature 36.83 KB
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Methodical Guidelines for Accreditation - Medical Laboratory

Identification Title Valid from File Extra Note
MSA-02 SNAS logo and marks 11/24
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MSA-04 Procedure for the accreditation 12/24
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MSA-05 Requirements for SNAS assessors and professional experts 07/25
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MSA-06 Responsibilities of SNAS and conformity assessment bodies 05/24
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MSA-07 EA requirements for the accreditation of flexible scopes (EA-2/15) 05/24 info
MSA-08 IAF Mandatory document for the use of information and communication technology (ICT) for auditing/assessment purposes (IAF MD 4: 2025) 04/25 info
MSA-10 Harmonization of sanctions and addressing fraudulent behavior 02/24 info
MSA-L/01 Field and scope of accreditation of laboratories field and proficiency testing providers 11/25
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MSA -L/04 Guidelines on the reporting of compliance with specification (ILAC-G8: 03/2009) 11/20 info (effectiveness of the Slovak translation)
MSA-L/14 Determination of the level and freqency of the participation in proficiency testing 02/25
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MSA-N/01 EA Document on Accreditation for Notification Purposes 02/25 only in Slovak version

Policies for Accreditation - Medical Laboratory

Identification Title Valid from File Extra Note
PL-01 SNAS Policy on Quality and Impartiality 02/24
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PL-02 Code of conduct for SNAS employee 05/25
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PL-03 SNAS Policy on Non-Discriminatory Access to Accreditation 05/20
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PL-04 EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members (EA-2/13 M:2019) 05/20 info
PL-05 SNAS Policy for the Implementation of Accreditation Schemes 12/24
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PL-06 SNAS Policy on Cooperation with Interested Parties 12/24
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PL-07 SNAS Policy on Accreditation of Laboratories 07/24
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PL-10 SNAS Policy on Accreditation for Authorisation/ notification Purposes 10/23
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PL-11 SNAS Policy Applied for Updating Standards Laying Down Testing and Calibration Methods in Accredited Entities 01/25
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PL-13 SNAS policy on the metrological traceability of measurement results 11/25
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PL-16 SNAS Policy on protection and use of SNAS logo, accreditation and combined mark of accredited body 04/25
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PL-18 EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA Accreditation Body Members (EA-1/22 A-AB: 2023 12/24 info
PL-21 SNAS policy for accreditation of flexible scope 05/24
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PL-23 SNAS Policy on Participation in Proficiency Testing 02/25
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PL-25 SNAS Policy for Subcontracting 08/25
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PL-54 SNAS POLICY AND PROCEDURE FOR THE ASSESSMENT OF CONFORMITY ASSESSMENT BODIES FOR NOTIFICATION PURPOSES IN ACCORDANCE WITH EA-2/17 M: 2020 05/25
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PL-58 The Policy and Procedure of SNAS for the Assessment of Laboratories According to the Requirements of the Standard ISO 15189: 2022 05/24
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Checklist for medical laboratories according to ISO 15189

Please see Slovak version of website: Checklist for medical laboratories according to ISO 15189

Forms

Identification Title Valid from File Extra Note
TL 71/C PT-ML 10/24
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TL 238 Checklist for testing, calibration and medical laboratories with FLEXIBLE SCOPE 08/24
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List of activities for testing and medical laboratories

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.

Profeciency testing and international comparison

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

European database of profeciency testing programs (EPTIS)

Selected competent Profeciency testing providers

Technical guarantor for medical laboratories

Ing. Jana Pašková; e-mailjana.paskova(@)snas.sk; mobil: + 421 910 931 631

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