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.

Electronic services for providing accreditation services

Slovak National Accreditation Services has launched electronical services for providing accreditation services. All processes, including  filling in the applications for providing accreditation services, its course, procesing results from testing of whole service, are solved electronically - directly by Accreditation information system - AIS.

It is necessary to have internet connection and web browser for AIS usage. Access to AIS is possible anytime on website AIS

New applicants for accreditation have to fill the registration form for their legal entity on website AIS

Application for accreditation services can be submit only through AIS. 

More information about working in AIS you can find in the User's Guide for the Subject, accessible after logging into the system by clicking on the name of the logged-in user at the top right of the screen.

Annex OA 3: Medical Laboratory

Title Size Document
Annex OA 3: Medical Laboratory 118.58 KB
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Methodical Guidelines for Accreditation - Medical Laboratory

Identification Title Valid from File Extra Note
MSA-02 SNAS logo and marks 02/24
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MSA-04 Procedure for the accreditation 02/24
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MSA-05 Requirements for SNAS assessors and professional experts 05/24
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MSA-06 Responsibilities of SNAS and conformity assessment bodies 02/24
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MSA-07 EA requirements for the accreditation of flexible scopes (EA-2/15) 02/20 info
MSA-08 IAF Mandatory document for the use of information and communication technology (ICT) for auditing/assessment purposes (IAF MD 4: 2018) 02/22 info
MSA-L/01 Field and scope of accreditation of laboratories field and proficiency testing providers 12/23
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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 07/21
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effective from 07.2021
MSA-N/01 EA Document on Accreditation for Notification Purposes 04/22 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 07/19
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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 06/21
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PL-06 SNAS Policy on Cooperation with Interested Parties 09/18
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PL-07 SNAS Policy on Accreditation of Laboratories 05/21
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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 08/21
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PL-13 SNAS Policy in the Field of Traceability of Measurements 12/20
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PL-16 SNAS Policy on Protection and Use of SNAS Logo, Accreditation and Combined Mark of Accredited Body 03/20
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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: 2020) 12/20 info
PL-21 SNAS policy for accreditation of flexible scope 05/22
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PL-23 SNAS Policy on Participation in Proficiency Testing 05/22
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PL-25 SNAS Policy for Subcontracting 07/21
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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 09/22
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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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Forms

Identification Title Valid from File Extra Note
TL 238 Checklist for testing, calibration and medical laboratories with FLEXIBLE SCOPE 03/21
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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.

National accreditation bodies, neighboring countries with the Slovak Republic, with the accreditation scheme according to ISO/IEC 17043 for PT providers

Proficiency testing (PT) provider accredited by SNAS

Current International Projects for Proficiency Testing (PT) and Interlaboratory Comparisions (ILC) - for Testing, Examining and Calibration

A list of selected competent PT providers can be found on the page: Proficiency Testing

EPTIS database

Technical guarantor for medical laboratories

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

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