Medical Laboratory
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
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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 |
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MSA-02 | SNAS logo and marks | 07/24 |
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MSA-04 | Procedure for the accreditation | 05/24 |
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MSA-05 | Requirements for SNAS assessors and professional experts | 09/24 |
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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) | 05/24 | 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 | 07/24 |
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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 |
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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 | 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 | 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 |
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TL 238 | Checklist for testing, calibration and medical laboratories with FLEXIBLE SCOPE | 08/24 |
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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-mail: jana.paskova(@)snas.sk; mobil: + 421 910 931 631