Confirmed by Viktor Krutob, Director of EAK 1(5) EAK ACCREDITATION REQUIREMENTS (rev 30 th December 2014)

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1 Confirmed by Viktor Krutob, Director of EAK 1(5) EAK ACCREDITATION REQUIREMENTS (rev 30 th December 2014) I LABORATORIES 1.1. The accreditation requirements for laboratories are set out in the standard EVS-EN ISO/IEC 17025:2006 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005). 1.2 The medical laboratory shall comply with EVS and/or standard EVS-EN ISO 15189:2012* Medical laboratories. Requirements for quality and competence (ISO 15189:2012). * Validity of accreditations granted against the requirements of standard EVS-EN ISO 15189:2008 will cease on at the latest. 1.3 In addition: the calibration laboratory shall follow the requirements of the guidance documents EA-4/02 Expressions of the Uncertainty of Measurements in Calibration and ILAC-P14 ILAC Policy for Uncertainty in Calibration and participate in intercalibration at least once before accreditation and at least once per 4 years after accreditation by each measurand belonging to its scope of accreditation; the testing laboratory shall follow the requirements of the guidance document EA-4/16 EA Guidelines on the expression of uncertainty in quantitative testing and participate (if applicable) in interlaboratory comparison or proficiency tests at least once before accreditation and at least once per 5 years after accreditation by each group of methods within its scope of accreditation based on the same measurement principle; the verification laboratory shall follow the requirements of the guidance document EAK J15 Specific accreditation requirements for measuring instruments verification laboratories and conformity assessment bodies and participate in intercalibration or verification at least once before accreditation and at least once in 2,5 years after accreditation by each measurand belonging to its scope of accreditation; the medical laboratory shall follow the requirements of the document EA-4/17 EA Position Paper on the description of scopes of accreditation of medical labortories. 1.4 Laboratories seeking a flexible scope of accreditation shall, in addition to what is stated in the cl above, comply with the requirements of the guidance document EAK J19 Flexible scope of accreditation. General principles and conduct of an assessment. 1.5 To comply with the accreditation requirements laboratories shall also follow the requirements of the guidance documents ILAC-P10 ILAC Policy on Traceability of Measurement Results, EAK J16 Traceability of measurements. General requirements and EAK J9 Conditions for the use

2 EAK accreditation requirements (cont.) 2(5) 1. Accreditation will be carried out according to the guidance document EAK J13 The conduct of a laboratory assessment. 2. The EAK guidances and translated EA guides are available from the EAK website at the address The EA documents are available from the EA website at the address and ILAC documents from Copies of the documents are available also from EAK. II INSPECTION BODIES 2.1 Accreditation requirements for the inspection bodies are set out in the standard EVS-EN ISO/IEC 17020:2012* Conformity assessment. Requirements for the operation of various types of bodies performing inspection. * Inspection bodies accredited before shall till comply with the requirements of the standard EVS-EN ISO/IEC 17020:2006 General criteria for the operation of various types of bodies performing inspection (ISO/IEC 17020:1998). 2.2 To comply with the accreditation requirements an inspection body shall also follow the requirements of the document ILAC-P15 Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies. 2.3 To ensure traceability and reliability of measurements carried out in the course of inspection, an inspection body shall follow the guidance documents ILAC-P10 ILAC Policy on Traceability of Measurement Results and EAK J16 Traceability of measurements. General requirements and participate (if applicable) in interlaboratory comparison or proficiency tests at least once before accreditation and at least once per 5 years after accreditation by each group of methods based on the same measurement principle. 2.4 When making reference to accreditation an inspection body shall follow III BODIES CERTIFYING PRODUCTS, PROCESSES AND SERVICES 3.1 The accreditation requirements for bodies certifying products, processes and services are set out in the standard EVS-EN ISO/IEC 17065:2012* Conformity assessment. Requirements for bodies certfying products, processes and services. * The certification bodies accredited before shall till comply with the requirements of the standard EVS-EN 45011:1999 General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996).

3 EAK accreditation requirements (cont.) 3(5) 3.2 To comply with the accreditation requirements a product certification body shall also follow the requirements of the document IAF GD 5 IAF Guidance on the Application of ISO/IEC Guide 65: Certification bodies operating certification of welding activities shall also comply with the requirements of the guidance document EA 6/02 EA Guidelines on the Use of EN and ISO/IEC for Certification to EN ISO When making reference to accreditation a certification body shall follow IV BODIES OPERATING CERTIFICATION OF PERSONS 4.1 The accreditation requirements for bodies operating certification of persons are set out in the standard EVS-EN ISO/IEC 17024:2012* Conformity assessment. General requirements for bodies operating certification of persons. * The certification bodies accredited before shall till comply with the requirements of the standard EVS-EN ISO/IEC 17024:2005 Conformity assessment. General requirements for bodies operating certification of persons (ISO/IEC 17024:2003). 4.2 To comply with the accreditation requirements a personnel certification body shall also follow the requirements of the document IAF GD 24 Guidance on the Application of ISO/IEC 17024: When making reference to accreditation a certification body shall follow V MANAGEMENT SYSTEMS CERTIFICATION BODIES 5.1 The accreditation requirements for management systems certification bodies are set out in the standard EVS-EN ISO/IEC 17021:2011 Conformity assessment. Requirements for bodies providing audit and certification of management systems. 5.2 To conform to the accreditation requirements a management systems certification body shall also follow the requirements of the following documents: IAF MD 1 IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling, IAF MD 2 IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems, IAF MD 5 IAF Mandatory Document for Duration of QMS and EMS Audits, IAF MD 10 Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021: 2011 and IAF MD 11 Application of ISO/IEC for Audits of Integrated Management Systems. 5.3 Certification bodies operating certification of welding activities shall also comply with the requirements of guidance document EA 6/02 EA

4 EAK accreditation requirements (cont.) 4(5) Guidelines on the Use of EN and ISO/IEC for Certification to EN ISO Bodies operating certification of environmental management systems shall also follow the requirements of the documents EA-7/04 Legal Compliance as a part of accredited ISO 14001:2004 certification and ISO/IEC TS Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 2: Competence requirements for auditing and certification of environmental management systems. 5.5 Food safety management systems certification bodies shall also comply with the requirements of ISO/TS 22003:2007 Food safety management systems. Requirements for bodies providing audit and certification of food safety management systems and EA-3/11 Food Safety Management Systems. Scope of Accreditation. 5.6 When making reference to accreditation a certification body shall follow 1. Accreditation of inspection and certification bodies will be carried out according to the guidance document EAK J17 The guide for assessment of a certification/inspection body. 2. The EAK guidances, application forms and translated EA guides are available from the EAK website at the address The EA documents are available from the EA website at the address and IAF documents at the address Copies of the documents are available also from EAK. VI ENVIRONMENTAL VERIFIERS 6.1 The environmental verifiers shall comply with requirements of the Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisation in a Community eco-management and audit scheme (EMAS). 6.2 Standard EVS-EN ISO/IEC 17021:2011 Conformity assessment. Requirements for bodies providing audit and certification of management systems provides guidelines for implementation of the above (cl. 6.1) requirements. 6.3 When making reference to accreditation the EMAS environmental verifiers shall follow the requirements of the guidance document EAK J9 "Conditions for the use of accreditation symbol and reference to accreditation and MLA signatory status by the EAK accredited laboratories and bodies. 1. Accreditation will be carried out according to the guidance document EAK J18 The conduct of an environmental verifier assessment.

5 EAK accreditation requirements (cont.) 5(5) 2. The EAK guidances are available from the EAK website the translated EC Regulations and guidances from the website of Ministry of Environment at the address /juhtimissysteemid. The EC documents are available at the address europa.eu.int/comm/environment/ emas/documents and IAF documents at the address Copies of the EA and EAK guidances are available also from EAK. VII GREENHOUSE GAS VERIFIERS 7.1 The greenhouse gas (GHG) verifiers shall comply with the requirements of the standard EVS-EN ISO 14065:2013 Greenhouse gases. Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition. 7.2 To conform to the accreditation criteria the GHG verifiers shall also follow the requirements of the standard EVS-ISO :2012 as well as the guidance documents EA-6/03:2013 EA Document for Recognition of Verifiers under the EU ETS Directive and IAF MD 6:2014 Application of ISO 14065: When making reference to accreditation a GHG verifier shall follow the requirements of the guidance document EAK J9 "Conditions for the use of accreditation symbol and reference to accreditation and MLA signatory 1. Accreditation of a verifier will be carried out according to the guidance documents EAK J17 and EAK J21 The conduct of assessment of a GHG verifier. 2. The EAK guidances and application forms are available from the EAK website at the address Copies of the documents can be obtained also from EAK. VIII PROFICIENCY TESTING (PT) PROVIDERS 8.1 The PT providers shall comply with the requirements of the standard EVS-EN ISO/IEC 17043:2010 Conformity assessment. General requirements for proficiency testing. 8.2 To conform to the accreditation requirements the PT providers shall also follow the guidance document EAK J16 Traceability of measurements. General requirements, if applicable. 8.3 When making reference to accreditation a PT provider shall follow the requirements of the guidance document EAK J9 "Conditions for the use of accreditation symbol and reference to accreditation and MLA signatory 1. Accreditation of a PT provider will be carried out according to the guidance document EAK J20 The conduct of assessment of a PT provider. 2. The EAK guidances and application forms are available at EAK website Copies of the documents can be obtained also from EAK.