ESYD ACCREDITATION CRITERIA AND GUIDELINES ESYD CAC/03/01/02-11-2015 1/8
ESYD CAC Issue: 03 Revision: 01 Issue Date: 30-04-2002 Revision Date: 02-11-2015 Prepared by: Quality Manager of ESYD Approved by: Head of ESYD Quality Manager of ESYD Head of ESYD ESYD CAC/03/01/02-11-2015 2/8
PART 1 Criteria and Guidelines for Laboratories and PT Schemes Providers accredited by the Hellenic Accreditation System No. Type of Organization Criterion ΕΑ / ILAC Guidelines Other Guidelines 1 Testing / Calibration Laboratories ΕLΟΤ ΕΝ ISO/IEC 17025:2005 ESYD RA EA : 2/13, 2/14, 2/15, 2/17, 3/01, 3/04, 4/02, 4/09, 4/14.4/15,4/16, 1.GA1 2.GA2 4/18 3.ESYD PDI WADA ISL (έλεγχος doping) ILAC: G8,G18,G19,G21,G24, P9,P10,P13,P14. 4.G-GMO 5.G-DEIGM EURACHEM Guidance on 6.G-FYTOPROST For testing laboratories for stationary source emissions ELOT CEN TS 15675:2007 is applied (application of ΕLOT ΕΝ ISΟ/ΙΕC 17025:2005 for the specific technical field) Accreditation of Microbiological Laboratories 7.G-MICROBIOL 8.G-AIOLIKO 9.G-METALLA 10.Memorandum for the accreditation of laboratories performing determination of human drugs and pesticides residues in flexible accreditation scope 11.G-APAER 12. G-NDT 13. G-FLEX 14 G- EVEL 15. ESYD PMULTISITE ESYD CAC/03/01/02-11-2015 3/8
2 Medical Laboratories ΕLΟΤ ΕΝ ISO 15189:2007 ΕLΟΤ ΕΝ ISO 15189:2012 ESYD RA ΕΑ: 2/13,3/01,3/04,4/07,4/14, 4/17, ILAC: G18, G21, G26, P9, P10 1.GA1 2.GA2 3.ESYD PDI 4.G-KLINERG 5.G- EVEL 6.ESYD PMULTISITE 3 PT Schemes Providers ELOT EN ISO/IEC 17043:2010 ESYD RA ΕΑ-2/09, 2/13, ILAC G21, P13 ESYD CAC/03/01/02-11-2015 4/8
PART 2 Criteria and Guidelines for Certification / Inspection / Verification bodies accredited by the Hellenic Accreditation System Α. General Criteria /Documents/ Guidelines No. Criteria /Documents/ Guidelines 1 ILAC G21:09/2012 Cross-Frontier Accreditation Principles for Cooperation 2 IAF MD 12:2013 Assessment of Certification Activities for Cross-Frontier Accreditation 3 IAF MD 7:2010 Harmonisation of Sanctions 4 IAF/ILAC A5:07/2012 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004 5 EA 2/13:2012 EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members 6 EA 2/13:2013 S1 interpretation of Terminology used in clause 5.1 of EA-2/13 7 EA-3/01 Μ:2012 EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status 9 Accreditation Regulations (ESYD RA ) 8 Accreditation Procedures (ESYD PA) 10 MD 6735/415/6-9-2010 (Β 1390), for the recognition and approval of certification/ inspection bodies in the regulatory sector 11 Guideline for the liability coverage of Certification/ Inspection Bodies - 30.6.2008. (Optional) 12 IAF ML 2:2011 General Principles on Use of the IAF MLA Mark ESYD CAC/03/01/02-11-2015 5/8
B. Specific Criteria /Documents/ Guidelines No. Type of Organization Criterion EA/IAF/ILAC Guidelines Other Guidelines 1 Inspection Bodies ΕLΟΤ ΕΝ ISO/IEC 17020:2012 1. EA-5/03:2008 2. EA-2/17:2014 1. G ADR 2. G ANEL 3. ILAC P10:01/2013 ILAC Policy on Traceability of Measure 3. G KTEO Results 4. G-D.P.&K 5. G-DIAKRIB 4. ILAC P15:06/2014 Application of ISO/IEC 17020:2012 6. G-PED for the Accreditation of Inspection Bodies 7. G-MACHINES 8. G-LIFTING 2 Product Certification Bodies ΕLΟΤ ΕΝ 45011:1998 ΕLΟΤ ΕΝ ISO/IEC 17065:2012 1. IAF GD 5:2006 2. EA-2/17: 2014 3. EA-3/12:2013 4. EA-6/02:2013 5. EA-6/04:2011 1. G ANEL 2. G-D.P.&K 3. G-EU ETS 4. G-DIAKRIB 5. G-PED 6. G-MACHINES 3 Management System ΕΛΟΤ ΕΝ ISO/IEC 17021:2011 1. IAF MD1:2007 1. G ANEL Certification Bodies ISO/IEC TS 17021-2:2012 (EMS) 2. IAF MD2:2007 2. G-22000 ISO/IEC TS 17021-3:2013 (QMS) ISO/IEC 27006:2011 (ISMS) ISO/TS 22003:2007 (FSMS) ISO 50003:2014 (Mandatory from 3. IAF MD3:2008 4. IAF MD4:2008 5. IAF MD5:2013 6. ΙΑF MD8:2015 (ISO 13485 mandatory from 8.1.2016) 3. G H&S 4. G-D.P.&K 5. G-PED 6. G-MACHINES 14.10.2017) 7. IAF MD9:2015 (ISO 13485 mandatory from 8.1.2016) ELOT TS 1432:2008 8. IAF MD10:2013 (Managerial Capability of 9. IAF MD11:2013 Organizations) 10. IAF MD15:2014 ( mandatory from 14.7.2016) ESYD CAC/03/01/02-11-2015 6/8
11. IAF MD16:2014 (FSMS, mandatory from 15.12.2016) 12. IAF MD17:2015 (QMS, EMS, mandatory from 7.1.2018) 13. IAF MD18:2015 (ISO/IEC 20000-1) 14. EA-2/17: 2014 15. EA-3/11:2009 16. EA-6/02:2013 17. EA-7/04:2010 4 Persons Certification Bodies ΕLΟΤ ΕΝ ISO/IEC17024:2003 ΕLΟΤ ΕΝ ISO/IEC17024:2012 1. IAF GD 24:2009 G-SXHPROS 5 EMAS Verifiers ΕLΟΤ ΕΝ ISO/IEC 17021:2011 Regulation (ΕU )No.1221/2009 1. ISO/IEC TS 17021-2:2012 (EMS) 2. IAF MD5:2013 3. IAF MD10:2013 4. IAF MD17:2015 (QMS, EMS, mandatory from 7.1.2018) 5. COMMISSION DECISION (2013/131/EU) / EMAS USER S GUIDE 1. ESYD DDPE 2. ESYD PVERIF 3. ESYD PSFEV GHG Verifiers ΕLΟΤ ΕΝ ISO/IEC 14065:2013 Regulation (ΕU )No. 600/2012 1. ISO 14064-3:2006 (VB GHG) 2. IAF MD 6:2014 3. IAF MD 14:2014 4. EA-6/03:2013 (EU ETS) 1. GD-GHG 2. EU Guidelines: European Commission / Directorate General / CLIMATE ACTION ESYD CAC/03/01/02-11-2015 7/8
Note: The EA Mandatory Documents are available in EA website: http://www.european-accreditation.org/publications The documents IAF MD are available in IAF website: http://www.iaf.nu/articles/mandatory_documents_/38 The ILAC Mandatory documents are available in ILAC website: http://ilac.org/publications-and-resources ESYD CAC/03/01/02-11-2015 8/8