RENAR Accreditation Activities
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- Liliana Carroll
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1 RENAR accreditation activities represent the scopes where RENAR has competence to provide accreditation services. RENAR defined its accreditation activities in accordance with the EA MLA scope (EA multilateral arrangement). EA MLA is an arrangement between full members of EA which recognize and accept the equivalence of the accreditation systems operated by signatories and confidence in the results of conformity assessment (e.g. a report or certificate) provided by accredited CABs by signatories of the relevant scope and divided into 5 levels, according to EA1/06: EA MLA Defining Standards, activities and explanations Level 1. Requirements for Accreditation Bodies The requirements in EN ISO/IEC 17011, in Regulation (EC) 765/2008 and, when applicable, the supplementary requirements defined in EA mandatory documents and in IAF and/or ILAC documents endorsed by EA as mandatory. 2. Conformity assessment activities of conformity assessment bodies to which accreditation bodies grants accreditation against standards included in Level 3 (a) Calibration (b) Testing (including medical analysis) (c) Inspection (d) Product Certification (hereinafter conformity assessment (e) Management System Certification activities) (f) Certification of persons (g) Verification 3. Harmonized standards (or other normative documents) which contain general requirements for conformity assessment bodies carrying out conformity assessment activities included on level 2 (hereinafter standards compliance assessment) 4. Documents containing criteria supplementary to those contained in Level 3 standards. Such documents are: (h) Proficiency testing providers (a) EN ISO/IEC (b)1 EN ISO/IEC (b)2 EN ISO (c) EN ISO/IEC (d) EN ISO/IEC (e) EN ISO/IEC (f) EN ISO/IEC (g) EN ISO (h) EN ISO/IEC RENAR : Annex 2MM01 Edition of Page. 1/7
2 EA MLA Level Defining (i) Sector specific standards or other recognisable normative documents (hereafter Sector standards); (ii) Sectoral schemes as specified in Regulation (EC) 765/2008 Articles 2(10) and 13; (iii) Conformity assessment schemes according to EA1/22 (hereafter Schemes) Note: Level 4 is only applicable where documents supplementing Level 3 standards exist (meaning that a Level 5 is often directly connected to a Level 3 standard). 5. Scope of accreditation: standards or other normative documents used by the accredited conformity assessment body to deliver an accredited conformity assessment field Standards, activities and explanations Examples of sectoral standards: ISO (a); CEN / TS (b) 1; ISO (b) 2; ISO / TS (e); ISO / IEC (e). Examples of sectoral schemes: Commission Regulation (EU) 600/2012 of GHG verifiers. Note: Can include, for example, test methods and specific management systems requirements (eg ISO 9001, ISO 14001). Scope of accreditation (level 5) for which the CAB may request accreditation RENAR are mentioned in the specific rules for accreditation (series documents RS) of each scheme. Note: Where are specified normative acts (regulations, directives, GD etc.), the subsequent modifications and amendments of these are taken into account. RENAR : Annex 2MM01 Edition of Page. 2/7
3 1. Calibration (level 2) Conformity assessment standard: SR EN ISO/CEI 17025:2005 (level 3) Scheme CAB Sectorspecific schemes and standards (Level 4): 1.1 LE Calibration laboratory 2. Testing (without medical tests) (level 2) Conformity assessment standard: SR EN ISO/CEI 17025:2005 (level3) Scheme CAB Sectorspecific schemes and standards (level 4): LI Testing laboratory LI Testing laboratory WADA antidopping LI Testing laboratory SR CEN/TS 15675:2009 stationary source emissions 7.16 ON Notified body Reg. (UE) 305/ ON Notified body Government Decision (GD) 74/ (2009/48/CE Directive on toys saftey) 3. Testing: medical test (level 2) Conformity assessment standard: SR EN ISO 15189:2013 (level 3) Scheme CAB Sectorspecific schemes and standards (level 4): 1.3 LM Medical analysis laboratory 1.4 LR Medical laboratory Radiology and medical imaging RENAR : Annex 2MM01 Edition of Page. 3/7
4 4. Proficiency testing (level 2) Conformity assessment standard: SR EN ISO/CEI 17043:2010 (level 3) Scheme CAB Sectorspecific schemes and standards (level 4): 2 IC Proficiency testing providers 5. Inspection (level 2) Conformity assessment standard: SR EN ISO/CEI 17020:2012 (level 3) Scheme CAB Sectorspecific schemes and standards (level 4): 3 OI Inspection body 7.17 ON Notified body GEO 126/2011 (Directive 2010/35 / EU Transportable Pressure Equipment) 7.18 ON Notified body GD 74 / (Directive 2009/48 / EC on the safety of toys) 10 OT Designated body European Agreement concerning the international road transport of dangerous goods (ADR) 6. Product Certification (level 2) Conformity assessment standard: SR EN ISO/CEI 17065:2013 (level 3) Scheme CAB Sectorspecific schemes and standards (level 4): 4 PR Certification products, processes and services body 7.2 ON Notified body GD 710/2015 (Directive 2014/31 / EU automatic weighing devices) 7.3 ON Notified body Reg. (UE) 425/ ON Notified body GD 1756/2006 (Directive 2000/14 / EC Noise) 1 Until the completion of transition is also considered GD 115/2004 (Directive 89/686 / EEC Personal Protective Equipment) RENAR : Annex 2MM01 Edition of Page. 4/7
5 Scheme CAB Sectorspecific schemes and standards (level 4): 7.5 ON Notified body GD 1029/2008 (Directive 2006/42 / EC Machinery) 7.6 ON Notified body GD 711/2015 (Directive 2014/32 / EU Measuring Instruments) 7.7 ON Notified body GD 410/2016 (Directive 2014/33 / EU Elevators) 7.8 ON Notified body GD 245/2016 (Directive 2014/34 / EU equipment in explosive atmospheres) 7.9 ON Notified body GD 1102/2014 (Directive 2013/29 / EU Pyrotechnic wares ) 7.10 ON Notified body GD 197/2016 (Directive 2014/28 / EU Explosives for civil purposes) 7.11 ON Notified body GD 123/2015 (Directive 2014/68 / EU Pressure Equipment) 7.12 ON Notified body GD 824/2015 (Directive 2014/29 / EU Simple pressure vessels) 7.13 ON Notified body GD 574/2005 (Directive 92/42 / EEC Hot water boilers) 7.14 ON Notified body Reg. (UE) 426/ ON Notified body Reg. (UE) 305/ ON Notified body GD. 74 / (Directive 2009/48 / EC on the safety of toys) 8.2 OR Recognized Inspection and Reg. (UE) 1151/2012 certification body 8.3 OR Approved Inspection and Reg. (CE) 834/2007 certification body 8.5 OR Recognized Certification Reg. (CE) 110/2008 Body 10 OT Designated body European Agreement concerning the international road transport of dangerous goods (ADR) 7. Certification of Management Systems (level 2) Conformity assessment standard: SR EN ISO/CEI :2015 (level 3) Scheme CAB Sectorspecific schemes and standards (Level 4): and Standards or other normative documents used by accredited CABs or private certification scheme (Level 5): 5.2 SM SR ISO/CEI TS : SMC SR EN ISO 9001: Până la finalizarea tranzitiei se ia în considerare şi HG 775/2011 (Directiva 2009/142/CE Aparate consumatoare de combustibili gazoși) RENAR : Annex 2MM01 Edition of Page. 5/7
6 Scheme CAB Management systems certification bodies 5.3 SMFS Certification body for food safety management systems FSSC Sectorspecific schemes and standards (Level 4): and Standards or other normative documents used by accredited CABs or private certification scheme (Level 5): SR ISO/CEI TS : SMM SR EN ISO 14001: SMMD SR EN ISO 13485: SMOH SR OHSAS 18001:2008 SR ISO 50003: SMEN SR EN ISO 50001:2011 SR ISO/IEC 27006: SMSI SR ISO/CEI 27001:2013 SR ISO/TS 22003: SR EN ISO 22000:2005 FSSC SR ISO/TS 22003:2016 and requirements of the scheme 7.2 ON Notified body GD 710/2015 (Directiva 2014/31/UE Aparate de cântărit cu funcționare neautomată) SR EN ISO 22000:2005 and requirements of the scheme 7.4 ON Notified body GD 1756/2006 (Directive 2000/14 / EC Noise) 7.5 ON Notified body GD 1029/2008 (Directive 2006/42 / EC Machinery) 7.6 ON Notified body GD 711/2015 (Directive 2014/32 / EU Measuring Instruments) 7.7 ON Notified body GD 410/2016 (Directive 2014/33 / EU Elevators) 7.16 ON Notified body Reg. (UE) 305/ OR Certification body Reg. (UE) 333/ OR Environmental verifier Reg. (CE) 1221/2009 EMAS 8. Certification of persons (leve 2) Conformity assessment standard: SR EN ISO/CEI 17024:2012 (level 3) Scheme CAB Sectorspecific schemes and standards (Level 4): RENAR : Annex 2MM01 Edition of Page. 6/7
7 6 PS Personnel certification bodies 7.11 ON Notified body GD 123/2015 (Directive 2014/68 / EU Pressure Equipment) 9. Verification (level 2) Conformity assessment standard: SR EN ISO 14065:2013 (level 3) Scheme CAB Sectorspecific schemes and standards (Level 4): 9 OV Verification bodies for emission of greenhouse gases Reg. (UE) 600/2012 RENAR : Annex 2MM01 Edition of Page. 7/7
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