GUIDANCE AND INTERPRETATION DOCUMENTS TO THE REQUIREMENTS FOR THE COMPETENCE OF CONFORMITY ASSESSMENT BODIES

Transcription

1 GUIDANCE AND INTERPRETATION DOCUMENTS TO THE REQUIREMENTS FOR THE COMPETENCE OF CONFORMITY ASSESSMENT BODIES Table of Contents 1 PURPOSE GENERAL GUIDANCE AND INTERPRETATIVE DOCUMENTS All types of bodies Laboratories Inspection bodies Certification bodies Environmental verifiers Assessment of verifiers of greenhouse gas emission reports Accreditation for notification purposes CHANGES SINCE THE PREVIOUS REVISION OF THE DOCUMENT TRANSITORY AND FINAL PROVISIONS CONTROL OF THE DOCUMENT... 5 Revision 13 In use as of: Page 1 of 5

2 1 PURPOSE This document is intended for clients and accreditation procedure operators to inform them about interpretation documents concerning the criteria applied by SA when assessing the competence of conformity assessment bodies. 2 GENERAL The criteria are laid down in the S03 document, which also specifies the requirement that, in addition to these criteria, the relevant guidance and interpretation documents should also be used. 3 GUIDANCE AND INTERPRETATIVE DOCUMENTS This document covers guidance papers of ILAC, IAF, EA, EURACHEM, EUROLAB and EU as well as interpretation documents adopted by the SA Accreditation Committee. SA uses the latest revision of these documents published on the website of the publisher. When performing assessments, not only the guidance and interpretation documents listed below, but also other guidance and interpretation documents specific to particular fields of work of the respective accredited bodies (e.g., documents of professional associations) shall be used. The guidance used to interpret the requirements for testing and calibration laboratories shall also be used in the accreditation procedures of inspection and certification bodies, i.e., in those cases where inspection and certification bodies themselves perform testing or calibration as the basis for making decisions on inspection or certification. 3.1 All types of bodies When assessing all conformity assessment bodies, SA uses the following documents: OA02: Acceptable traceability OA08: Accredited bodies reporting, OA07: Scope of accreditation, OA09: Guidance on legal status of parties in accreditation procedure and their changes. 3.2 Laboratories OA12: Equipment control OA05: Participation in interlaboratory comparisons ILAC G8: Guidelines on assessment and reporting of compliance with specification ILAC G24: Guidelines for the determination of calibration intervals of measuring instruments ILAC P10: ILAC Policy on traceability of measurement results EUROLAB Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025/2005 Specific guidance and interpretation documents relating to respective areas of accreditation are listed below. Revision 13 In use as of:28 March 2014 Page 2 of 5

3 Calibration laboratories OA07 Annex 4: Scope of accreditation in calibration ILAC P14: ILAC Policy for Uncertainty in Calibration. Testing laboratories OA06: Translation of EA-4/14 Selection and use of reference materials OA07d1: Scope of accreditation in testing OA10: EA Guidelines on the expression of uncertainty in quantitative testing translation of EA-4/16 Depending on the area of application in the accreditation procedures for testing laboratories the following guidance and interpretation documents can also be used: OA03: Uncertainty of measurement in chemical testing in accordance with the standard SIST EN ISO/IEC 17025, OA04: Measurements of wastewater flows, OA05d1: Special guidelines on participation in ILCs in chemical testing, EA-4/09: Accreditation for sensory testing laboratories, ILAC G19: Guidelines for forensic science laboratories, CITAC/EURACHEM Guide to quality in analytical chemistry, SIST TS CEN/TS15675: Air quality Measurement of stationary source emissions Application of EN ISO/IEC 17025:2005 to periodic measurements. 3.3 Inspection bodies OA07 - Annex 3: Scope of accreditation in inspection OA05 Participation in interlaboratory comparisons (when suitable) OA12: Control of equipment. 3.4 Certification bodies OA07d2: Scope of accreditation in certification bodies Certification bodies for products/processes/services IAF GD5 M: IAF Guidance on the application of ISO/IEC Guide 65:1996 Depending on the area of application in the accreditation procedures for certification bodies that certify products, the following guidance and interpretation documents can also be used: EA-6/02 M: Guidelines on the use of EN45011 and ISO/IEC17021 for certification to EN ISO3834 EA-6/04 M: EA Guidelines on the Accreditation of Certification of Primary Sector Products by Means of Sampling of Sites European Commission Guidelines on imports of organic products intro the European Union ( Revision 13 In use as of:28 March 2014 Page 3 of 5

4 Working document of the Commission services on official controls in the organic sector dated 8 July 2011 ( Regulation (EC) NO. 1235/2008 Codex Alimentarius CAC/GL 32 Guidelines for the production, Processing, Labelling and Marketing of Organically Produced Foods Certification bodies for management systems IAF MD 10: Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011 Depending on the area of application in the accreditation procedures for certification bodies that certify products, the following guidance and interpretation documents can also be used: EA-7/04 M: Legal Compliance as a part of accredited ISO 14001: 2004 certification Certification bodies for persons IAF GD 24 M: IAF Guidance on the application of ISO/IEC 17024: Environmental verifiers Commission Regulation (EC) No 1893/2006 of the European Parliament and of the Council establishing the statistical classification of economic activities NACE Revision 2 and amending Council Regulation (EEC) No 3037/90 as well as certain EC Regulations on specific statistical domains. 3.6 Assessment of verifiers of greenhouse gas emission reports relevant guidances available on web sites of EU, DG Clima Actions: EGD I Explanatory Guidance KGN II.2 Verifier s risk analysis KGN II.3 Process Analysis KGN II.4 Sampling KGN II.5 Site visits KGN II.6 Verification report KGN II.7 Competence KGN II.8 Relation between the AVR and EN ISO KGN II 10 Information Exchange KGN II.12 Time allocation GD III Verification Guidance for EU ETS Aviation Quick guide to verification of small emitters EA-6/03: EA Document for Recognition of Verifiers under EU ETS Directive. Revision 13 In use as of:28 March 2014 Page 4 of 5

5 3.7 Accreditation for notification purposes EA 2/17: EA Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes 4 CHANGES SINCE THE PREVIOUS REVISION OF THE DOCUMENT Guidances for certification and inspection bodies in sub-clause 3.4 and 3.5 have been amended, document EA-7/05 has been deleted due to invalidation. 5 TRANSITORY AND FINAL PROVISIONS The transitional period for the implementation of SIST EN ISO/IEC 17020:2012 expires on Until the end of transitional period a document Guidance on the application of ISO/IEC 17020:2004 (IAF/ILAC-A4:2004) is used. 6 CONTROL OF THE DOCUMENT The valid document is located in i4 (SA information system). A clean copy shall be published on SA's website, and shall be accessible in printed form at the SA Head Office. Any extracts from or copies of this document are only informative and not deemed to be controlled copies. The validity of these documents should be verified in i4. Revision 13 In use as of:28 March 2014 Page 5 of 5