EA/INF-01 List of EA Publications and International Documents Publication Reference EA-INF/01: 2014 List of EA Publications And International Documents PURPOSE This publication gives the list of EA documents to be used either on a mandatory or informative basis, according to the classification given in EA-1/14 Procedure for Development and Approval of EA Documents and the Adoption of ILAC/IAF Documents. It contains also the list of International documents approved by EA as applicable EA documents. May 2014 _rev 16 May 2014 1 of 14
Authorship This document has been prepared by the EA Secretariat. Official language The publication may be translated into other languages as required. The English language version remains the definitive version. Copyright Copyright of EA publications is held by EA, depending on the original publishing body. EA publications may be used as the basis of publications issued by member organisations, but acknowledgement in such publications to the source EA publication must be made. EA publications may not be copied for sale by any individual or body other than a member organisation Further information For further information about this publication, please contact the EA secretariat at: secretariat@european-accreditation.org Please check our website for up-to-date information at http://www.european-accreditation.org Category: Information and Promotional Documents Date of implementation: Immediate May 2014 _ rev 16 May 2014 2 of 14
CONTENTS 1 CLASSIFICATION OF DOCUMENTS... 4 2 DOCUMENT CONTROL... 5 3 EA PUBLICATIONS... 6 3.1 SECRETARIAT MANAGEMENT SYSTEM AND RELATED DOCUMENTS... 6 3.2 INFORMATION AND PROMOTIONAL DOCUMENTS... 6 3.3 EA GOVERNANCE AND POLICY DOCUMENTS... 6 3.4 PEER EVALUATION PROCESS DOCUMENTS... 8 3.5 MEMBERS PROCEDURAL DOCUMENTS... 8 3.6 APPLICATION DOCUMENTS AND TECHNICAL/ADVISORY DOCUMENTS FOR CONFORMITY ASSESMENTS BODIES (CABs)... 9 3.6.1 Laboratories - ISO/IEC 17025 / ISO 15189... 9 3.6.2 Inspection Bodies - ISO/IEC 17020... 10 3.6.3 Certification Bodies - EN 45011 - Products... 11 3.6.4 Certification Bodies - ISO/IEC 17021 - Management Systems... 11 4 INTERNATIONAL DOCUMENTS APPLICABLE TO EA, EA MEMBERS AND EA MLA SIGNATORIES... 11 4.1 GOVERNANCE AND POLICY DOCUMENTS... 11 4.2 PEER EVALUATION PROCESS DOCUMENTS... 11 4.3 MEMBERS PROCEDURAL DOCUMENTS... 12 4.4 APPLICATION DOCUMENTS FOR CONFORMITY ASSESSMENT BODIES... 13 4.4.1 Laboratories ISO/IEC 17025 / ISO 15189... 13 4.4.2 Inspection Bodies ISO/IEC 17020... 13 4.4.3 Certification Bodies EN 45011 - Products... 13 4.4.4 Certification Bodies ISO/IEC 17021 - Management Systems... 13 4.4.5 Certification Bodies ISO/IEC 17024 - Persons... 14 May 2014 _ rev 16 May 2014 3 of 14
1 CLASSIFICATION OF DOCUMENTS At its meeting in May 2009, the EA General Assembly decided to change the classification of the documents. EA Publication are now classified in 6 categories. Within one category, documents can have different status as shown below: Categories Status Numbering Secretariat Management System and related Documents Information and Promotional documents EA Governance and Policy documents Peer Evaluation Process documents, including policies and procedures Members Procedural documents Application documents and Technical/ for Conformity Assessment Bodies Not Applicable Not Applicable Not Applicable Not Applicable or or or or or /INFormative documents INFormative Technical / documents EA-0/XX EA-INF/XX A: documents relevant for EA as an Association :EA-1/XX A AB: documents relevant for Members: EA-1/XX AB EA-2/02 EA-2/XX M and EA-3/XX M or EA-2/XX G and EA-3/XX G EA-2/XX INF and EA-3/XX INF EA-4/XX M and EA-5/XX M EA-6/XX M and EA-7/XX M EA-4/XX G and EA-5/XX G EA-6/XX G and EA-7/XX G EA-4/XX INF and EA-5/XX INF EA-6/XX INF and EA-7/XX IN EA-4/XX TA and EA-5/XX TA EA-6/XX TA and EA-7/XX TA and other Organisations. EA Documents are required to be used by accreditation bodies when accrediting conformity assessment bodies to ensure that both operate their activities in a consistent and equivalent manner. EA Documents do not establish, interpret, subtract from or add to the requirements of any ISO/IEC/EN Guides and Standards or other technical specifications and normative documents, but assure consistent application of those documents. For further information on the categories of EA documents and its classification into,, Informative and Technical/ documents, see EA-1/14 Procedure for Development and Approval of EA Documents and the Adoption of ILAC/IAF Documents. May 2014 _ rev 16 May 2014 4 of 14
2 DOCUMENT CONTROL As owners of the EA publications, the EA Committees are responsible for the drafting, control and revision of their documents. The same applies for the documents owned by the EA Secretariat. The EA Secretariat is responsible for the preparation of the documents for publication on the EA web site according to EA-0/06 Format and Layout of EA Documents and EA-1/14 - Procedure for Development and Approval of EA Documents and the Adoption of ILAC/IAF Documents. Periodically, at least every 5 years, the Committees shall review the publications they are responsible for. For any question relating to a publication, please contact the Committee in charge or the EA Secretariat. In application of section 5 of EA-1/14, the list of International documents presented in this document is the list of ILAC, IAF and ILAC/IAF documents approved by the EA General Assemblies after review and upon recommendation of the EA Committee Chairs. May 2014 _ rev 16 May 2014 5 of 14
3 EA PUBLICATIONS 3.1 SECRETARIAT MANAGEMENT SYSTEM AND RELATED DOCUMENTS EA-0/00 EA-0/02 EA-0/06 (rev.02) EA-0/07 EA-0/08 EA-0/09 EA-0/10 EA-0/11 EA Management System Dec 2011 Procedure for Document Control Sept 2012 Format and Layout of EA Documents May 2009 EA Procedure for Application for EA Membership and Application Form July 2011 Procedure for management reviews Dec 2011 Procedure for internal audits Dec 2011 Procedure for EA Meetings Sept 2012 Specific Provisions for the Implementation of the Peer Evaluation of National Accreditation Bodies according to EN ISO 14065 and Commission Regulation (EU) No 600/2012 March 2014 3.2 INFORMATION AND PROMOTIONAL DOCUMENTS EA-INF/01 (rev.25) List of EA Publications (this publication) March 2014 EA-INF/02 (rev.12) Contact Persons of EA Members, Associate Members, Recognized Stakeholders and Observers Dec 2013 EA-INF/03 (rev.50) EA-INF/04 EA-INF/05 EA-INF/06 EA-INF/07 EA-INF/08 (rev00) EA Multilateral and Bilateral Agreements, and Signatory Lists Statement on acceptance and recognition of activities under the EA MLA previously EA-1/16 May 2014 Oct 2012 Press kit Sept 2007 A Guide to EA Sept 2011 Accreditation Body Communication with National Regulators - Best Practice Guide A Briefing For Government and Regulators 2013 June 2011 EA-INF/09 EA-INF/10 (rev00) EA-INF/11 (rev00) EA Guide on the Publication of Data on Accredited Verifiers Scope of the EA MLA and the application of an EA MLA signatory to join the IAF MLA for a specific main Scope of the EA MLA and the application of the EA MLA signatory to join the IAF MLA for a specific main scope/sub-scope and/or the ILAC MRA for Specific activity Jan 2014 Jan 2014 Apr 2014 May 2014 _ rev 16 May 2014 6 of 14
3.3 EA GOVERNANCE AND POLICY DOCUMENTS Documents are relating to the operation of EA as an association and a legal entity. The following letters are added to the document number: A: documents relevant for EA as an Association e.g. EA-1/XX A AB: documents relevant for EA Members e.g. EA-1/XX AB Articles of Association July 2011 EA-1/06 A+AB (rev.07) EA-1/13 A EA-1/14 A EA Multilateral Agreement Criteria for signing Policy and procedure for development EA s Relationship with Accreditation Bodies of Countries Not Being Members of the EU or EFTA Procedure for Development and Approval of EA Documents and the Adoption of ILAC/IAF Documents Sept 2013 May 2009 Feb 2011 EA-1/15 A EA-1/17 A (rev.05) EA-1/17 S1 A+AB (rev.02) EA Policy for Relations with Stakeholders Jan 2010 EA Rules of Procedure Nov 2013 Criteria for May 2011 Membership EA-1/17-S3 A (rev.03) EA-1/17 S4 A EA-1/17 S5 A+AB EA-1/18 A EA Supplement 3 to EA-1/17, EA Rules of Procedure - Complaint and Appeal Procedures EA Supplement 4 to EA-1/17 S4, EA Rules of Procedure - Proxy Procedure EA Supplement 5 to EA-1/17, EA Rules of Procedure - Levying of Membership Fees Procedure and Policy for Expansion of the Scope of the EA MLA Document withdrawn cf EA Resolution 2013 (32)09 of the EA General Assembly in May 2013. Replaced by the adoption of revised EA-1/06 A AB:2013: EA Multilateral Agreement: Criteria for Signing Policy and Procedures for Development June 2011 Feb 2001 June 2002 July 2011 EA-1/19 A+AB Rules for Use of EA logo (previously EA-0/01) Oct 2008 EA-1/20 A (rev.02) EA-1/20 S1 A+AB (rev.02) EA-1/21 A+AB EA-1/22 A+AB EA Procedure for the Control of Expenditures and Preparation of Budgets (previously EA-0/05) EA Supplement 1 to EA-1/20, EA Procedure for the Control of Expenditures and Preparation of Budgets Terms and Conditions for financial compensation from the operating/action grant to an EA Member Accreditation Body EA Internal Procedure for Liaison Activities (previously EA- 0/04) EA Policy for Conformity Assessment Schemes (Sector Schemes) former EA-2/11 Sept 2012 Nov 2013 July 2008 Jan 2006 May 2014 _ rev 16 May 2014 7 of 14
3.4 PEER EVALUATION PROCESS DOCUMENTS Policy and procedural documents for the operation and management of the EA peer evaluation system, training of evaluators and liaison with the Arrangement Committees of ILAC and IAF. EA-2/02 (rev.06) EA Policy and Procedures for the Multilateral Agreement June 2011 3.5 MEMBERS PROCEDURAL DOCUMENTS Procedures, requirements etc. applying to EA members including application documents for accreditation bodies. Documents in this section can be either mandatory (M) or guidance (G) or informative (INF) documents EA-2/09 INF Informative EA Policy on the Accreditation of Providers of Proficiency Testing Schemes Sept 2000 Transitory EA-2/13 M EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members Dec 2007 EA-2/13 M EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members Oct 2012 EA-2/13 S1 M EA Supplement 1 to EA-2/13, Interpretation of Terminology used in clause 5.1 of EA- 2/13 Aug 2013 EA-2/14 M Procedure for Regional Calibration ILCs in Support of the EA MLA June 2008 EA-2/15 M EA Requirements for the Accreditation of Flexible Scopes July 2008 EA-2/17 M EA on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes July 2009 EA-3/01 M (rev.03) EA conditions for the use of accreditation symbols, text reference to accreditation and MLA signatory status Dec 2012 EA-3/04 G Use of Proficiency Testing as a Tool for Accreditation in Testing (with EUROLAB and EURACHEM). Reinstated according to EA Resolution 2012(29)24 Aug 2001 EA-3/05 G Guidelines for Training Courses for assessors used by Laboratory Accreditation Schemes (previously EAL-G7) Document withdrawn cf EA Resolution 2013(31)26 of the EA General Assembly in May 2013 and replaced by ILAC G3:08/2012 Guidelines for Training Courses for Assessors Used by Accreditation Bodies Sept 1993 EA-3/06 G Guidelines for Selection of Participants to Courses for the Training of assessors Involved in Assessments of Laboratories Applying for Accreditation (previously EAL- G8) Nov 1994 May 2014 _ rev 16 May 2014 8 of 14
Document withdrawn cf EA Resolution 2013(31)26 of the EA General Assembly in May 2013 and replaced by ILAC G3:08/2012 Guidelines for Training Courses for Assessors Used by Accreditation Bodies EA-3/07 G Programme for Course for Tutors for Assessor Training (previously EAL-G10) Sept 1993 Document withdrawn cf EA Resolution 2013(31)26 of the EA General Assembly in May 2013 and replaced by ILAC G3:08/2012 Guidelines for Training Courses for Assessors Used by Accreditation Bodies EA-3/09 INF Informative Surveillance and Reassessment of accredited organisations Document withdrawn cf EA Resolution 2013(31)21 of the EA General Assembly in May 2013 June 2010 EA-3/11 M Food Safety Management Systems Scope of Accreditation May 2009 EA-3/12 M EA Policy for Accreditation of Organic Production Certification June 2013 3.6 APPLICATION DOCUMENTS AND TECHNICAL/ADVISORY DOCUMENTS FOR CONFORMITY ASSESSMENTS BODIES (CABs) Documents used by Conformity Assessment Bodies providing technical or scientific guidance for the application of standards. The documents of this category can be either: (M) or (G) or Informative (INF) or Technical/ (TA) 3.6.1 Laboratories - ISO/IEC 17025 / ISO 15189 EA-4/02 M Expressions of the Uncertainty of Measurements in Calibration (including supplement 1 to EA-4/02) (previously EAL- R2) Sept 2013 EA-4/07 M Traceability of Measuring and Test Equipment to National Standards (previously EAL-G12) Nov 1995 Document withdrawn cf EA Resolution 2013(31)27 of the EA General Assembly in May 2013 and replaced by ILAC P10:01/2013: ILAC Policy on Traceability of Measurement Results EA-4/09 G Accreditation for Sensory Testing Laboratories (previously EAL-G16) July 2003 EA-4/10 G (rev.02) Accreditation for Laboratories Performing Microbiological Testing (previously EAL- G18) July 2002 EA-4/14 INF Informative Selection and Use of Reference Materials Feb 2003 May 2014 _ rev 16 May 2014 9 of 14
EA-4/15 G Accreditation for Bodies Performing non- Destructive Testing Feb 2003 EA-4/16 G EA Guidelines on the Expression of Uncertainty in Quantitative testing Dec 2003 EA-4/17 M EA Position Paper on the description of scopes of accreditation of medical laboratories Dec 2008 EA-4/18 INF Informative on the level and frequency of proficiency testing participation March 2010 CEC TA Technical / ISO/IEC 17025 interpretation document for CEC test methods Coordination European Council: Ian Brown Aug 2006 CITAC/ EURACHEM TA Technical Guide to Quality in analytical Chemistry July 2005 Validation of analytical procedures May 2005 Scope of accreditation of official medicines laboratories May 2005 Uncertainty of measurement May 2005 Standard Aide Mémoire for the Mutual Joint Audit of OMCLs Dec 2007 Qualification of Equipment (core document) Dec 2007 Annex 1: Qualification of HPLC equipment Dec 2007 Annex 2: Qualification of GC equipment Dec 2007 EWDTS TA Technical / Annex 3: Qualification of UV visible spectrophotometers Annex 4: Qualification of IR spectrophotometers Aide Mémoire for environmental conditions and treatment of biological models European Laboratory Guidelines for Legally Defensible Workplace Drug Testing Contact Person: R. Jonsson Dec 2007 Dec 2007 Dec 2007 May 2005 EWDTS TA Technical/ Drug and Alcohol Testing in Hair, Collection and Analysis Aug 2010 EWDTS TA Technical/ Guidelines for oral fluid March 2011 3.6.2 Inspection Bodies - ISO/IEC 17020 EA-5/02 TA Technical / on the Application of EN 45004 in recurrent inspection of motor vehicles. June 2007 EA-5/03 M for the implementation of ISO/IEC 17020 in the field of crime scene investigation Dec 2008 May 2014 _ rev 16 May 2014 10 of 14
3.6.3 Certification Bodies - EN 45011-ISO/IEC 17065 - Products EA-6/02 M (rev.02) EA Guidelines on the Use of EN 45011 and ISO/IEC 17021 for Certification to EN ISO 3834 July 2013 EA-6/03 M (rev.04) EA Document For Recognition of Verifiers under EU ETS Directive Nov 2013 EA-6/04 M EA Guidelines on the Accreditation of Certification of Primary Sector Products by Means of Sampling of Sites July 2011 3.6.4 Certification Bodies - ISO/IEC 17021 - Management Systems EA-7/04 M (rev.02) Legal Compliance as a part of accredited ISO 14001: 2004 certification April 2010 EA-7/05 M EA on the Application of ISO/IEC 17021: 2006 for Combined Audits Document withdrawn cf EA Resolution 2013(31)32 of the EA General Assembly in May 2013 and replaced by IAF MD11:2013: IAF Document for the Application of ISO/IEC 17021 for Audits of Integrated Management Systems Oct 2008 4 INTERNATIONAL DOCUMENTS APPLICABLE TO EA, EA MEMBERS AND EA MLA SIGNATORIES The documents listed in this section shall be implemented within two years from April 2012. 4.1 GOVERNANCE AND POLICY DOCUMENTS ILAC-P4 1 ILAC Mutual Recognition Arrangement (Arrangement): Policy Statement Oct 2013 ILAC-P5 1 ILAC Mutual Recognition Arrangement (Arrangement) Oct 2013 ILAC-P12 2 Harmonisation of ILAC Work with the Regions April 2009 4.2 PEER EVALUATION PROCESS DOCUMENTS IAF/ILAC A1 2 IAF/ILAC MRAs: Evaluation of a Regional Group Feb 2014 IAF/ILAC A2 2 IAF/ILAC MRAs: Evaluation of a Single Accreditation Body Feb 2014 IAF/ILAC A3 3 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Narrative Framework for Reporting on the Performance of an Accreditation Body - A Tool for the Evaluation Process Jan 2013 1 Applicable for EA members signatory to the ILAC Arrangement 2 Applicable to EA as a Region 3 Applicable to all May 2014 _ rev 16 May 2014 11 of 14
4.3 INFORMATION AND PROMOTIONAL DOCUMENTS IAF ID 5 3 Informative Document for the Transition of Information Security Management System Accreditation to ISO/IEC 27006:2011 from ISO/IEC 27006:2007 Withdrawn 4.4 MEMBERS PROCEDURAL DOCUMENTS IAF/ILAC A5 4 ILAC-P9 5 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004 ILAC Policy for Participation in National and International Proficiency Testing Activities Nov 2013 Nov 2010 ILAC-P10 5 ILAC Policy on Traceability of Measurement Results Jan 2013 ILAC-P13 5 ILAC-G3 4 ILAC-G18 5 ILAC-G21 5 ILAC-G22 4 IAF ML 5 6 Application of ISO/IEC 17011 for the Accreditation of Proficiency Testing Providers Guidelines for Training Courses for Assessors Used by Accreditation Bodies Guidelines for the Formulation of Scopes of Accreditation for Laboratories Cross Frontier Accreditation - Principles for Avoiding Duplication Use of Proficiency Testing as a Tool for Accreditation in Testing Document withdrawn cf EA Resolution 2012 (30) of the EA General Assembly in November 2012 based on ILAC resolution GA 16.22.decision Procedure for IAF Listing of Foreign Critical Locations (FCLs/Foreign Premises (FPs) Oct 2010 Aug 2012 April 2010 Sept 2012 Withdrawn 2008 IAF GD 3 6 on Cross Frontier Accreditation 2003 IAF MD 6 4 Application of ISO 14065:2007 2014 IAF MD 7 6 Harmonization of Sanctions 2010 IAF MD 8 4 Application of ISO/IEC 17011 in Medical Devices QMS (ISO 13485) 2011 IAF PL 1 6 Code of Conduct for Members of the IAF 2009 IAF PL 6 6 Memorandum of Understanding 2009 4 Applicable to all 5 Applicable to EA members signatories to ILAC Arrangement 6 Applicable to EA members signatories to the IAF MLA May 2014 _ rev 16 May 2014 12 of 14
ILAC-P8 5 ILAC Mutual Recognition Arrangement (Arrangement): Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Laboratories Dec 2012 ILAC-R7 5 Rules for the Use of the ILAC MRA Mark Sept 2009 IAF ML 1 6 Procedure for Exchange of Documentation among IAF MLA Accreditation Bodies 2011 IAF ML 2 6 General Principles for Use of the IAF MLA Mark 2011 IAF ML 3 6 Procedure on Responding to Inquiries on Multilateral Recognition Arrangement (MLA) Signatory Equivalence 2012 4.5 APPLICATION DOCUMENTS FOR CONFORMITY ASSESSMENT BODIES 4.5.1 Laboratories ISO/IEC 17025 / ISO 15189 ILAC-P10 7 ILAC Policy on Traceability of Measurement Results Jan 2013 ILAC-P14 7 ILAC Policy for Uncertainty in Calibration Jan 2013 4.5.2 Inspection Bodies ISO/IEC 17020 IAF/ILAC A4 7 on the Application of ISO/IEC 17020 2004 4.5.3 Certification Bodies EN 45011 - Products IAF GD 5 7 on ISO/IEC Guide 65:1996 2006 4.5.4 Certification Bodies ISO/IEC 17021 - Management Systems IAF MD 1 7 Certification of Multiple Sites Based on Sampling 2007 IAF MD 2 7 IAF MD 3 7 IAF MD 4 7 Transfer of Accredited Certification of Management Systems Advanced Surveillance and Recertification Procedures (ASRP) Use of Computer Assisted Auditing Techniques ("CAAT") for Accredited Certification of Management Systems 2007 2008 2008 IAF MD 5 7 Duration of QMS and EMS Audits 2013 IAF MD 9 7 Application of ISO/IEC 17021 in Medical Devices QMS (ISO 13485) 2011 IAF MD 10 7 Assessment of Certification Body Management of Competence in accordance with ISO/IEC 17021: 2011 2013 7 Applicable to all May 2014 _ rev 16 May 2014 13 of 14
IAF MD11 7 IAF MD12 7 IAF Document for the Application of ISO/IEC 17021 for Audits of Integrated Management Systems Assessment of Certification Activities for Cross-Frontier Accreditation 2013 2013 4.5.5 Certification Bodies ISO/IEC 17024 - Persons IAF GD 24 7 on the Application of ISO/IEC 17024:2003 2009 May 2014 _ rev 16 May 2014 14 of 14