IAAC, IAF and ILAC Resolutions Applicable to IAAC MLA Peer Evaluations CLASSIFICATION This document is classified as an IAAC Mandatory Document. AUTHORIZATION Issue Nº: 07 Prepared by: MLA Committee and Technical Committee Date: March 2017 Revision Nº: 00 Approved by: MLA Committee Issue Date: March 7, 2017 Application Date: Immediate Document number: IAAC MD 030/17 Inquiries: IAAC Secretariat Telephone: +52 (55) 9148-4300 e-mail: secretariat@iaac.org.mx AVAILABILITY Copies of this document in English and Spanish are available at the IAAC Secretariat and on the IAAC web site. COPYRIGHT IAAC holds the copyright of this document and it may not be copied for resale. Original: English Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 1 of 12
IAAC, IAF & ILAC Resolutions Applicable to IAAC MLA peer evaluations 1 PURPOSE This document lists all resolutions approved by IAAC, ILAC and/or IAF General Assemblies and IAAC MLAG/MLAC which establish requirements applicable to IAAC peer evaluations. It only includes resolutions that have yet not been included in other ILAC, IAF and/or IAAC documents mandatory for the IAAC MLA. 2 IAF/ILAC RESOLUTIONS APPLICABLE TO IAAC PEER EVALUATIONS RESOLUTION NUMBER TEXT MLAG/2017/23 Transition period for ISO 17034 The MLA Group agrees that: 1) Each MLA Group member shall submit a report to the MLAG on the implementation of ISO 17034: 2016, before each MLAG meeting held before the deadline of November 2019. 2) Each MLAG member shall submit a final report to the MLAG on November 2019. 3) In case an MLA signatory has not implemented ISO 17034: 2016 by the deadline, the MLA Group shall suspend the signatory status from the MLA management system certification scopes, until evidence that it has implemented ISO 17034:2016, is submitted to the MLA Group. ILAC Resolution GA 20.15 As the revised version of ISO/IEC 17025 is scheduled for publication in 2017, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. At the end of the transition period, accreditation of a laboratory to ISO/IEC 17025:2005 will not be recognised under the ILAC Arrangement. ILAC Resolution GA 20.14 As a result of the publication of ISO 17034 in November 2016, replacing ISO Guide 34:2009, the General Assembly endorses the recommendation from the AIC, that accreditation of reference material producers be conducted in accordance with ISO 17034 and that an implementation period of 3 years be adopted. JGA Delhi Resolution 1 Transition to ISO/IEC 17011:2017 The Joint General Assembly endorses the Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 2 of 12
IAF Resolution 2016-17 IAF Resolution 2016-14 recommendation of the Joint Executive Committee, that the transition period for the revised ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies due for publication in August 2017 will be three years from the date of publication of the revised standard. Accredited MS Certification Document - Further to Resolution 2015-14, The General Assembly, acting on the recommendation of the Technical Committee, resolved that in order for a management system certification document to be considered accredited, it must display the accreditation symbol, and/or, reference the accreditation status of the CB including the identification of the AB. The General Assembly further agreed that management systems certification bodies: 1. must transition certification documentation to include the accreditation symbol, and/or, reference the accreditation status of the CB including the identification of the AB, at the time of recertification decision; no later than 06 November 2019; 2. when granted initial accreditation (for a standard or scope), as of 06 November 2016, the CB must transition (reissue) previous unaccredited certification documents, within one year after the accreditation decision; 3. must apply this resolution to all management system standards. Note: If there is an exception to the above, the client must justify the exception to the CB and AB, and if accepted by both the CB and AB, the certification is still considered accredited. Transitional Arrangement for the Revision of ISO/IEC TS 17021-2: - The General Assembly, acting on the recommendation of the Technical Committee, resolved that the transition period for the next revision of ISO/IEC TS 17021-2: Conformity assessment -- Requirements for bodies providing audit and certification of Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 3 of 12
IAF Resolution 2016-13 IAAC GA/2016/06 management systems -- Part 2: Competence requirements for auditing and certification of environmental management systems, will be two years from the date of publication of the revised standard. Accreditation Scoping for Energy Management Systems (EnMS) - The General Assembly, acting on the recommendation of the Technical Committee, resolved to endorse Table 2 Technical Areas from ISO 50003:2014 Energy management systems -- Requirements for bodies providing audit and certification of energy management systems as a Normative reference for the accreditation scope and grouping of sectors for witnessing of energy management systems. Criteria for the expression of the accreditation scopes for product certification bodies The General Assembly agrees to the following criteria for compliance with clause 7.9.5 a) of ISO/IEC 17011:2004 (equivalent to clause 7.8.3 of DIS 17011). The minimum and necessary information that the scope of accreditation of product certification bodies shall include is: -Conformity assessment scheme, -Standards, normative documents or regulatory requirements applicable to the product, process or service. -Product, process or service certified The General Assembly requests the MLAC Committee to include these criteria in the MD 030 and in FM 003. The implementation deadline is March 9, 2017. The Promotions Subcommittee will undertake the corresponding promotion. The General Assembly agrees that this information will be presented at the IAF TC meeting in New Delhi, India on November 2016 Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 4 of 12
as an outcome of this meeting. IAF Resolution 2015 12 Transitional Arrangement for ISO/IEC 27006:2015 - The General Assembly, acting on the resolved that the transition period for ISO/IEC 27006:2015 Information technology -- Security techniques -- Requirements for bodies providing audit and certification of information security management systems will be two years from the date of publication of the standard, i.e. 30 September 2017 IAF Resolution 2015 13 Transitional Arrangement for the Revision of ISO 13485:2003 - The General Assembly, acting on the resolved that the transition period for the next revision of ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes will be three years from the date of publication of the revised standard. IAF Resolution 2015 14 Non-Accredited Certification Where the MS CB is Accredited for the Same Scope - The General Assembly, acting on the recommendation of the Technical Committee, resolved that IAF Accreditation Body members shall have legally enforceable arrangements with their accredited CABs that prevents the CAB from issuing nonaccredited management systems certificates in scopes for which they are accredited. The General Assembly further agreed that the transition period will be one year from the date of endorsement. ILAC Resolution 18.18 The General Assembly agrees to the withdrawal of ILAC G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers. In so doing, the General Assembly rescinds the previous General Assembly resolution (ILAC Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 5 of 12
Resolution GA 14.17 agreed in Shanghai in 2010) to withdraw ILAC G12:2000 following the publication of a document proposed at that time as ILAC XX Guidance for the Assessment of Reference Material Producers. ILAC Resolution 18.19 IAF Resolution 2014 11 The General Assembly agrees to the withdrawal of ILAC-G9:2005 Guidelines for the Selection and Use of Reference Materials following the publication of ISO Guide 33 Reference materials- Good practice in using reference materials. ISO 14001: 2015: Environmental Management Systems Requirements with guidance for use - resolved to endorse ISO 14001: 2015 as a normative document. The General Assembly further agreed that the transition period of ISO 14001: 2015 will be three years from the date of publication. IAF Resolution 2014-12 (Agenda Item 8) - ISO/IEC 17021-1:2015: Conformity Assessment Requirements for Bodies Providing Audit and Certification of Management Systems - resolved to endorse ISO/IEC 17021-1:2015, as a normative document. The General Assembly further agreed that the transition period for the implementation of ISO/IEC 17021-1:2015 will be two years from the date of publication. IAF Resolution 2014-1 ISO 50001: Energy management systems -- Requirements with guidance for use and ISO 50003: Energy management systems -- Requirements for bodies providing audit and certification of energy management systems - recognizes that the ISO 50001 and ISO 50003 are the appropriate standards for certification and accreditation in the energy management systems field. The General Assembly further agreed that the implementation period for ISO 50003:2014 will be three years from the date of publication. Note: As the date of publication was 14 October Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 6 of 12
2014, the deadline for Certification Bodies to conform will be 14 October 2017. IAF Resolution 2014-17 IAF Resolution 2013 12 Seoul, October 2013 Endorsement of ISO/IEC TS 17021-3:2013 - IAF Resolution 2013 13 Seoul, October 2013 Endorsement of ISO/IEC 27001:2013 - IAF MLA for Accreditation of Greenhouse Gas (GHG) Validation and Verification Bodies - The General Assembly, acting on the recommendation of the Executive Committee, resolved to extend the scope of the IAF MLA to include the accreditation of GHG Validation and Verification Bodies, noting that the extension of the MLA will be part of the IAF MLA based on the Main scope, ISO 14065. The scope extension process can commence on acceptance of this Resolution resolved to endorse ISO/IEC TS 17021-3:2013 Conformity Assessment Requirements for bodies providing audit and certification of management systems Part 3: Competence requirements for auditing and certification of quality management systems, as a normative document to be applied in conjunction with ISO/IEC 17021 for QMS. The General Assembly further agreed that the deadline for conformance to ISO/IEC 17021-3 will be two years from the date of publication. Note: As the publication date was 2 May 2013, the deadline for Certification Bodies to conform will be 2 May 2015. resolved to endorse ISO/IEC 27001:2013 Information technology - Security techniques - Information security management systems Requirements, as a normative document. The General Assembly further agreed that the deadline for conformance to ISO/IEC 27001:2013 will be two years from the date of publication. One year after publication of ISO/IEC 27001:2013, all new accredited Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 7 of 12
certifications issued shall be to ISO/IEC 27001:2013. IAF Resolution 2013 14 Seoul, October 2013 Endorsement of Revision of ISO/TS 22003:2007 - IAF Resolution 2013 15 Seoul, October 2013 Endorsement of Revision of ISO 9001:2008 IAF Resolution 08 IAF Resolution 09 Note: As the date of publication was 1 October 2013, the deadline for Certification Bodies to conform will be 1 October 2015. The General Assembly acting on the resolved to endorse the next revision of ISO/TS 22003:2007 Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems, as a normative document. The General Assembly further agreed that the transition period for the next revision of ISO/TS 22003:2007 will be three years from the date of publication. The General Assembly acting on the resolved to endorse the next revision of ISO 9001:2008 Quality management systems Requirements, as a normative document. The General Assembly further agreed that the transition period for the next revision of ISO 9001:2008 will be three years from the date of publication. Note: It was suggested that Conformity Assessment Bodies should encourage their clients to commence working on the transition as early as possible. Transition Period for ISO/IEC 27006 - resolved that the period for the transition of Information Security Management System Accreditation to ISO/IEC 27006: 2011 from ISO/IEC 27006: 2007 be 18 months from the date of publication. Note: The date of publication was 1 December 2011. Transition Period for ISO/IEC 17065 - resolved that the transition period for Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 8 of 12
IAF Resolution 10 IAF Resolution 11 IAF Resolution 12 ILAC Resolution GA 16.20 ILAC Resolution GA 16.21 ISO/IEC17065: be three years from the date of publication. Note: The date of publication was 15 September. Transition Period for ISO/IEC 17024 - The General Assembly resolved that the transition period for ISO/IEC17024: be three years from the date of publication. Notes: The date of publication was 1 July. (Resolution -10 was approved on 24 October with 4 abstentions and 5 negative votes) General Transition Period for ISO/CASCO Publications - resolved that the transition for the implementation of all relevant newly published ISO/CASCO conformity assessment standards shall be two years from the date of publication, unless overridden by the need to produce a specific application document as agreed by the IAF Technical Committee. Endorsing a normative document resolved to endorse ISO/IEC TS 17021-2 as a normative document to be applied in conjunction with ISO/IEC 17021 for EMS. The deadline for conformance to ISO/IEC TS 17021-2 shall be the default two years from the date of publication. Note: As the publication date was 15 August, the deadline for Certification Bodies to conform is 15 August 2014. As ISO Guide 34:2009 includes normative references to ISO/IEC 17025 and ISO 15189, the General Assembly resolves that accreditation of reference material producers is conducted in accordance with ISO Guide 34:2009 alone. This resolution rescinds ILAC resolution 8.12. In addition ILAC R6:07/ will be amended to reflect this decision. Noting the results of the ISO ballot completed for ISO FDIS 15189 on 11 October, the Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 9 of 12
General Assembly agrees that by 1 March 2016, all references to ISO 15189 in accreditation certificates (as defined and described in ISO/IEC 17011), shall refer to the latest edition of ISO 15189. Compliance will be determined during normal surveillance or reassessment activities or as a separate activity. At the end of the transition period, accreditation of a laboratory to ISO 15189:2007 will not be recognised under the ILAC Arrangement. ILAC Resolution GA 16.23 ILAC Resolution GA 16.26 IAF Resolution 2010 12 Shanghai, October 2010 Transition Period for ISO/IEC 17021 As agreed by the ILAC membership in the ballot Rationale for the proposed Period for Transition to ISO/IEC 17020: conducted in July, the transition period for the implementation of ISO/IEC 17020: Conformity assessment Requirements for the operation of various types of inspection bodies performing inspection will expire on 1 March 2015. At this time, all accreditation certificates issued (as described and defined in ISO/IEC 17011) must reference the edition of ISO/IEC 17020. Compliance will be determined during normal surveillance or reassessment activities or as a separate activity. After 1 March 2015, inspection bodies accredited to the previous version of ISO/IEC 17020 will not be recognised under the ILAC Arrangement. The General Assembly agrees that the Proficiency Testing Consultative Group will be disbanded and reconstituted as a Proficiency Testing Working Group under the Accreditation Committee (AIC). Commencing in 2013, meetings of the working group will occur annually in conjunction with the AIC mid-year meetings, and participation will be open to all interested ILAC members and stakeholders as well as PT providers. resolved that the transition period for the implementation of the revision of ISO/IEC 17021 Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 10 of 12
ILAC Resolution GA 13.25 Vancouver, October 2009 IAF/ILAC JGA 2007 Sydney Resolution 6 - International Accreditation Day: IAF Resolution 2006-15 Assessment of Foreign Critical Locations for Product Certification IAF Resolution 2006-14 Assessment of Foreign Critical Locations for QMS and EMS IAF Resolution 2005-14 Accreditation of Training Course Providers will be 24 months from the date of publication. Confirming that ISO 15189 is covered by the ILAC Arrangement for testing, the General Assembly resolves that when accrediting Point of Care Testing (POCT) units, the following applies with a transition period of two years from 20 October 2009: 1. All parts of ISO 15189 shall be covered (with the exception of exempted clauses as indicated in ISO 22870) when accrediting POCT using ISO 22870. 2. The certificate of accreditation shall refer to both ISO 15189 and ISO 22870. The IAF and ILAC Joint General Assembly endorses the proposal presented by the JWG Communications to establish June 9th as the annual International Accreditation Day. recommendation of the MLA Committee, resolved that all Foreign Critical Locations (FCLs) included in accreditation scopes for product certification on or before 31 December 2006 shall be initially assessed on-site at least once by an IAF MLA member AB for scopes of accreditation for product certification being covered by the FCLs, no later than 31 December 2008. recommendation of the MLA Committee, resolved that all Foreign Critical Locations (FCLs) included in accreditation scopes for ISO 9001 QMS and ISO 14001 EMS on or before 31 December 2006 shall be initially assessed onsite at least once by an IAF MLA member AB for all scopes of accreditation for ISO 9001 QMS and ISO 14001 EMS being covered by the FCLs, no later than 31 December 2007. Given that a training course provider is not a conformity assessment body and so by definition assessment and approval of a training course provider is not accreditation; and given that as ISO/IEC 17011:2004, clause 4.3.6.a, states that an accreditation body will not provide any service that affects its impartiality such as those conformity assessment services that Conformity Assessment Bodies (CABs) perform, such as the certification of service providers based on Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 11 of 12
IAF Resolution 2003-18 Conformity Assessment Services ISO/IEC Guide 65, the General Assembly, acting on the recommendation of the Technical Committee, resolved that accreditation of training course providers is not in conformance with ISO/IEC 17011:2004. The Annual Meeting, acting on the in support of the principle that IAF, its members and their constituents, should avoid actions that create confusion or conflict of interest between the respective roles of accreditation bodies and certification/registration bodies, resolved that IAF will not endorse 1. the provision of any conformity assessment services by Accreditation Body members of IAF (other than insofar as the accreditation of Conformity Assessment Bodies may be termed a conformity assessment service) 2. the provision of any conformity assessment services by accredited Conformity Assessment Bodies to denote conformity with any of the standards that are used as the basis for accreditation. Note: Currently, services identified as conformity assessment services are: - Calibration (ISO/IEC 17025) - Testing (ISO/IEC 17025 and ISO 15189) - Inspection (ISO/IEC 17020) - Management System Certification (future ISO/IEC 17021) - Personnel Certification (ISO/IEC 17024) - Product Certification (ISO/IEC Guide 65) Date of Issue: March 7, 2017 IAAC MD 030/17 Pages 12 of 12