Inter American Accreditation Cooperation. IAAC Transition from ISO/IEC 17011:2004 to ISO/IEC 17011:2017

Transcription

1 IAAC Transition from ISO/IEC 17011:2004 to ISO/IEC 17011:2017 CLASSIFICATION This document is classified as an IAAC Mandatory Document. AUTHORIZATION Issue Nº: 01 Prepared by: MLA Committee Date: March 2016 Revision Nº: 00 Approved by: General Assembly Issue Date: August 31, 2018 Application Date: Immediate Document number: IAAC MD 48/18 Inquiries: IAAC Secretary Telephone: +52 (55) AVAILABILITY Copies of this document in English are available at the IAAC Secretariat and on the IAAC website. COPYRIGHT IAAC holds the copyright of this document and it may not be copied for resale. Original: English Date of Issue: August 31, 2018 IAAC MD 048/18 Page 1 of 5

2 1. BACKGROUND: Inter American Accreditation Cooperation The ILAC and IAF members agreed on a three years transition period, as stated in JGA Delhi Resolution 1 - Transition to ISO/IEC 17011:2017 The Joint General Assembly endorses the 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. IAAC has to implement a transition process that takes into account the recommendation of the Joint General Assembly of IAF and ILAC which states: JGA Vancouver Resolution Transition process to ISO/IEC 17011:2017 The Joint General Assembly endorses the recommendation of the Joint Executive Committee, to ensure JGA Delhi Resolution 1 Transition to ISO/IEC 17011:2017 is fully implemented, that all peer evaluation activities carried out from 1 January 2018 will use ISO/IEC 17011:2017 as the requirements document. Details for this transition plan and the reporting requirements to the ILAC AMC and IAF MLA MC were provided in the JGA agenda papers. The official publication date of ISO/IEC is November 2017, which means IAAC will have to ensure that all MLA Signatories have completed the transition successfully before November GENERAL CONDITIONS: 2.1. Any AB not yet signatory of the MLA, applying after January 2018, shall apply according ISO/IEC 17011: All IAAC MLA signatories, shall demonstrate conformance with ISO/IEC 17011:2017, by the end of the transition period The MLA Signatory not complying with ISO/IEC 17011:2017 after the transition date, will be suspended from the MLA. 3. PROCESS TO DEMONSTRATE COMPLIANCE WITH THE LATEST VERSION: 3.1. Every signatory will have to develop a transition plan, that may considered: Training and awareness for all key personal for the assessment and accreditation process Updating of the AB quality system and any additional action to be develop by the AB to comply with the following requirements of ISO/IEC 17011:2017: 4.2 e), g), k) e), 4.3.2, a), b), c), d), e), f) 4.4.3, 4.4.6, 4.4.7, 4.4.8, 4.4.9, a), d) Date of Issue: August 31, 2018 IAAC MD 048/18 Page 2 of 5

3 4.6.3, a), f), e), f), h), j) Clause , , , 7.4.5, 7.4.6, , 7.6.3, a) (detail in writing any nonconformities), c) , if applicable 7.9.1, 7.9.2, 7.9.3, 7.9.4, , , , 8.1.2, 8.1.3, d), i) 3.2. The compliance with the new version of the standard will be determine as follow: From July 2018 all peer evaluation will be carried out with the new version of the standards The ABs that are not peer evaluated during the period from July 2018 to December 2019, will have to fill out a revised version of IAAC FM 003 and provide documentary evidence (procedures and records) of compliance with the new or modified requirements (those identified in 3.1.2), and the deadline to present the checklist and evidence of implementation is December A lead evaluator or experienced evaluator, assign by the MLAC Chair, will review that checklist and relevant documentation and issue a report (see annex 1), including findings (NC, concerns, comments), by March Note: For large ABs it may be useful to appoint more than one evaluator to review the documentation. Virtual or remote process may be acceptable for option For any of the above evaluation process, any noncompliance with the new or modified requirements will be identified as a non-conformity against ISO/IEC 17011:2017, and will have to be addressed by the AB no later than June All decisions related with the transition will be done by the MLAG, and no later than August Date of Issue: August 31, 2018 IAAC MD 048/18 Page 3 of 5

4 ANNEX 1: CONTENT OF THE EVALUATION OF THE TRANSITION PROCESS A. Summary: This is a report on the evaluation of the <<insert full name and (acronym) of AB>> on behalf of the Inter-American Accreditation Cooperation (IAAC) for the purpose to confirm the transition to the new ISO/IEC 17011:2017 by <<insert full name and (acronym) of AB>>. The evaluation took place from <<insert day and date>> to <<insert day and date>> The evaluation team was impressed with <<list those elements that are especially noteworthy>> <<TL: insert brief summary of the findings in relation to nonconformities>> <<as relevant>> The evaluation team raised <<number>> nonconformities, relate to <<brief statement on the new or modified requirement of ISO/IEC 17011:2017. Full details of all nonconformities, are given in Annex X <<TL: insert IAF-ILAC A3, Annex I, with nonconformities>>to this report. <<as relevant>> <<insert acronym of AB>> is required to respond to those findings within the deadline established in IAAC Transition process. The evaluation team will forward its recommendation to the IAAC MLA Group when it has received satisfactory responses to nonconformities. <<Names and affiliation of the members of the evaluation team>> << Evaluator s name (Team Member; AB2, Country)>> <<Evaluator s name (Team Member; NMI, Country)>> B. Description of the outcomes of the evaluation: Related with the new or modified requirements of ISO/IEC applicable to the MLA subscopes. <<As relevant and related with the observations in IAAC FM 003 and IAF/ILAC A3, Annex I>> C. Evaluation team recommendation to the MLAG <<The recommendation to the MLA Group should reflect the consensus of the evaluation team. If the evaluation team cannot reach consensus, the recommendation shall reflect the different views of the team members and include the reasons for the difference. Date of Issue: August 31, 2018 IAAC MD 048/18 Page 4 of 5

5 In the case where the team recommends suspension of the AB from the MLA, the recommendation shall indicate the reason for the suspension including the MLA scopes that are affected, with reference to the relevant findings.>> <<As relevant>> for example: <<The evaluation team recommends that <<insert acronym of AB>> maintains its signatory status of the IAAC MLA since have completed a satisfactory transition process to ISO/IEC 17011:2017>> D. Annexes: An annex using IAF/ILAC A3, Annex I, with the nonconformities, and when applicable, it should include the AB's responses. An Annex with form FM 003, where it states the documents and records reviewed by the evaluation team to verify the transition process an any other comments related with the transition process performed by the AB. Date of Issue: August 31, 2018 IAAC MD 048/18 Page 5 of 5