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Acceptance of test results from Manufacturers' Test Laboratories (MTL) within the MAA

46 th CIML, 10-14 October 2011. Acceptance of test results from Manufacturers' Test Laboratories (MTL) within the MAA Agenda item 10.3.3 Roman Schwartz. Manufacturers' Test Laboratories (MTL) within the MAA.

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Acceptance of test results from Manufacturers' Test Laboratories (MTL) within the MAA

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  1. 46th CIML, 10-14 October 2011 Acceptance of test results from Manufacturers' Test Laboratories (MTL)within the MAA Agenda item 10.3.3 Roman Schwartz

  2. Manufacturers' Test Laboratories (MTL) within the MAA References:1. Working Document (version 3) - 46th CIML Meeting 2011, item 10.3.3: OIML TC3/SC5 proposal for a CIML Resolution on the acceptance of manufacturers' test results within the MAA 2. Addendum 10.3 to 46th CIML Working Document, No 2: TC3/SC5 Report to the CIML (22 March 2011): Taking into account test results from Manufacturers' Testing Laboratories (MTL) under controlled supervision by the Issuing Participants in DoMCs

  3. Background 43rd CIML Meeting, 2008, Resolution No 20:"... For the time being, Issuing Participants shall not issue OIML MAA Certificates in the event that results of tests outside the scope of the DoMCs are taken into account (e.g. test results from manufacturers) in the Evaluation Reports. In this case an OIML Basic Certificate may still be issued as long as the MAA does not provide this possibility. The Committee supports the intention of TC 3/SC 5 to further discussthe acceptance of manufacturers’ test results, with the aim of ultimately including them in the scope of the MAA if consensus can be reached on the conditions to be applicable to manufacturers ISO/IEC 17025 test laboratories."

  4. What happened since 2008? (1) April 2009: Two voluntary, complete peer assessments of the MTLs of two well-known European weighing instrument manufacturers were performed in accordance with the OIML MAA rules (organized by PTB): • Assessment team: 2 assessors: lead (Brian Beard, ZA) and technical/ metrological expert (Michael Denzel, DE) were chosen from the official MAA list of experts (OIML/ILAC/IAF) 3 observers (from ZA and DE) • Duration: 5 days (1 day for preparation + 2 days for each MTL) • Assessment reports: Complete final reports (including non-conformities found) were made available to CPR and TC3/SC5 members

  5. Conclusions of the assessors for both MTLs • “…The quality system was found to be suitable and effective for the activities of the laboratory and it was adequately entrenched and maintained. • Four non-conformities were found and these related to the lack of policies and procedures regarding the formal registering of application for type approvals with the Issuing Authority, ... • Once the above non-conformances have been addressed it isconcluded that the laboratory will be suitable as a test laboratoryfor providing test results according to OIML R 76 to the … IssuingAuthority for evaluation of conformity under the DoMC for R 76.”

  6. What happened since 2008? (2) June 2009: 4th CPR meeting (Bern/CH): • Presentation and discussion of conclusions of the final assessment reports • Subsequent CPR inquiry  agreement on an MTL proposal  TC3/SC5 October 2010: TC3/SC5 meeting (Paris/FR): • Discussion of a new MTL concept developed on the basis of CPR proposals MTLs under controlled supervision by the Issuing Participants in DoMCs • Proposal to add (for the time being) an option for IPs in a DoMC to accept MAA Reports with MTL test data "on a voluntary basis" • Subsequent inquiry  agreement on MTL Report and Draft CIML Resolutions September 2011: 5th CPR meeting (Braunschweig/DE): • Presentation of the new concept and discussion of the Draft CIML Resolutions

  7. Assess.team CPR + MTL OIML MAACertificate+MAA TypeEvaluationReport CompleteMAA assessmentprocedureaccording toISO/IEC 17025... MTL Discussion in TC3/SC5 about a "fast track"  Draft CIML Resolutions(item 10.3.3) voluntaryacceptance MTL under controlled supervision by an IP DoMC IP1: TL IP2: TL UP: no TL B10:2011(CIML Res.item 10.3.2) 2. IP1 1. 3. New revisionof / orAmend-mentto B10:2011 IP2 ... with additional safeguards: 1. Controlledsupervision 2. Independence + impartiality 3. Initial inter- comparison UP

  8. Draft CIML Resolution proposed by TC3/SC5 Further to Resolution No 20 at the 43rd CIML Meeting, Issuing Participants may request the registration of Manufacturers’ Testing Laboratories (MTLs) under a DoMC, provided that the conditions agreed by TC 3/SC 5 and laid down in a respective amendment to OIML B 10 are met. OIML MAA Type Evaluation Reports that contain test results from MTLs may be accepted by Participants on a voluntary basis.

  9. Draft Resolution No. ...1 (Agenda item 10.3.3) Draft Resolution No. … The Committee, Noting the report of TC 3/SC 5 on the issue of the acceptance of manufacturers’ test results within a DoMC under the MAA, Recalling its Resolution No. 20 at the 43rd CIML Meeting, Decides - that Issuing Participants may request the registration of Manufacturers’ Testing Laboratories (MTLs) under a DoMC, provided that the conditions agreed by TC 3/SC 5 and laid down in a respective amendment to OIML B 10 are met, - that OIML MAA Type Evaluation Reports that contain test results from MTLs may be accepted by Participants on a voluntary basis.

  10. Amended Resolution No. ...1 (Agenda item 10.3.3) As an outcome of the discussions at the 5th CPR meeting (September 2011), an improved (unambiguous) version of this Resolution is suggested which is in line with the intention of TC3/SC5: Draft Resolution No. … The Committee, Noting the report of TC 3/SC 5 on the issue of the acceptance of manufacturers’ test results within a DoMC under the MAA, Recalling its Resolution No. 20 at the 43rd CIML Meeting, Decides - that Issuing Participants may request the registration of Manufacturers’ Testing Laboratories (MTLs) under a DoMC, provided that the conditions agreed by TC 3/SC 5 and laid down in a respective amendment to (or revision of) OIML B 10 are met, and that after this amendment to (or revision of) B10, OIML MAA Type Evaluation Reports that contain test results from MTLs may be accepted by Participants on a voluntary basis.

  11. Draft Resolution No. ...2 (Agenda item 10.3.3) Only in case of a positive CIML vote on Resolution ...1 the CIML is asked to vote on another Resolution as regards MTLs: Draft Resolution No. … The Committee, Recalling its Resolution No. xx, Approves as a new work item for OIML TC 3/SC 5: - the revision of OIML B 10 “Framework for a Mutual Acceptance Arrangement on OIML Type Evaluations (MAA)” to include appropriate conditions for the registration of Manufacturers’ Testing Laboratories (MTLs) under a DoMC, Decides - that the registration of MTLs under a DoMC remains excluded from the scope of the MAA, until this revision of OIML B 10 is approved.

  12. Amended Resolution No. ...2 (Agenda item 10.3.3) Again, as an outcome of the discussions at the 5th CPR meeting (September 2011), a slightly changed version is suggested which brings this Resolution in line with Resolution No. ...1: Draft Resolution No. … The Committee, Recalling its Resolution No. xx, Approves as a new work item for OIML TC 3/SC 5: - the amendment to (or revision of) OIML B 10 “Framework for a Mutual Acceptance Arrangement on OIML Type Evaluations (MAA)” to include appropriate conditions for the registration of Manufacturers’ Testing Laboratories (MTLs) under a DoMC, Decides - that the registration of MTLs under a DoMC remains excluded from the scope of the MAA, until this amendment to (or revision of) OIML B 10 is approved.

  13. Conclusion • After 6 years of discussions and 3 years of hard work, the presented concept of MTLs under controlled supervision by the Issuing Participants in DoMCs can be considered as mature enough to provide appropriate and effective safeguards that justify MTLs to be included in the scope of the MAA as soon as possible. • Nevertheless, in case of a positive CIML vote on the two MTL Resolutions, TC3/SC5 will have to re-discuss and elaborate the details in order to properly implement the concept in B10 on the basis of the MTL report of 22 March 2011. • The inclusion of MTLs in the scope of the MAA will certainly raise the number of MAA Certificates, because Issuing Participants will no longer be obliged to issue OIML Basic Certificates when they make use of test results from MTLs. • Opponents or still relunctant Participants in a DoMC will have the option to accept MAA Certificates and related MAA Type Evaluation Reports on a voluntary basis, until sufficient experiences have been gained with the new MTL concept which is similar to MTL concepts in other international certification schemes (e.g. IEC CB). • The CIML vote on the two MTL Resolutions will be a very important decision with far-reaching consequences for IPs, manufacturers and the future of the MAA.

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