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International Organization for Standardization. www.iso.org. Mutual recognition ISO/IEC Guide 68:2002 by Mr. Graeme Drake Head of Conformity Assessment ISO Central Secretariat ISO CASCO/DEVCO – BIS Regional workshop on Certification New Delhi, India, 7 December 2004. To start with….

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  1. International Organization for Standardization www.iso.org

  2. Mutual recognition ISO/IEC Guide 68:2002 by Mr. Graeme Drake Head of Conformity Assessment ISO Central Secretariat ISO CASCO/DEVCO – BIS Regional workshop on Certification New Delhi, India, 7 December 2004

  3. To start with… • Arrangements versus agreements • Scope of the ISO/IEC Guide 68 • Guide for development, issuance and operation of arrangements for the recognition and acceptance of results of produced by bodies undertaking similar CA and related activities • Focused on the recognition and acceptance in the unregulated cross border marketplace • The Guide covers both: • basic elements of an arrangement/agreement, and • details on establishing the agreement group

  4. Elements of an agreement Introduction Signatories Scope Conditions of eligibility Individual obligations of signatories Collective obligations of signatories Relationship with other agreement groups Duration Points of contact Official signatures Conditions of amendment

  5. Establishing the agreement group Demonstration of conformity to internationally recognised requirements Direct method for demonstrating conformity e.g. peer assessment Indirect method for demonstrating conformity e.g. accreditation Other methods hybrid approaches

  6. Hybrid example using accreditation G2G MUTUAL RECOGNITION REGULATOR REGULATOR DESIGNATES DESIGNATES ACCREDITATION BODY A ACCREDITATION BODY B ACCREDITS ACCREDITS ISO/IECGuides and Standards ISO/IEC Guide 68 MRAs – Dec 2002 VOLUNTARY MUTUAL RECOGNITION CERTIFICATION BODIES CERTIFICATION BODIES CERTIFIES CERTIFIES Management System / Product/Personnel/ laboratories and tests Management System / Product/Personnel/ laboratories and tests

  7. Example using peer assessmentamongst certifiers CERTIFICATION BODIES CERTIFICATION BODIES confidence ISO/IECGuides and Standards ISO/IEC Guide 68 MRAs – Dec 2002 VOLUNTARY MUTUAL RECOGNITION through peer assessment CERTIFIES CERTIFIES Management System / Product/Personnel/ laboratories and tests Management System / Product/Personnel/ laboratories and tests

  8. Procedures for transparency and access to documentation Methods of test and inspection Methods to evaluate measurement facilities and calibration of test equipment Methods to control environmental test conditions Test, inspection and report forms Procedures for evaluation of a report resulting in a decision to approve or not to approve Means of communicating positive or negative test results Application procedures Peer assessment and accreditation procedures Internal harmonisation

  9. Making MRAs work Correct tool for level of confidence Level of commitment Potential influences on MRA development and implementation Regulation, regulators and standards Resource intensive negotiation Fear of the end game

  10. Checklist for potential MRA signatories Gain commitment from decision makers Be prepared to make internal changes to facilitate MRA process Identify and allocate adequate resources to MRA negotiation, maintenance and promotion Use international standards • Clearly identify the target of the MRA and match it to your own needs • Check what other tools or methods can be used to address the target • Vision the end game so all potential participants understand what the end result may be • Use a cost/benefit analysis

  11. Further information on conformity assessment can be found at the following link: http://www.iso.org/ or email Graeme Drake, Head of Conformity Assessment and Secretary of ISO/CASCO at drake@iso.org

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