When a conformity assessment body seeks designation to evaluate a particular product, process or service for compliance with essential requirements, the accreditation process shall incorporate elements which will permit assessment of the capability (technological knowledge and understanding of the generally stated risk protection requirements of the product, process or service or their use) of the conformity assessment body to evaluate compliance with those essential requirements. (b) Other means When appropriate accreditation is not available or when special circumstances apply, the designating authorities shall require the conformity assessment bodies to demonstrate their capabilities through other means such as:
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-participation in regional/international mutual recognition arrangements or certification systems,
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-regular peer evaluations,
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-proficiency testing, and
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-comparisons between conformity assessment bodies.
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C. EVALUATION OF THE DESIGNATION SYSTEM 7. Once the designation systems to evaluate the capabilities of conformity assessment bodies have been defined by each Party, the other Party may, in consultation with the designating authorities, check that the systems give sufficient assurance that the designation of the conformity assessment bodies satisfies its requirements.
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D. FORMAL DESIGNATION 8. Designating authorities shall consult the conformity assessment bodies within their jurisdiction in order to determine their willingness to be designated under the terms of this Agreement. Such consultation should include those conformity assessment bodies who do not operate under the respective legislative, regulatory, and administrative requirements of their own Party, but which may, nevertheless, be interested and capable of working to the legislative, regulatory, and administrative requirements of the other Party.
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9.Designating authorities shall inform their Party's representatives on the joint sectoral group, established under this Agreement, of the conformity assessment bodies to be included in or withdrawn from Section XX of the Sectoral Annexes. Designation, suspension or withdrawal of designation of conformity assessment bodies shall take place in accordance with the provisions of this Agreement and the rules of procedure of the joint sectoral group.
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10.When advising their Party's representative on the joint sectoral group established under this Agreement, of the conformity assessment bodies to be included in the Sectoral Annexes, the designating authority shall provide the following details in respect of each conformity assessment body: (a) the name; (b) the postal address; (c) the fax number; (d) the range of products, processes, standards or services it is authorised to assess; (e) the conformity assessment procedures it is authorised to carry out; and (f) the designation procedure used to determine capabilities.
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E. MONITORING 11. Designating authorities shall maintain, or cause to maintain, on-going surveillance over designated conformity assessment bodies by means of regular audit or assessment. The frequency and nature of such activities shall be consistent with international best practices or as agreed by the joint sectoral group.
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12.Designating authorities shall require designated conformity assessment bodies to participate in proficiency testing or other appropriate comparison exercises where such exercises are technically possible within reasonable cost.
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13.Designating authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment processes and procedures. This consultation may include joint participation in audits related to conformity assessment activities or other assessments of designated conformity assessment bodies, where such participation is appropriate and technically possible within reasonable cost.
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14.Designating authorities shall consult, as necessary, with the relevant regulatory authorities of the other Party to ensure that all regulatory requirements are identified and are satisfactorily addressed.