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I. Partic. U. Partic. T.A. OIML Certif. T.A. Manuf. TC 6 Meeting. MAA. TC 6 Meeting. MAA: Applicable to a type of instrument Facilitates the obtention of national type approval National control is then applied to the production Typically for a DoMC:
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I. Partic. U. Partic. T.A. OIMLCertif T.A. Manuf. TC 6 Meeting MAA
TC 6 Meeting • MAA: • Applicable to a type of instrument • Facilitates the obtention of national type approval • National control is then applied to the production • Typically for a DoMC: • 15 Utilizing Participants (or more) • 7 to 10 Issuing participants • About 50 Certificates expected
TC 6 Meeting • Prepackages: • No specific type of prepackage • Applies to the production • Typically: • At least 20 countries/authorities to be recognized/accepted • Thousands of prepackers in each country • Millions of prepackages concerned
TC 6 Meeting Prepackages • General scheme: • Ability of the prepacker is assessed and certified • The prepacker is granted a licence to affix a conformity mark on his prepackages • The prepacker affixes the mark on his prepackages under his responsibility • The authority exerts inspections on the production.
Lic. Lic. Nat.Mark IQMark DirectAccept. Nat.Mark TC 6 Meeting Prepackages CountryA CountryB Manufacturer Prepackages
TC 6 Meeting Building confidence MAA Acceptance of Test Results Laboratories: ISO 17025 Prepackers Acceptance of QS evaluation reports Authority: ISO 17021 Prepacker: ISO 9001 Prepackages Acceptance of IQ Mark Authority: ISO 17021 ISO 17020 Prepacker: ISO 9001