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This document outlines the framework for obtaining national type approval for prepackaged goods. It details the applicability to specific instruments, the roles of various participants, and the expected outcomes, including the issuance of around 50 certificates. The process involves recognition from at least 20 countries, where the capabilities of prepackers are assessed and certified. Prepackers receive licenses to affix conformity marks on their products. Compliance with ISO standards ensures quality assurance and inspection by relevant authorities, fostering trust in the certification process.
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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