Diapositive 1

1
TC 6 Meeting
MAA
2
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

3
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

4
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.

5
TC 6 Meeting
Prepackages
CountryA
CountryB
Manufacturer
Prepackages
6
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