41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

TC 6 Meeting

OIMLCertif

T.A.Manuf.

I. Partic. U. Partic.

T.A.

MAA

41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

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

41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

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

41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

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.

TC 6 Meeting

41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

CountryA

CountryB

Manufacturer

Prepackages

Lic.

IQMark

Nat.Mark

Lic.

Nat.Mark

DirectAccept.

Prepackages

TC 6 Meeting

41st CIML Meeting and Associated Events

Cape Town, South Africa 11-20 October 2006

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 17021ISO 17020

Prepacker:ISO 9001

Building confidence

TC 6 Meeting