ISO 9000 Quality Management Systems: Pharma Summit Asia

Monday, October 19, 2009

Pharma Summit Asia

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Manufacturer's Responsibility

Responsibility of manufacturers

The CE marking must be affixed by the manufacturer or his agent established within the Community. The manufacturer bears ultimate responsibility for the conformity of the product.

Conformity assessment relates to the design and production phases of the product. Depending on the conformity assessment procedures applied, a notified body may be involved in these two phases. If the notified body is involved in the production control phase, its identification number will follow the CE marking.

If a product falls within the scope of a directive that provides for the CE marking, this should be affixed:

to all new products, whether manufactured in the Member States or in third countries;
to used and second hand products imported from third countries.

“There is only one boss. The customer. And he can fire everybody in the company from the chairman on down, simply by spending his money somewhere else.”
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ISO 9000 Quality Management Systems

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Monday, October 19, 2009

Pharma Summit Asia

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