ISO 9000 Quality Management Systems

ISO 9001:2008 is no more just QMS, it is now a Business Management System that requires you to do RISK Management when designing the QMS. You have to understand the Risks to the business, and determine the Processes to be develoed. This may require you to do HACCP studies, if you are a food processor, and understand Product liability and the implications of Product Recall as in ISO/PC 240. For guidance in designing your QMS, you must refer to ISO 9004:2009.

Wednesday, August 12, 2009

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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.

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ISO 9000 Quality Management Systems

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Wednesday, August 12, 2009

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