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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.
DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, please contact TQMC.
The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.
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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:
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"What we didn't realize then was that
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It's surprising to find information from Inmetro in this blog. Thanks for disseminating Brazilian efforts to quality and safety!
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