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.

Thursday, May 6, 2010

CE MDD

We can undertake CE marking of the following:

1. Medical use equipment (direct contact with patient) based on IEC 60601 family of standards
2. Laboratory use medical / pharma testing and measuring equipment based on IEC 61010 family of standards

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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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Thursday, May 6, 2010

CE MDD

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