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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