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.
In conjunction with the publication of ISO 9001:2008, Quality management systems - Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommitte SC 2, Quality systems, has published a number of guidance modules:
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