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.

Tuesday, June 2, 2009

WHO Inspects Indian Regulatory Authorities for Pharma and Clinical Trials

WHO auditors inspect Indian regulatory authority again, gives 100 score

Tuesday, April 28, 2009 08:00 IST
Joseph Alexander, New Delhi

WHO inspectors along with drug control officials from other countries, held a comprehensive audit of the national regulatory authority (NRA) in India and gave a high score of 100

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ISO 9000 Quality Management Systems

Tuesday, June 2, 2009

WHO Inspects Indian Regulatory Authorities for Pharma and Clinical Trials

WHO auditors inspect Indian regulatory authority again, gives 100 score

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