Question: You have been engaged as a consultant to design, develop and implement QMS based on ISO 9001:2015, for a pharmaceutical company manufacturing vaccines for Covid-19.

You have been engaged as a consultant to design,

You have been engaged as a consultant to design, develop and implement QMS based on ISO 9001:2015, for a pharmaceutical company manufacturing vaccines for Covid-19. With suitable assumptions clearly stated, a. Identify and show the processes and their interactions through a high-level block diagram. (2 marks) b. Identify at least four risks for the organization. (2 marks) c. For each of the identified risks, outline the mitigation steps that you would recommend to the management. (2 marks)

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