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Question 1 of 30
InnovTech Solutions, a medium-sized manufacturing company, achieved ISO 9001:2015 certification two years ago. Despite this, the organization struggles to effectively integrate risk management into its Quality Management System (QMS). While they conduct periodic risk assessments as a separate activity, the findings are not consistently linked to QMS processes, leading to reactive responses to quality issues rather than proactive prevention. The quality manager, Anya Sharma, observes that different departments use varying risk assessment methodologies, and there\'s limited communication regarding potential quality-related risks across the organization. During a recent internal audit, several nonconformities were identified, highlighting the disconnect between risk management efforts and the actual quality performance. Anya is tasked with improving the integration of risk management within the QMS to enhance its effectiveness and ensure alignment with ISO 9001:2015 requirements. Which of the following actions would MOST effectively address InnovTech Solutions\' challenge of integrating risk management into its QMS, considering the requirements of ISO 9001:2015 and the need for a cohesive, proactive approach?
Establish a structured framework that integrates risk management into all relevant QMS processes, including defining risk criteria, conducting risk assessments, developing risk treatment plans, and implementing monitoring and review mechanisms, ensuring alignment with quality objectives.
Focus solely on improving the documentation of risk assessments, ensuring that all departments use the same templates and reporting formats to facilitate better data analysis and reporting for senior management.
Outsource the entire risk management function to a specialized consulting firm to ensure compliance with ISO 9001:2015, while keeping the existing QMS processes separate and unchanged.
Conduct annual risk management training sessions for all employees, emphasizing the importance of risk awareness, without modifying the existing QMS processes or establishing a formal risk management framework within the QMS.

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