ISO 13485:2016 Internal Auditor Quiz 09 24Mar25 - Practice Quiz

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Question 1 of 30

MediCore Innovations, a medical device company specializing in diagnostic equipment, is undergoing a significant organizational restructuring. The CEO, Dr. Anya Sharma, aims to improve the company\'s efficiency and responsiveness to rapidly changing market demands. This restructuring involves launching several new initiatives: developing a next-generation MRI scanner, expanding into telehealth services, and streamlining the supply chain. Dr. Sharma recognizes the need for a robust project management approach to ensure these initiatives are aligned with the company\'s strategic goals and that resources are allocated effectively. Considering the principles of ISO 21502:2020 and the need for strategic alignment across multiple projects and programmes, which of the following approaches would be most effective for MediCore Innovations to implement during this restructuring phase? The company also needs to comply with FDA regulations and maintain its ISO 13485 certification throughout the changes.

Establish a comprehensive portfolio management framework that integrates with the company's strategic planning process, ensuring all projects and programmes align with MediCore's overall objectives and optimize resource allocation.

Implement a centralized Project Management Office (PMO) to standardize project management methodologies across all departments and provide training to project managers on ISO 13485:2016 requirements.

Focus on programme management to coordinate the interrelated projects (MRI scanner, telehealth, supply chain), ensuring efficient delivery and benefits realization within each programme.

Deploy project management methodologies for each individual initiative (MRI scanner, telehealth, supply chain) without a centralized oversight function, allowing each project team to operate independently.