ISO/IEC 17025:2017 - Testing and Calibration Laboratories Lead Auditor Quiz 08 24Mar25 - Practice Quiz

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Question 1 of 30

MediCorp Solutions, a medical device manufacturer, is struggling to meet the traceability requirements of ISO 13485:2016. Their complex supply chain involves numerous suppliers and outsourced processes, and their various software systems (ERP, MES, CRM) are not fully integrated. This has led to difficulties in uniquely identifying and tracking each medical device, its components, and its production history from raw materials to distribution. Several near-miss incidents involving potential product recalls have highlighted the urgency of improving their traceability system. The Chief Quality Officer, Dr. Anya Sharma, is tasked with implementing a solution that aligns with ISO 13485:2016 and relevant regulatory requirements like the FDA\'s UDI rule and the European MDR. Which of the following approaches would be MOST effective for MediCorp Solutions to enhance its traceability system and ensure compliance?

Implement a comprehensive system that includes Unique Device Identification (UDI), robust data management practices, and integration with their ERP, MES, and CRM systems to track devices from raw materials to post-market surveillance.

Focus solely on improving supplier audits and increasing the frequency of inspections to ensure that suppliers are adhering to MediCorp Solutions' traceability requirements.

Implement a new training program for all employees involved in the production process, emphasizing the importance of accurate record-keeping and adherence to standard operating procedures.

Outsource the entire traceability process to a third-party logistics provider that specializes in medical device tracking and compliance, thereby shifting the responsibility for traceability.

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