ISO 28000:2007 Transition Quiz 03 24Mar25 - Practice Quiz

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Question 1 of 30

Global Diagnostics, a manufacturer of in-vitro diagnostic devices, is facing challenges in reducing the number of nonconformities identified during internal audits. The quality manager, Anya Sharma, proposes implementing a new corrective action process. However, the proposed process relies heavily on anecdotal evidence and the opinions of senior management, without systematically analyzing data or identifying root causes. According to the principles of quality management outlined in ISO 13485:2016, what is the MOST critical weakness of Anya Sharma\'s proposed approach?

The lack of reliance on objective data and analysis to identify root causes and make informed decisions, which contradicts the principle of evidence-based decision-making.

The insufficient involvement of cross-functional teams in the corrective action process, which limits the diversity of perspectives and potential solutions.

The absence of a formal procedure for documenting the corrective action process, which makes it difficult to track progress and ensure accountability.

The failure to establish clear metrics for measuring the effectiveness of corrective actions, which makes it impossible to determine whether they are actually working.

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