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Question 1 of 30
\"Innovations in Motion,\" a multinational engineering firm specializing in precision automotive components, is transitioning its Quality Management System (QMS) from ISO 9001:2008 to ISO 9001:2015. During an internal audit, the lead auditor, Anya Sharma, focuses on the Design and Development department. The department head, Dr. Kenji Tanaka, insists that their existing design review process implicitly addresses potential risks and opportunities, as required by the new standard, even though no formal risk assessment methodology is documented or consistently applied. Anya discovers that recent product recalls due to design flaws could have been prevented with a more systematic approach to risk identification and mitigation during the design phase. Considering the requirements of ISO 9001:2015, what specific evidence should Anya Sharma expect to find within the Design and Development department to demonstrate effective integration of risk-based thinking?
Documented evidence of risk assessments conducted for design and development processes, showing how identified risks and opportunities inform design decisions, verification, validation activities, and change management, along with records demonstrating consistent application of these assessments.
A statement from Dr. Tanaka asserting that the department's experience and expertise implicitly address potential risks, eliminating the need for formal documentation, alongside testimonials from senior engineers confirming their intuitive understanding of potential failure modes.
Records of customer complaints and feedback demonstrating a reactive approach to addressing design flaws after product release, accompanied by evidence of corrective actions implemented to resolve identified issues.
A comparison of design specifications from previous projects, demonstrating that the department has consistently adhered to industry best practices and regulatory requirements, regardless of formal risk assessments.

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