Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.
Reference:
ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking