QMS Internal Audit Exam

Regularly scheduled audits should be implemented when any of the situations mentioned in the options arises. This means that if significant changes are made in functional areas of the quality system, if there is suspicion that service to customers is in jeopardy due to quality system nonconformities, or if a review indicates that previously unsuspected areas of the organization may be contributing to problems, then regularly scheduled audits should be conducted. The answer implies that any of these situations can trigger the need for audits to ensure the quality system is functioning effectively.

Selecting auditors who are independent of the area to be audited is a key point in an audit team selection because it ensures impartiality and objectivity in the audit process. When auditors are independent, they are not influenced by personal or professional relationships with the individuals or departments being audited. This helps to maintain the integrity of the audit and ensures that the audit findings and recommendations are unbiased and reliable.

The correct answer is "Necessary correction and corrective actions shall be taken by Management Responsible for the section." This answer accurately reflects the responsibility of the management in addressing and resolving nonconformities and their causes within their specific section. It emphasizes the need for corrective actions to be taken by the management responsible for the area where the nonconformities were detected.

An authentic audit program requires endorsement/approval from top management for an independent and formal audit. This ensures that the audit is conducted in a fair and unbiased manner, as top management's approval signifies their commitment to transparency and accountability. It also allows for an independent evaluation of the organization's processes and controls, providing valuable insights and recommendations for improvement. Without top management's endorsement, the audit may lack credibility and may not be viewed as a reliable assessment of the organization's performance.

The requirement for conducting Internal Audit is not specified in any of the clauses mentioned. Internal Audit is a separate process that is conducted to assess the effectiveness of the Quality Management System and ensure compliance with relevant standards and regulations. However, the specific clause that outlines the requirement for conducting Internal Audit may vary depending on the specific quality management standard being followed, such as ISO 9001.

ISO 9001:2008 requires companies to identify the processes within their organization and calibrate the measuring equipment used in those processes. This means that the company must determine which processes are critical to the quality management system and ensure that the measuring equipment used in those processes is calibrated to provide accurate and reliable measurements. Calibration is important to ensure that the measurements taken are consistent and meet the required standards.