Certbie
Question 1 of 30
SureSafe Medical is preparing for its annual ISO 13485:2016 internal audit. The audit team consists of employees from various departments, including the production manager, who is responsible for auditing the production processes. The audit plan includes a review of the design and development process, but the audit criteria are not clearly defined, and there is no documented procedure for conducting internal audits. Furthermore, previous audit reports have not been reviewed to identify trends or recurring nonconformities. Given this scenario, what is the MOST critical action SureSafe Medical must take to improve its internal audit process and ensure compliance with ISO 13485:2016 requirements?
Revise the internal audit process to ensure objectivity and impartiality by excluding the production manager from auditing production processes, develop clearly defined audit criteria, establish a documented procedure for conducting internal audits, and review previous audit reports to identify trends or recurring nonconformities.
Continue with the current audit plan, as the audit team is already assembled and the audit is scheduled to begin soon.
Outsource the entire internal audit process to a third-party consulting firm, as this is the most efficient way to ensure compliance with ISO 13485:2016.
Focus solely on reviewing the design and development process, as this is the most critical area of the QMS, and neglect other areas.