Good Afternoon all, This is my first post to the Forum! I have a question surrounding ISO13485:2016 Clause 8.2.4, mainly ensuring objectivity and impartiality of the audit process, Auditors shall not audit their own work. I am the QA/RA for a small business (15 employees), I have attended a 13485 lead auditors course and have been performing the Internal Audits within the company. I have previously audited my own work, found NCRs, and raised them for CAPA, and sign off by the CEO. But how do I demonstrate objectivity and impartiality? Is this going to be a case of bringing in an additional external company/person to audit my work?