ISO 13485:2016 requires internal audits to be performed at scheduled intervals to determine whether the quality management system meets normative and regulatory requirements, is effectively implemented and is maintained.

In a documented procedure, the organization must set the requirements for planning and conducting internal audits. The internal audit process includes the creation of an audit program, which includes the planning of all audits taking place in the company. In addition to internal audits, (re)certification and other third-party audits or supplier audits can also be planned in the audit program. The audit program includes the definition of the audit criteria, audit scope, auditing frequency and audit method.

Audit records and their results must be maintained, including the audit plan and the audit report or deviation report. Deviations from the audit must corrected using suitable corrective measures including a detailed root cause analysis.

Auditors must be selected according to their experience, competence and training. Audits must be conducted objectively and impartially. Companies must ensure having enough trained auditors, which can be challenging for small companies as auditors are not allowed to audit their own activities. Depending on the complexity of the audit, it may be necessary to set up an audit team to ensure the competence needed to reach the audit objectives. ISO 19011:2018 requires that if the necessary competence cannot be covered by the auditors in the audit team, experts with additional competence to assist the team shall be provided.

Take advantage of our expertise and put your process to the test in accordance with ISO 13485:2016 Chapter 8.2.4. We can also prepare the necessary forms for you and describe the procedure for carrying out internal audits in accordance with normative requirements.
An internal audit by our experienced, certified lead auditors will give you an objective view of your quality management system. In accordance with the requirements of ISO 19011:2018, you will receive a detailed audit plan to determine the audit criteria and a final audit report to document the findings from the audit.