Internal audits are a crucial component of an ISO 13485 Quality Management System (QMS). The audits need to be effective and deliver results (which are documented), otherwise there is little point in doing them! Auditing forms a necessary and valuable element to any management system; within an ISO 13485 certified QMS it can be of greater importance. Failure to review performance and ensure conformance with critical systems can have significant impact on the end users or patient recipient of a medical device.
Internal audits serve several important purposes:
- Ensuring Compliance: Internal audits help ensure that the QMS complies not only with ISO 13485 requirements but also with other relevant regulations. You can design your audits specifically to check that you are fulfilling such legal obligations whilst developing data and information you can show to the regulator that you are doing so. Auditing your systems for risk, post-market surveillance and technical file content (which you must do for ISO 13485) contributes to the regulatory framework that may be linked to your device.
- Identifying Areas for Improvement: By systematically reviewing processes and procedures, internal audits can identify areas where the QMS can be improved. This proactive approach helps in addressing potential issues before they become significant problems.
- Enhancing Efficiency: Internal audits provide an opportunity to streamline processes, making them more efficient. This can lead to cost savings and better resource utilization. Note, however, they can also be a means of checking that introduced changes are not impacting the final product.
- Risk Management: Regular internal audits help in identifying and mitigating risks associated with medical device manufacturing. This is vital for ensuring the safety and effectiveness of medical devices. The importance of ensuring risk management is robust is also key to compliance with requirements well beyond ISO 13485.
- Preparing for External Audits: Internal audits prepare the organization for external audits and visits by important customers by identifying and rectifying non-conformities in advance. This can lead to smoother external audit processes and fewer surprises. Good internal audits prepare you for unannounced audits!
By conducting regular internal audits, organizations can ensure that their MD QMS remains robust, compliant, and capable of delivering high-quality medical devices.
If you are having difficulty in developing the necessary skills to deliver your own ISO 13485 audits then contact QCS International where we can offer both internal and lead auditor courses to meet your needs.