To better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 13485:2016 requirements state about why we do internal audits. What does ISO 13485:2016 require the internal audit to do? Although audit checklists are not stated as a requirement in the ISO 13485:2016 standard, they are a widely used and important tool to make sure that when you perform an internal audit on a process, you do not miss any elements of that process. The ISO 13485:2016 requirements are very clear that this is a critical element of your QMS and, since you want to know how your processes are functioning, your internal audits become a key resource. If you are interested in MDSAP learn more here.One of the most important checking tools in a Quality Management System (QMS) for medical devices, or any management system, is the internal audit. MDSAP is a program which allows a manufacture to receive a single audit to meet up to five regulatory quality system requirements at a single cost. These are typically conducted by your registrar annually.Īnother type of certification audit that Medical Device companies oftentimes prefer is the Medical Device Single Audit Program (MDSAP). Surveillance audits are very much like certification audits, with the exception that they are not issuing or re-issuing a certificate. Certification audits are typically conducted every three years.Īfter certification, your registrar will check-up on your periodically using surveillance audits to verify you are still upholding your QMS and the ISO requirements. This is where the auditor will interview your staff and review your documented information (procedures, records, etc.) to verify you are meeting all the ISO 13485 requirements. Stage two audits will always be on-site audits. If the auditor determines you meet the minimum criteria for the stage one audit, your organization will proceed with the stage two audit. Stage one is oftentimes conducted remotely in order to not spend additional costs on travel. Stage one audit is performed to determine an organization’s readiness for stage two of the audit. Certification audits are conducted in 2 stages. This will allow you to correct your QMS and ensure you that your organization will meet the requirements for the external auditor and allow for certification.Ī certification audit is the audit your selected registrar will conduct to verify conformance against the ISO 13485 standard before they issue your official ISO 13485 certificate. When you perform an internal audit, you will be able to compare your quality management system to the requirements and understand if there are any non-conformances. Internal audits will be used to assess conformity, evaluate effectiveness and identify opportunities for improvement. (We offer internal audit training to ensure your internal auditors are able to perform an effective internal audit as well as an audit checklist to help guide your internal auditors on covering all areas of your QMS.) Internal audits are an ISO 13485 requirement and they are critical to the success of your QMS. (It is recommended to have more than one auditor to ensure no one is auditing his or her area of responsibilities). The internal auditor must be independent of the area being audited to ensure objective results. Internal audits have many benefits including preparing your organization for external audits. Internal audits are audits that are performed by your organization and are a self-examination of your organization’s QMS, performed on-site.
ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.