Internal Audit (QMS) – Briefing and Training

[Audio] We are here to provide a briefing and training on conducting Internal Audits (Q-M-S--). Our presentation will cover the requirements and provide explanations of each element. We will also discuss the Medical Device Single Audit Program (M-D-S-A-P) and its audit elements. Our aim is to give you a comprehensive understanding of the internal audit process and how to effectively conduct internal audits in your organization. We believe that this knowledge will help you improve the quality and safety of your medical devices and enhance patient care..

[Audio] Internal audits must be conducted according to a documented procedure to ensure the ongoing effectiveness and conformity of the Q-M-S-. The frequency of audits may vary depending on the organization's size complexity and risk profile. Audit criteria and scope should be defined including ISO 13485 requirements regulatory requirements organizational policies objectives and processes. Competent auditors should be selected to assess the Q-M-S and identify areas for improvement. Audit results should be documented including non-conformities and opportunities for improvement. Follow-up activities should be conducted to verify the effectiveness of corrective actions and close identified non-conformities to ensure the Q-M-S continues to meet ISO 13485 requirements and organizational objectives over time..

[Audio] Medical device manufacturers are invited to attend a briefing and training on the Internal Audit (Q-M-S--) process. The presentation is known as JB-05-202. M-D-S-A-P is a regulatory audit that simplifies the process for manufacturers and ensures compliance across multiple countries. Participating authorities include the F-D-A (U S ) Health Canada and other regulatory agencies. The audit covers various aspects such as management device marketing authorization facility registration measurement and improvement medical device adverse events design and development production and service controls and purchasing. By attending this audit manufacturers can improve safety and oversight of their products and services while ensuring regulatory compliance..

[Audio] The process flow for conducting an effective internal audit is presented outlining the steps that an auditor must follow. The auditor proceeds to conduct the audit following the guidelines provided in ISO 19011 and any other relevant procedures and standards. Once the audit is completed any nonconformities found are submitted to the Q-S-E department which documents the audit findings and escalates any nonconformities in SmartSolve. This process is designed to ensure systematic and effective audits which helps improve the quality and efficiency of management systems..

[Audio] During the audit process the Team Lead holds numerous responsibilities. These include coordinating with the auditee and the audit team to establish the audit schedule executing the audit and preparing the audit checklist. The Team Lead must also ensure that any N-C-R C-A-P-A or RA is verified before closing the action item and that effective communication is maintained with the Lead Auditor and audit team. Furthermore the Team Lead must promptly address any concerns or issues raised by the audit team to ensure that the audit is conducted in accordance with the audit scheme and within the time frame..

[Audio] We conducted an internal audit of the Recruitment & Training process in the Human Resources department. The audit report was submitted to Q-S-E including audit findings recommendations and corrective actions. The audit report was reviewed by the Quality Assurance team to ensure compliance with ISO 13485:2016 standard. The audit was conducted in accordance with the procedure number 6610 and the audit findings were recorded using the JB-05-403 Internal Audit Checklist. Auditors identified conformities and nonconformities during the audit and the audit report was acknowledged by the auditee for major minor opportunities for improvement good practices and no findings..

[Audio] The procedure number referenced in the presentation is 6610. The checklist is created based on relevant documents standards and the M-D-S-A-P audit approach and IA strategy. It should contain at least 2 – 3 questions from the M-D-S-A-P audit model for each group. Audit evidence should align with the audit question. If you ask to audit 3 samples write down the details of those 3 samples in the audit evidence. If you ask about the person in charge or training please write down the employee no. or position and date of training of the audited person. Sample you take should be from the passed 6 months as Internal audit happens twice yearly. Please ensure that the correct standard ISO13485:2016 clause is addressed in each row especially for other requirements than ISO13485:2016. You may address the respective clause in the column Additional requirement/regulation column. Address C-A-P-A or N-C-R number in the audit checklist – Q-S-E will give you the final copy of NCR/CAPA for printing and sign off..

[Audio] During the internal audit (Q-M-S--) briefing and training different types of audit findings can be identified. These findings can be either conformity or nonconformity. Nonconformities occur when there is a failure to fulfill a specified requirement. This can include minor nonconformities significant failures to implement and maintain conformance to the requirements of applicable standards and several recurrent nonconformities that could result in the probable shipment of NC products. Additionally audit findings can include minor issues that could lead to major NCs failures to comply with applicable standards or legislations and single observed lapses in following on items of a company's Q-M-S--. However it is important to note that additional effectiveness or robustness might be possible with a modified approach to audit findings. Other findings such as observations comments or recommendations outside the applicable standards can also be identified. Overall our goal is to provide a comprehensive overview of the different types of audit findings and how they can help improve your company's Q-M-S-..

[Audio] We conduct an Internal Audit briefing and training today. Our presentation JB-05-202 contains various documents related to this topic. Important documents such as the BCS JB Legal and Regulatory the Internal Audit Management Procedure and the Internal Audit Checklist will be discussed. Additionally we will be discussing the Corrective and Preventive Action Working Instruction 0301640 GOP Risk Management Procedure 0320650 and other important documents related to our internal audit process..

2024 1st Internal Audit (QMS). 10.