Internal Audit Work Instructions PDF

Work Instructions **IAU-SOP-Internal Auditing** 1. Purpose This Work Instruction provides guidelines for performing internal audits to ensure compliance with the company's Quality Management System (QMS), regulatory requirements, and internal procedures. 2. Scope This Work Instruction applies...

Work Instructions **IAU-SOP-Internal Auditing** 1. Purpose This Work Instruction provides guidelines for performing internal audits to ensure compliance with the company's Quality Management System (QMS), regulatory requirements, and internal procedures. 2. Scope This Work Instruction applies to all departments and personnel involved in conducting, supporting, or being audited during internal audits at Symbiotic AI. 3. Roles and Responsibilities - Internal Auditor(s): Responsible for conducting audits in accordance with this Work Instruction. - Department Heads: Ensure the availability of resources and cooperation during the audit. - Regulatory Affairs and Quality Assurance Associate: Coordinates the internal audit schedule and approves audit reports. - Auditees: Provide the requested information and cooperate with auditors. 4. Definitions - Internal Audit: A systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively. - Non-conformance: A deviation from the established QMS, process, or regulatory requirement. 5. Instructions 1. Audit Program The Regulatory Affairs and Quality Assurance Associate is responsible to maintain a perennial audit program. The IAU-Internal Audit Program document is stored in Documents\>Template folder in the QMS tab of Formworks. A screenshot of a computer Description automatically generated Core processes should be audited at least annually, while processes presenting higher compliance risks based on previous audit findings, CAPAs or changes to the QMS system are audited more frequently. Before an audit, the Regulatory Affairs and Quality Assurance Associate should update the Internal Audit Program document with previous audit findings, CAPAs and changes made to the QMS. 2. Audit Planning The designated auditors prepare a separate audit plan, coordination is supported by the Regulatory Affairs and Quality Assurance Associate. The document IAU-Internal Audit Plan is used ad a guideline for the Audit Plan creation. This document is stored in Documents\>Template folder in the QMS tab of Formworks. The Internal Audit Plan is compiled by the Regulatory Affairs and Quality Assurance Associate and auditors to define the scope, objectives and participant.  Once an audit is scheduled, the Regulatory Affairs and Quality Assurance Associate informs the relevant team members to ensure they make themselves available for potential audit questions during the audit. 3. Conducting Audits Auditors will inspect the process records and interview members of the organization. Auditors are responsible for document collected evidence, observations and findings as part of the audit report. The template IAR-Internal Audit Report can be found on Documents\>Templates folder in the QMS tab of Formworks. A screenshot of a computer Description automatically generated 4. Audit Follow-up Once the audit is finalized and the findings, observations and evidence are documented in the Internal Audit Report, a follow-up should be initiated. In case major non-conformities are identified: Head of the department where non-conformities were identified will develop a CAPA to address the issue within \[X\] days. Regulatory Affairs and Quality Assurance Associate will report the audit findings to the Management as part of the next Management Review.