iso-90012015-internal-auditor-course.pptx

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1. Internal Audit ISO 9001:2015

2. Auditing What is an audit? Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Why audit? ■ Requirement of ISO 9001 :2015 ■ Monitor and measure the management system ■ Promote continuous improvement of the management system

3. The primary purpose of internal audits is to: Evaluate Effectiveness: Assess the effectiveness of the organization's internal controls, processes, and systems. Ensure Compliance: Verify compliance with internal policies, procedures, and standards. Identify Improvements: Identify opportunities for improving processes and controls. Mitigate Risks: Detect and mitigate potential risks and nonconformities that could affect the organization’s objectives. Support Management: Provide management with independent and objective evaluations of internal processes and controls r ; Purpose of the Internal Audit

4. Verifies conformity to requirements Increases awareness and understanding Provides a measurement of effectiveness of the management system to top management Reduces risk of management system failure Identifies improvement opportunities Continuous improvement if performed regularly r ; Benefits of Auditing

5. Audit Characteristics Systematic (Planned): Audits are conducted in a planned and structured manner. Fact-Based : The purpose of an audit is to obtain facts (audit evidence), not to find personal or departmental faults. Tool for Continual Improvement : Audits are used as a tool for ongoing enhancement. Independent : Audits are based on impartiality and the objectivity of audit conclusions. Evidence-Based Approach : A rational method is used to reach reliable and consistent conclusions through a systematic audit process. Fair : Reporting is done accurately and truthfully.

6. Internal Audit Conducted by employees of the organization or by third parties within the organization. It focuses on evaluating the effectiveness of internal controls and processes. Purpose: To ensure that organizational processes are functioning as intended and in compliance with internal policies and procedures Scope: Covers internal operations, compliance with policies, and adherence to standards. Frequency: Performed periodically as scheduled by the organization’s audit plan. r ; Internal vs. External Audit External Audit Conducted by external entities or independent auditors who are not employees of the organization. Purpose: To provide an objective assessment of the organization’s adherence to external regulations, standards, and contractual obligations. Scope: Includes compliance with external standards, regulations, and contractual requirements. Frequency: Typically performed annually or as required by regulatory or contractual obligations.

7. ISO Requirements for Internal Audits ISO standards, such as ISO 9001:2015, provide specific requirements for internal audits: Planning : Establish an audit plan based on the importance of the processes and areas to be audited. Execution : Conduct audits in accordance with the planned schedule, using appropriate audit techniques and methods. Reporting : Document and communicate audit findings, including nonconformities, observations, and recommendations. Follow-up : Ensure that corrective actions are taken to address identified nonconformities and monitor their effectiveness.

8. The Audit Findings Audit findings are the results of the audit process, including: Nonconformities : Instances where processes or systems do not meet specified requirements. Observations : Comments or notes on areas of improvement that do not constitute nonconformities but may benefit from corrective action. Recommendations : Suggested actions for addressing nonconformities and improving processes.

9. Nonconformities Nonconformities are deviations from established requirements or standards and can be classified into two main types: Major Nonconformities: Significant deviations that affect the effectiveness of the QMS and may pose a serious risk to achieving the intended outcomes. Minor Nonconformities: Less severe deviations that do not impact the overall effectiveness of the QMS but still require corrective action..

10. Handling Nonconformities Identification: Detect and document nonconformities during the audit process. Reporting: Communicate nonconformities to relevant stakeholders. Corrective Action: Implement corrective actions to address the root cause of nonconformities. C orrective action requests (CARs) Verification: Verify that corrective actions are effective and prevent recurrence.

11. Observations Observations are noted during the audit that may indicate potential areas for improvement but do not necessarily indicate nonconformities. Observations can be: Opportunities for Improvement: Suggestions for enhancing processes or controls. Best Practices: Examples of effective practices that could be adopted elsewhere in the organization.

12. Audit Program

13. Audit Program Responsibilities

14. Auditor Competence

15. Auditor Responsibilities

16. With what? Resources Inputs From Whom/ Where How done? Methods/ Documentation With who? Personnel Outputs To Whom/ Where What results? Performance indicators

17. Audit Planning

18. Document Review Preparation Review relevant documents such as policies, procedures, and previous audit reports. Evaluation Assess the adequacy and effectiveness of documentation. Identify any discrepancies or areas for improvement.

19. Creation of the Checklist Developing the Checklist Outline key areas and processes to be audited. Include criteria based on standards and regulations. Ensure the checklist covers all aspects of the audit scope. 2. Validation : Review the checklist with stakeholders to ensure completeness and relevance.

20. Collecting and Verifying Information

21. THANK YOU

22. https://drive.google.com/file/d/16ZqdRA97nzzkvN6o42M3TU4mgcJk4Ynr/view?usp=sharing