This document provides an overview of internal auditing processes. It describes the purpose of internal audits as making employees aware of the need for audits, describing the auditing method, and training employees to be auditors. It defines internal audits as periodic, independent verification of activities, records, and processes to ensure conformance with ISO 9001. Benefits include facilitating improvement and identifying failures. The audit process involves scheduling, planning, execution, reporting, and follow-up. Audits are required by ISO 9001 and must be conducted independently, with documented results and following objectives. The document outlines steps for conducting successful audits, including developing checklists, performing the audit, and reporting findings.

1. Introduction
• The purpose of this session is to:
– Make audit trainees aware of the need for internal audits
– Describe the method for internal audits
– Train employees to become internal auditors

2. Introduction
• During this session we will look at:
– Why we need to perform internal audits
– What an internal audit is
– Who needs to be audited
– When audits are to be performed
– How to perform an internal audit

3. Defining the Internal Audit
• Periodic, independent , documented verification of:
– Activities
– Records
– Processes
– Performance
• To ensure the management system conforms to
the requirements of ISO 9001.

4. Benefits of Auditing
• Can facilitate continuous improvement
• Can Identify System Failures
• Provide feedback to Management regarding
efficiency of the Quality System

5. Audit Objectives
• To verify that the quality system:
– Conforms to ISO 9001
– Processes conform to requirements
– Helps the organization to satisfy its customers
• To identify weakness in processes
• To acquire data and information
– To help make balanced decisions
– To help make decisions based on fact

6. Audit System Structure
• The internal audit process covers:
– Scheduling
– Planning
– Execution
– Reporting
– Follow-up

7. Audit System Structure
• The system combines 3 functions required
by ISO 9001:
– Management Representative schedules
audits and maintains the audit system
– Internal Auditors perform audits and reports
findings
– Management Review Team reviews the audit
findings

8. Audit Requirements
• Internal audits are required by ISO 9001
– Must be conducted by personnel independent
of responsibility for process being audited
– Results must be recorded
– Must follow organizational objectives
– Frequency is determined by organizational
need

9. Scheduling Audits
• All QMS processes are subject to auditing
– Each process is audited at minimum once in a
12 month period
– Audit scheduling is performed by the Quality
Management Representative
– The schedule is issued to Auditors & Auditees

10. Audit Scope
• Full audit of the entire Quality System
– How many auditors will be needed
– How will responsibilities be divided
– Appoint a lead auditor to keep the audit
focused
• Partial
– Which departments or processes
– Which clause of the standard

11. Audit Overview
• The typical audit cycle will include:
– Arranging a time and date for the audit
– A preparation stage
– Performing the audit on the scheduled date
– Compilation of the audit report
– Summary of non-conformance reports
– Review of any corrective actions proposed
– Verification of any corrective actions implemented

12. How Audits are Conducted
• Upstream
– starting with the final process and working
backward to the beginning
• Downstream
– starting with the first process and flowing forward
• Horizontal
– across similar processes, e.g. auditing document
control across all departments

13. Performing an Audit
• Audit arrangement
• Audit preparation
• Performance of the audit
• Compilation of the audit report
• Non-conformances and observations
– Minor/Major non-conformances
– Observations (opportunities for improvement)

14. Steps to a Successful Audit
• Review results of previous audits
• Determine priorities
• Develop the checklist
• Perform the audit
• Record findings
• Follow-up
• Review of corrective actions
• Verification of non-conformances

15. Develop the Audit Checklist
• Become familiar with:
– The processes being audited
– Documentation to be audited
• Make notes of possible questions
• List items to look for and observe
• Note the clause being checked
• Leave space to record observations

16. Audit Questions
• Use open questions to ensure you get full
answers:
– What are outputs does this process create?
– How do you know which document to use?
– Who is responsible for this process?
– When something goes wrong, what do you do?
– Where do you find work instructions and procedures?
• Open questions keep the auditee talking
• Avoid questions that illicit a ‘yes’ or ‘no’ response.

17. Recording Observations
• Record location of observation
• List the names of interviewees and their
position
• Notes on non-conformances should be
– short
– to the point
– thorough

18. Non-conformances
• Issue a Corrective Action Request
– Make sure it is thorough
– Note process ownership
– Note the paragraph of the standard that has
been violated
– State requirements of resolutions

19. Reporting to Management
• Reports must be
– thorough and specific
– objective
– evidence based
– reviewed by management

20. Summary
• Audits are important because they:
– Provide transparency
– Give a means for continual improvement
– Prove that standards are being followed
– Promote effective control
– Increase efficiency

21. End of Presentation
Thank you for your time.