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
 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
 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.
 Benefits of Auditing
• Can facilitate continuous improvement
• Can Identify System Failures
• Provide feedback to Management regarding
efficiency of the Quality System
 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
 Audit System Structure
• The internal audit process covers:
– Scheduling
– Planning
– Execution
– Reporting
– Follow-up
 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
 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
 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
 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
 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
 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
 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)
 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
 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
 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.
 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
 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
 Reporting to Management
• Reports must be
– thorough and specific
– objective
– evidence based
– reviewed by management
 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
 End of Presentation
Thank you for your time.