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
Adherence to the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. It also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances.
The following principles relate to auditors.
Ethical conduct; trust, integrity, confidentiality and discretion are essential
Fair presentation; audit findings, conclusions and reports should be accurate
Due professional care; auditors must exercise care in accordance with the importance of the task they perform. Having the necessary competence is an important factor
Independence, auditors must be independent of the activity being audited
Evidence-based; evidence must be verifiable and based on samples information

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
Adherence to the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. It also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances.
The following principles relate to auditors.
Ethical conduct; trust, integrity, confidentiality and discretion are essential
Fair presentation; audit findings, conclusions and reports should be accurate
Due professional care; auditors must exercise care in accordance with the importance of the task they perform. Having the necessary competence is an important factor
Independence, auditors must be independent of the activity being audited
Evidence-based; evidence must be verifiable and based on samples information

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.
The internal audit is described as a systematic and documented verification process of objectively obtaining and evaluating evidence to determine whether an organization's quality management system conforms to the quality management system audit criteria set by the organization, and for communication of the results of this process to management.
ISO 9001:2008 requires that audits are undertaken to ‘determine whether the quality management system conforms to the requirements of ISO 9001:2008 and that the quality management system has been effectively implemented and maintained’.
Internal audits are a necessary tool to monitor and maintain the health of management systems. Audits are used to determine the extent management systems conform to requirements and whether they have been effectively implemented and maintained.

4. Benefits of Auditing Can facilitate continuous improvement
Can Identify System Failures
Provide feedback to Management regarding efficiency of the Quality System
The internal audit is described as a systematic and documented verification process of objectively obtaining and evaluating evidence to determine whether an organization's quality management system conforms to the quality management system audit criteria set by the organization, and for communication of the results of this process to management.
ISO 9001:2008 requires that audits are undertaken to ‘determine whether the quality management system conforms to the requirements of ISO 9001:2008 and that the quality management system has been effectively implemented and maintained’.
Internal audits are a necessary tool to monitor and maintain the health of management systems. Audits are used to determine the extent management systems conform to requirements and whether they have been effectively implemented and maintained.

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
The internal audit is described as a systematic and documented verification process of objectively obtaining and evaluating evidence to determine whether an organization's quality management system conforms to the quality management system audit criteria set by the organization, and for communication of the results of this process to management.
Audit objectives are based on:
Management priorities
Commercial intentions
Management system/statutory/regulatory/contractual requirements
Requirement for supplier evaluation
Customer requirements
Risks to the organization

6. Audit System Structure
The internal audit process covers:
Scheduling
Planning
Execution
Reporting
Follow-up
According to ISO 9001, organizations are required to develop, document, and perform internal audits in line with the organization’s quality system objectives. The audits must be performed by personnel independent of responsibility for the process being audited. Findings reports and Corrective Action Requests must be documented.

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
According to ISO 9001, organizations are required to develop, document, and perform internal audits in line with the organization’s quality system objectives. The audits must be performed by personnel independent of responsibility for the process being audited. Findings reports and Corrective Action Requests must be documented.

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
To ensure impartiality and objectivity, the audit team must include personnel from departments not directly associated with the area/department being audited. The internal audits are often assigned to the financial manager. However the quality manager, as the management representative, will usually maintain responsibility for the development and implementation of the quality audit activity.

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
The audit schedule is a living document and should not be cast in stone, but instead, it should be allowed to evolve organically with the needs of the business. Be sure to communicate the audit schedule and scope to all parties involved as well as to top management as this will help reinforce your mandate.

10. Audit Scope Full audit of the entire Quality System Partial
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)
Maintain control
As the auditor, you are in control of everything that happens
You are in control of who you speak to, the records you look at, and how much time to spend
Don’t resolve problems during the audit, suggestions for improvement may be made after the audit is completed
Be aware of your body language, the interviewee’s body language, and what is around you (much of the information comes from what is going on around you and not from what is heard)
Ask good questions
Ask open-ended questions to get more information
Avoid using rhetorical questions, assumptive questions, or leading questions as much as possible
Try using hypothetical questions
These types of questions can make the interviewee more comfortable and can lead to discussions
During the interview
Minimize note taking – if a note is needed, write down a key word during the interview and fill in the rest after the interview
Don’t jump to conclusions – verify what you understood by repeating what you heard back to the interviewee
Get the information and get out of the area as quickly as possible so as to disrupt the normal activity as little as possible
Avoid trying to understand the process – the auditor is there to make sure the interviewee understands the process
Record observations
Write down observations as clearly as possible while also keeping it brief
Make sure to state the paragraph of the associated ISO standard next to the observation
Follow up
Nothing will change if the audit is done but no follow up happens. Management must be held accountable and need to be followed up with to make sure corrective action has been taken.
Make the audit a learning experience for everyone involved.

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
The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure the audit addresses the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:
• Ensures the audit is conducted systematically
• Ensures a consistent audit approach
• Serves as an aide memoire to reference objective evidence
• Provides a repository for notes collected during the audit process
• Ensures uniformity in the performance of different auditors

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.
These basic audit questions will help guide the audit in the right direction since the answers they provide often unlock the doors to information the auditor requires in order to accurately assess the particulars of a process.
Audits are not designed to:
Catch people out
Make your job difficult
Assign blame for problems
If we DO what we say we are GOING to do, the audit is not a problem!
Finally, quality management system audits are not surprise audits! They are planned and everyone should know when they happen and what processes or departments will be audited. There should be no surprises, as this tends to foster mistrust towards the audit process, and a feeling of ‘them versus us’.

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.