Iso 9000 2000 Internal Audits

1. ISO 9000:2000
Internal Audits
Rene’ Jones
October 7, 2003

2. Overview:
ISO 9000:2000 Internal Audit
• ISO Audit Requirements
• Getting Started
• Steps to an effective audit
– Planning
– Execution
– Follow up
• Cessna’s Approach

3. ISO 9000 Audit
Requirements
Internal audits are required (4.17)
• Must be conducted by personnel
independent of responsibility for
process being audited
• Results must be recorded
• Must follow organizational objectives
• Frequency should be determined by
the organizational need

4. Defined:
An ISO 9000:2000 internal audit is
a method for verifying the
efficiency and performance of
an organizations quality system.
It ensures that the quality
system meets or exceeds the
required standard for
certification by the chosen
registrar.

5. Benefits and Uses:
• Can facilitate continuous
improvement
• Can Identify System Failures
• Provide feedback to Management
regarding efficiency of the Quality
System

6. How does this apply to my
organization?

7. • Decide the scope of the audit
– Full
– Partial
• How will it be conducted
– Upstream
– Downstream
– Across Processes
Steps to a Successful
Internal Audit

8. Scope of the Audit
• 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

9. How Will the Audit Be
Conducted
• Upstream-starting with the final
process and working backwards
to the beginning
• Downstream-starting with the
first process and flowing
forward
• Horizontal-across similar
processes

10. Steps to a Successful
Internal Audit cont.
• Develop a checklist
• Perform the audit
• Record findings
• Follow-up

11. Develop a Checklist
• Become familiar with the processess
and the associated documentation to
be audited
• Make notes on possible questions
• List items to look for and observe
• Note paragraph of the standard
being checked next to the item being
audited
• Leave space to record observations
• Use only one sheet per process or
area

12. Sample checklist
Wavesolder Process 3/3.0
Component and Board Handling 3/3.2
Are components labeled and stored properly? ________
Are operators following proper board handling procedures? ______
Safety Procedures 3/3.6
Are operators wearing appropriate safety equipment? ________
Is the area clean and obstacle free? ____________
Interview two operators
What is the procedure for loading a board into the machine?
How far apart should the boards be in the machine
When is it necessary to wear safety glasses?

13. The Internal Audit
• Maintain control of the audit
• Be professional
• Remain objective-look at the
facts
• Observe everything

14. Audit Interviews
• Ask open-ended questions
• Use hypothetical questions
• Encourage free speaking
• Observe body language of the
interviewee and adapt question
if needed
• Maintain eye contact

15. Audit Interviews cont.
• Minimize note taking during
interview
• Restate your understanding of
their response

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

17. Non-conformances
• Issue Corrective Action
Requests (CAR)
– Make sure it is thorough
– Note ownership
– Note the paragraph of the standard
that has been violated
– State requirements of resolutions

18. CAR Response
• Must have specific details of
implementation
• Must have timeline for
completion

19. Report to Management
• Reports should be thorough and
specific
• Must be reviewed by
management to be effective

20. The External Audit
• Prior to the audit by the
registrar
– Let employees know what to
expect from the external audit
– Let employees know what is
expected of them

21. Cessna’s Approach
• Previous Audit System
– Viewed as disruption
– Viewed as a policing process
– Viewed as non-beneficial
– Program was suspended

22. Cessna’s Approach
• New Audit System
– Thorough Phased Procedure
Developed
– Teams with representatives from
each quality department
– Monthly rolling audits
– Fosters continuous improvement of
their quality system

23. Quiz
• How does auditing facilitate
quality improvement?
• What does ISO require in
regards to audits?

24. Summary:
• Internal audits can be a tool for
retaining certification
• Can also be a tool for process
improvement
• Improves organizational
awareness
• Improves communication

25. Bibliography:
Mills,Charles A.; The Quality Audit, A
Management Evaluation Tool. USA:
McGraw-Hill, 1989.
Goetsch, David L., and Davis, Stanley
B.; ISO 9000 and ISO Standards.
Upper Saddle River, NJ: Prentice-
Hall, 2000.
Craig, Robert J.; The No Nonsense
Guide to Achieving ISO 9000
Registration. New York: The
American Society of Mechanical
Engineers, 1994.

26. Bibliography cont.
Burr John T.; Keys to a Successful
Internal Audit.Quality Progress, Vol.
30, No. 4, April 1997.
Eaton, Brian D.J.; Cessna’s Approach
to Internal Quality Audits. IIE
Solutions, 10851259, Volume 27, No.
6, June 1995.
Beeler, Dewitt L.; Internal Auditing:
The Big Lies. Quality Progress, May
1999.

27. Bibliography cont.
• Karapetrovic, Stanislov, and
Wilborn, Walter; Audit System;
Concepts and Practices. Total
Quality Management, 09544127,
Vol. 12, No. 1, January 2001