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ISO 9000:2000 Internal Audits . Rene’ Jones October 7, 2003. Overview: ISO 9000:2000 Internal Audit. ISO Audit Requirements Getting Started Steps to an effective audit Planning Execution Follow up Cessna’s Approach. ISO 9000 Audit Requirements . Internal audits are required (4.17)

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iso 9000 2000 internal audits

ISO 9000:2000 Internal Audits

Rene’ Jones

October 7, 2003

overview iso 9000 2000 internal audit
Overview: ISO 9000:2000 Internal Audit
  • ISO Audit Requirements
  • Getting Started
  • Steps to an effective audit
    • Planning
    • Execution
    • Follow up
  • Cessna’s Approach
iso 9000 audit requirements
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

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.

benefits and uses
Benefits and Uses:
  • Can facilitate continuous improvement
  • Can Identify System Failures
  • Provide feedback to Management regarding efficiency of the Quality System
steps to a successful internal audit
Steps to a Successful Internal Audit
  • Decide the scope of the audit
    • Full
    • Partial
  • How will it be conducted
    • Upstream
    • Downstream
    • Across Processes
scope of the audit
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
how will the audit be conducted
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
steps to a successful internal audit cont
Steps to a Successful Internal Audit cont.
  • Develop a checklist
  • Perform the audit
  • Record findings
  • Follow-up
develop a checklist
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
sample checklist
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?

the internal audit
The Internal Audit
  • Maintain control of the audit
  • Be professional
  • Remain objective-look at the facts
  • Observe everything
audit interviews
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
audit interviews cont
Audit Interviews cont.
  • Minimize note taking during interview
  • Restate your understanding of their response
recording observations
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
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
car response
CAR Response
  • Must have specific details of implementation
  • Must have timeline for completion
report to management
Report to Management
  • Reports should be thorough and specific
  • Must be reviewed by management to be effective
the external audit
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
cessna s approach
Cessna’s Approach
  • Previous Audit System
    • Viewed as disruption
    • Viewed as a policing process
    • Viewed as non-beneficial
    • Program was suspended
cessna s approach22
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
  • How does auditing facilitate quality improvement?
  • What does ISO require in regards to audits?
  • Internal audits can be a tool for retaining certification
  • Can also be a tool for process improvement
  • Improves organizational awareness
  • Improves communication

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.

bibliography cont
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.

bibliography cont27
Bibliography cont.
  • Karapetrovic, Stanislov, and Wilborn, Walter; Audit System; Concepts and Practices. Total Quality Management, 09544127, Vol. 12, No. 1, January 2001