ISO 9000:2008 Auditing

Ty Stokes
April 2010
 Agenda
What is ISO 9000:2008 auditing?
Brainstorming activity
Background of ISO 9000:2008 auditing
Audit process
Real world examples
Exercise
Summary
ISO 9000:2008 Auditing Defined

Review of an organizations quality system in

order to achieve quality throughout the
process
 Brainstorming Exercise
How can this tool be used in your
organization?
How would ISO 9000 auditing improve the
quality of products in the company?
 ISO 9000:2008
Group of standards for quality management systems
including:
Procedures for key business processes
Process monitoring to ensure effectiveness
Keeping records
Checking output for defects
Regularly reviewing individual processes
Facilitating continual improvement
 ISO 9000:2008 Standards
ISO 9000:2008 Fundamentals and Vocabulary

ISO 9001:2008 Requirements

ISO 9004:2008 Guidelines for Performance

Improvement

Why is the update important for auditing?

 Reasons for Audits
Verify processes
Assess successful process implementation
Judge effectiveness of target levels
Reduce and eliminate problem areas
Report non-conformance and corrections
Report good practices
Continual improvement
 Types of Audits
Internal Audits
Performed by trained employee
External Audits
Independent audit organization
Certification
 Internal Audit
Before the audit:
Plan the audit
Scope?
How will it be conducted?
Burr, John T. Keys to a Successful Internal Audit. Quality Progress (1997)

Checklist
 Checklist Example
Standard Question Observation and Comments
4.2.1 The QMS documentation includes:
Documented statements of a quality policy and objectives

A quality manual

Documented procedures and records required by ISO

9000:2008

Documents to ensure effective planning, operation, and control

of processes
4.2.3
Documents required by QMS are controlled

Procedures are in place ensure that documents are reviewed

and updated as necessary

Additional Questions
 Internal Audit (Continued)
During the audit:
Maintain control
Ask good questions and focus on interview
Record observations
Follow up
 Additional Things to Remember
During Audit
Dont be biased
Keep an open mind
Be patient
Remember that the audit is for continuous
improvement
Always state the facts
Report accurately and clearly
ISO Registration Process
 External Audits
Documented Quality System Audit
Onsite audit of QMS
Certification Audit
Sample of business processes
Process Audit
Optional
 External Audits
Final Certification Audit
Determines systems effective implementation
Continual Certification Audits
After certification
Ensure continued implementation
 A Real World Example:
Astro Aerospace
Wanted to be a Boeing supplier
AS 9100 audits (aerospace specification
supplement to ISO 9001)

The successful completion of this audit reflects our commitment to quality and

customer satisfaction. The results of this audit also provide the framework for

Astro to meet our customer's and industry's standard.

 A Real World Example:
Bristow Group
Set an ambitious goal to exceed SMS
requirements
Have frequent audits to monitor and control
processes
Audits lead to continuous improvement
 Exercise
Think of something you do everyday

Write down the process involved

What improvements can be made?

 Why is this important?
What is the purpose of an audit?
Why is this important?
Will this be beneficial to the customer?
Will this be beneficial to the company?
 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
 Additional Readings
Barnes, Frank. Good Business Sense is the
Key to Confronting ISO 9000. Review of
Business (2000): 11-15.
Burr, John T. Keys to a Successful Internal
Audit. Quality Progress (1997): 75-77.
ISO 9001:2008 Self Assessment Checklist,
Quality Management System, Feb 2009
 Additional Readings
Evans, Andy and Parker, John. Beyond
Safety Management Systems. AeroSafety
World (2008): 12-17
Ni, Zhijiang and Stanislav Karapetrovic.
"Perennial self-audit: model and
applications." Managerial Auditing Journal
(2003): 363-373.
 Additional Readings
www.qualityprogress.com
Foster, S. Thomas. Managing Quality:
Integrating the Supply Chain. 4th Edition.
Prentice Hall, 2010. 85-91.