2. Agenda
• What is ISO 9000:2008 auditing?
• Brainstorming activity
• Background of ISO 9000:2008 auditing
• Audit process
• Real world examples
• Exercise
• Summary
3. ISO 9000:2008 Auditing Defined
Review of an organization’s quality system in
order to achieve quality throughout the
process
4. Brainstorming Exercise
• How can this tool be used in your
organization?
• How would ISO 9000 auditing improve the
quality of products in the company?
5. 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
6. 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?
7. 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
8. Types of Audits
• Internal Audits
– Performed by trained employee
• External Audits
– Independent audit organization
– Certification
9. Internal Audit
Before the audit:
• Plan the audit
– Scope?
– How will it be conducted?
• Checklist
Burr, John T. “Keys to a Successful Internal Audit.” Quality Progress (1997)
10. 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
11. Internal Audit (Continued)
During the audit:
• Maintain control
• Ask good questions and focus on interview
• Record observations
• Follow up
12. Additional Things to Remember
During Audit
• Don’t be biased
• Keep an open mind
• Be patient
• Remember that the audit is for continuous
improvement
• Always state the facts
• Report accurately and clearly
14. External Audits
• Documented Quality System Audit
– Onsite audit of QMS
• Certification Audit
– Sample of business processes
• Process Audit
– Optional
15. External Audits
• Final Certification Audit
– Determines system’s effective implementation
• Continual Certification Audits
– After certification
– Ensure continued implementation
16. 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.”
17. 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
18. Exercise
• Think of something you do everyday
• Write down the process involved
• What improvements can be made?
19. 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?
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. 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
22. 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.
