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 organization’s 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
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
4.2.3
Documents to ensure effective planning, operation, and control
of processes
Documents required by QMS are controlled
Procedures are in place ensure that documents are reviewed
and updated as necessary
Additional Questions
Observation and Comments
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
•
•
•
•
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
ISO Registration Process
Registrar Selection
Documented Quality System Audit
Certification Audit
Process Audit
Final Certification Audit
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 system’s 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.