ISO 9000-2008 Auditing

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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 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
• 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
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.

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