iso 9000:2008 auditing ty stokes april 2010. agenda what is iso 9000:2008 auditing? brainstorming...
TRANSCRIPT
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?
• ChecklistBurr, John T. “Keys to a Successful Internal Audit.” Quality Progress (1997)
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.